BSO: Solving the risk/benefit equation

Translating Science into Sound Clinical Practice
BSO: Solving the
risk/benefit equation
Choosing candidates,
monitoring outcomes
Fetal U/S: How to
Put Safety First
Is ‘Progress’ Good
for Your Practice?
7 Ways to Avoid
an Ob/Gyn Shortage
JULY 2011
BRIEF SUMMARY: See Package Insert for Full Prescribing Information. For further product information and
current package insert, please visit or call our medical communications
department toll-free at 1-800-934-5556.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed
estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial
hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including
directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy
in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding
[see Warnings and Precautions (5.3)].
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
[see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) in full prescribing information].
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and
deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of
treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo [see Warnings and
Precautions (5.2), and Clinical Studies (14.2) in full prescribing information].
The WHI Memory Study (WHIMS) estrogen alone ancillary study of WHI reported an increased risk
of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years
of treatment with daily CE (0.625 mg) alone, relative to placebo. It is unknown whether this finding
applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in Specific
Populations (8.5), and Clinical Studies (14.3) in full prescribing information].
In the absence of comparable data, these risks should be assumed to be similar for other doses
of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
[see Warnings and Precautions (5.2, 5.4), and Clinical Studies (14.2, 14.3) in full prescribing information].
The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke
and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment
with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to
placebo [see Warnings and Precautions (5.2), and Clinical Studies (14.2) in full prescribing information].
The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing
probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment
with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether
this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in
Specific Populations (8.5), and Clinical Studies (14.3) in full prescribing information].
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast
cancer [see Warnings and Precautions (5.3), and Clinical Studies (14.2) in full prescribing information].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE
and MPA, and other combinations and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the
shortest duration consistent with treatment goals and risks for the individual woman.
Treatment of Atrophic Vaginitis and Kraurosis Vulvae
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause
PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions:
• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active deep vein thrombosis, pulmonary embolism or a history of these conditions
• Active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of
these conditions
• Known liver dysfunction or disease
• Known thrombophilic disorders
• Known or suspected pregnancy
Risks From Systemic Absorption
Systemic absorption occurs with the use of PREMARIN Vaginal Cream. The warnings, precautions, and adverse
reactions associated with oral PREMARIN treatment should be taken into account.
Cardiovascular Disorders
An increased risk of stroke and deep vein thrombosis (DVT) has been reported with estrogen-alone therapy.
An increased risk of pulmonary embolism, DVT, stroke and myocardial infarction has been reported with
estrogen plus progestin therapy. Should any of these occur or be suspected, estrogens with or without
progestins should be discontinued immediately.
Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use,
hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history of venous
thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately.
In the Women’s Health Initiative (WHI) estrogen-alone substudy, a statistically significant increased risk of
stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) compared to women in
the same age group receiving placebo (45 versus 33 per 10,000 women-years). The increase in risk was
demonstrated in year one and persisted [see Clinical Studies (14.2) in full prescribing information]. Should a
stroke occur or be suspected, estrogens should be discontinued immediately.
Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women
receiving CE (0.625 mg) versus those receiving placebo (18 versus 21 per 10,000 women-years).1
In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported
in all women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to placebo (33 versus 25 per
10,000 women-years) [see Clinical Studies (14.2) in full prescribing information]. The increase in risk was
demonstrated after the first year and persisted.1
Coronary Heart Disease
In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as
nonfatal myocardial infarction [MI], silent MI, or CHD death) was reported in women receiving estrogen-alone
compared to placebo [see Clinical Studies (14.2) in full prescribing information].1
Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in
CHD events (CE 0.625 mg compared to placebo) in women with less than 10 years since menopause
(8 versus 16 per 10,000 women-years).
In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events
in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34
per 10,000 women-years).1 An increase in relative risk was demonstrated in year 1, and a trend toward decreasing
relative risk was reported in years 2 through 5 [see Clinical Studies (14.2) in full prescribing information].
In postmenopausal women with documented heart disease (n = 2,763), average age 66.7 years, in a controlled
clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement
Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit.
During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD
events in postmenopausal women with established coronary heart disease. There were more CHD events in
the CE plus MPA-treated group than in the placebo group in year 1, but not during subsequent users. Two
thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in
an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total
of 6.8 years overall. Rates of CHD events were comparable among women in the CE (0.625 mg) plus MPA (2.5
mg) group and the placebo group in HERS, HERS II, and overall.
Venous Thromboembolism (VTE)
In the WHI estrogen-alone substudy, the risk of VTE (DVT and pulmonary embolism [PE]) was increased for
women receiving daily CE (0.625 mg) compared to placebo (30 versus 22 per 10,000 women-years), although
only the increased risk of DVT reached statistical significance (23 versus 15 per 10,000 women-years). The
increase in VTE risk was demonstrated during the first 2 years 3 [see Clinical Studies (14.2) in full prescribing
information]. Should a VTE occur or be suspected, estrogens should be discontinued immediately.
In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE was reported
in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus
17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000
women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE
risk was observed during the first year and persisted 4 [see Clinical Studies (14.2) in full prescribing
information]. Should a VTE occur or be suspected, estrogens should be discontinued immediately.
If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with
an increased risk of thromboembolism, or during periods of prolonged immobilization.
Malignant Neoplasms
Endometrial Cancer
An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a
woman with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2- to
12-fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most
studies show no significant increased risk associated with use of estrogens for less than 1 year. The greatest risk
appears to be associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more, and
this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued.
Clinical surveillance of all women using estrogen-alone or estrogen plus progestin therapy is important. Adequate
diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to
rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
There is no evidence that the use of natural estrogens results in a different endometrial risk profile than
synthetic estrogens of equivalent estrogen dose. Adding a progestin to postmenopausal estrogen therapy has
been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
In a 52-week clinical trial using PREMARIN Vaginal Cream alone (0.5 g inserted twice weekly or daily for 21
days, then off for 7 days), there was no evidence of endometrial hyperplasia or endometrial carcinoma.
Breast Cancer
The most important randomized clinical trial providing information about breast cancer in estrogen-alone users is
the Women’s Health Initiative (WHI) substudy of daily CE (0.625 mg). In the WHI estrogen-alone substudy, after an
average follow-up of 7.1 years, daily CE (0.625 mg) was not associated with an increased risk of invasive breast
cancer [relative risk (RR) 0.80] 5 [see Clinical Studies (14.2) in full prescribing information].
The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin
users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg). After a mean follow-up of 5.6 years, the
estrogen plus progestin substudy reported an increased risk of breast cancer in women who took daily CE plus
MPA. In this substudy, prior use of estrogen-alone or estrogen plus progestin therapy was reported by 26 percent of
the women. The relative risk of invasive breast cancer was 1.24, and the absolute risk was 41 versus 33 cases per
10,000 women-years, for estrogen plus progestin compared with placebo.6 Among women who reported prior use
of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25
cases per 10,000 women-years for estrogen plus progestin compared with placebo. Among women who reported
no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was
40 versus 36 cases per 10,000 women-years for estrogen plus progestin compared with placebo. In the same
substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the CE (0.625 mg) plus
MPA (2.5 mg) group compared with the placebo group. Metastatic disease was rare, with no apparent difference
between the two groups. Other prognostic factors, such as histologic subtype, grade and hormone receptor status
did not differ between the groups [see Clinical Studies (14.2) in full prescribing information].
Consistent with the WHI clinical trial, observational studies have also reported an increased risk of breast cancer for
estrogen plus progestin therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use.
The risk increased with duration of use, and appeared to return to baseline over about 5 years after stopping treatment
(only the observational studies have substantial data on risk after stopping). Observational studies also suggest that
the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared
to estrogen-alone therapy. However, these studies have not generally found significant variation in the risk of breast
cancer among different estrogen plus progestin combinations, doses, or routes of administration.
The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in
abnormal mammograms, requiring further evaluation.
All women should receive yearly breast examinations by a healthcare provider and perform monthly breast
self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk
factors, and prior mammogram results.
Ovarian Cancer
The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer.
After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE plus MPA versus placebo, was
1.58 (95 percent nCI 0.77-3.24). The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per
10,000 women-years.7 In some epidemiologic studies, the use of estrogen-only products, in particular for 5 or
more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure
associated with increased risk is not consistent across all epidemiologic studies, and some report no association.
Probable Dementia
In the estrogen-alone Women’s Health Initiative Memory Study (WHIMS), an ancillary study of WHI, a population
of 2,947 hysterectomized women 65 to 79 years of age was randomized to daily CE (0.625 mg) or placebo.
In the WHIMS estrogen-alone ancillary study, after an average follow-up of 5.2 years, 28 women in the
estrogen-alone group and 19 women in the placebo group were diagnosed with probable dementia. The
relative risk of probable dementia for CE-alone versus placebo was 1.49 (95 percent nCI 0.83-2.66). The
absolute risk of probable dementia for CE-alone versus placebo was 37 versus 25 cases per 10,000
women-years 8 [see Use in Specific Populations (8.3), and Clinical Studies (14.3) in full prescribing information].
In the WHIMS estrogen plus progestin ancillary study, a population of 4,532 postmenopausal women 65 to 79
years of age was randomized to daily CE (0.625 mg) plus MPA (2.5 mg) or placebo.
After an average follow-up of 4 years, 40 women in the CE plus MPA group and 21 women in the placebo
group were diagnosed with probable dementia. The relative risk of probable dementia for CE plus MPA versus
placebo was 2.05 (95 percent nCI 1.21-3.48). The absolute risk of probable dementia for CE plus MPA versus
placebo was 45 versus 22 cases per 10,000 women-years 8 [see Use in Specific Populations (8.3), and Clinical
Studies (14.3) in full prescribing information].
When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative
risk for probable dementia was 1.76 (95 percent nCI 1.19-2.60). Since both substudies were conducted in
women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8
[see Use in Specific Populations (8.5), and Clinical Studies (14.3) in full prescribing information].
Gallbladder Disease
A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving
estrogens has been reported.
Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases.
If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the
serum calcium level.
(continued on next page)
Visual Abnormalities
Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending
examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine.
If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued.
Addition of a Progestin When a Woman Has Not Had a Hysterectomy
Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration or daily with
estrogen in a continuous regimen have reported a lowered incidence of endometrial hyperplasia than would be
induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.
There are, however, possible risks that may be associated with the use of progestins with estrogens compared
to estrogen-alone regimens. These include an increased risk of breast cancer.
Elevated Blood Pressure
In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic
reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen
therapy on blood pressure was not seen.
In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of
plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.
Hepatic Impairment and/or Past History of Cholestatic Jaundice
Estrogens may be poorly metabolized in women with impaired liver function. For women with a history of
cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and
in the case of recurrence, medication should be discontinued.
Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Women with normal thyroid
function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3
serum concentrations in the normal range. Women dependent on thyroid hormone replacement therapy who are
also receiving estrogens may require increased doses of their thyroid replacement therapy. These women should
have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.
Fluid Retention
Estrogens may cause some degree of fluid retention. Patients with conditions that might be influenced by this
factor, such as cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.
Estrogens should be used with caution in individuals with hypoparathyroidism as estrogen-induced
hypocalcemia may occur.
Exacerbation of Endometriosis
A few cases of malignant transformation of residual endometrial implants have been reported in women treated
post-hysterectomy with estrogen-alone therapy. For women known to have residual endometriosis posthysterectomy, the addition of progestin should be considered.
Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with
hereditary angioedema.
Exacerbation of Other Conditions
Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic
lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
Effects on Barrier Contraception
PREMARIN Vaginal Cream exposure has been reported to weaken latex condoms. The potential for PREMARIN
Vaginal Cream to weaken and contribute to the failure of condoms, diaphragms, or cervical caps made of latex
or rubber should be considered.
Laboratory Tests
Serum follicle stimulating hormone and estradiol levels have not been shown to be useful in the management
of moderate to severe symptoms of vulvar and vaginal atrophy.
Drug-Laboratory Test Interactions
Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count;
increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and
beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity;
increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by
protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3
resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women
on thyroid replacement therapy may require higher doses of thyroid hormone.
Other binding proteins may be elevated in serum, for example, corticosteroid binding globulin (CBG), sex
hormone-binding globulin (SHBG), leading to increased total circulating corticosteroids and sex steroids,
respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma
proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol
concentrations, increased triglyceride levels.
Impaired glucose tolerance.
The following serious adverse reactions are discussed elsewhere in the labeling:
• Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2)]
• Endometrial Cancer [see Boxed Warning, Warnings and Precautions (5.3)]
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
In a 12-week, randomized, double-blind, placebo-controlled trial of PREMARIN Vaginal Cream (PVC), a total
of 423 postmenopausal women received at least 1 dose of study medication and were included in all safety
analyses: 143 women in the PVC-21/7 treatment group (0.5 g PVC daily for 21 days, then 7 days off), 72 women
in the matching placebo treatment group; 140 women in the PVC-2x/wk treatment group (0.5 g PVC twice
weekly), 68 women in the matching placebo treatment group. A 40-week, open-label extension followed, in
which a total of 394 women received treatment with PVC, including those subjects randomized at baseline
to placebo. In this study, the most common adverse reactions * 5 percent are shown below (Table 1)
[see Clinical Studies (14.1) in full prescribing information].
Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Events * 5 Percent Only
Body Systema
Adverse Event
Number (%) of Patients with Adverse Event
Any Adverse Event
Body As A Whole
95 (66.4)
45 (62.5)
97 (69.3)
46 (67.6)
Abdominal Pain
Accidental Injury
Back Pain
Cardiovascular System
11 (7.7)
4 (2.8)
8 (5.6)
7 (4.9)
16 (11.2)
7 (4.9)
10 (7.0)
2 (2.8)
5 (6.9)
3 (4.2)
9 (12.5)
5 (6.9)
3 (4.2)
9 (6.4)
9 (6.4)
2 (1.4)
13 (9.3)
25 (17.9)
16 (11.4)
4 (2.9)
6 (8.8)
3 (4.4)
1 (1.5)
5 (7.4)
12 (17.6)
5 (7.4)
4 (5.9)
5 (3.5)
4 (5.6)
7 (5.0)
1 (1.5)
Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Events * 5 Percent Only
Digestive System
Musculoskeletal System
4 (2.8)
5 (3.5)
2 (2.8)
4 (5.6)
10 (7.1)
3 (2.1)
1 (1.5)
3 (4.4)
Nervous System
5 (3.5)
5 (6.9)
6 (4.3)
4 (5.9)
Respiratory System
6 (4.2)
3 (4.2)
4 (2.9)
4 (5.9)
Cough Increased
Skin And Appendages
Urogenital System
3 (2.1)
1 (0.7)
12 (8.4)
1 (1.4)
2 (2.8)
3 (4.2)
7 (9.7)
7 (5.0)
7 (5.0)
2 (1.4)
16 (11.4)
3 (4.4)
3 (4.4)
4 (5.9)
3 (4.4)
Breast Pain
8 (5.6)
1 (1.4)
4 (2.9)
3 (2.1)
2 (2.8)
4 (2.9)
6 (8.8)
8 (5.6)
3 (4.2)
7 (5.0)
3 (4.4)
Body system totals are not necessarily the sum of the individual adverse events, since a patient may
report two or more different adverse events in the same body system.
Postmarketing Experience
The following adverse reactions have been reported with PREMARIN Vaginal Cream. Because these reactions
are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.
Genitourinary System
Abnormal uterine bleeding/spotting, dysmenorrhea/pelvic pain, increase in size of uterine leiomyomata, vaginitis
(including vaginal candidiasis), change in cervical secretion, cystitis-like syndrome, application site reactions of
vulvovaginal discomfort, (including burning, irritation, and genital pruritus), endometrial hyperplasia, endometrial
cancer, precocious puberty, leukorrhea.
Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.
Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increase in blood pressure.
Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.
Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia.
Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria,
anaphylactic reactions, exacerbation of asthma, increased triglycerides, hypersensitivity.
Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.
No formal drug interaction studies have been conducted for PREMARIN Vaginal Cream.
Metabolic Interactions
In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4).
Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St.
John’s Wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma
concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine
bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and
grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.
PREMARIN Vaginal Cream should not be used during pregnancy [see Contraindications (4)]. There appears to be
little or no increased risk of birth defects in children born to women who have used estrogens and progestins as
an oral contraceptive inadvertently during early pregnancy.
Nursing Mothers
PREMARIN Vaginal Cream should not be used during lactation. Estrogen administration to nursing mothers has
been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have
been identified in the breast milk of mothers receiving estrogens. Caution should be exercised when PREMARIN
Vaginal Cream is administered to a nursing woman.
Pediatric Use
PREMARIN Vaginal Cream is not indicated in children. Clinical studies have not been conducted in the pediatric
Geriatric Use
There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMARIN
Vaginal Cream to determine whether those over 65 years of age differ from younger subjects in their response
to PREMARIN Vaginal Cream.
The Women’s Health Initiative Study
In the Women’s Health Initiative (WHI) estrogen-alone substudy (daily conjugated estrogens 0.625 mg versus
placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.2)
in full prescribing information].
In the WHI estrogen plus progestin substudy, there was a higher relative risk of nonfatal stroke and invasive breast
cancer in women greater than 65 years of age [see Clinical Studies (14.2) in full prescribing information].
The Women’s Health Initiative Memory Study
In the Women’s Health Initiative Memory Study (WHIMS) of postmenopausal women 65 to 79 years of age, there
was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus
progestin when compared to placebo [see Clinical Studies (14.3) in full prescribing information].
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these
findings apply to younger postmenopausal women 8 [see Clinical Studies (14.3) in full prescribing information].
Renal Impairment
The effect of renal impairment on the pharmacokinetics of PREMARIN Vaginal Cream has not been studied.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of PREMARIN Vaginal Cream has not been studied.
Overdosage of estrogen may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain,
drowsiness/fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation
of PREMARIN therapy with institution of appropriate symptomatic care.
This brief summary is based on PREMARIN Vaginal Cream Prescribing Information W10413C022 ET01, Rev 05/10.
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Anita O’Keeffe Young Professor of Women’s Health and Chair,
Department of Obstetrics, Gynecology and Reproductive Sciences,
Yale University School of Medicine, New Haven, CT
Professor and Chair, Department of
Obstetrics and Gynecology, Stanford
University School of Medicine; Director,
Women’s Cancer Center, Stanford
Cancer Center, Stanford, CA
Professor, Department of Obstetrics
and Gynecology, Chief, Division of
Gynecologic Specialties, Stanford
University School of Medicine,
Stanford, CA
Professor, Obstetrics, Gynecology, and
Reproductive Sciences, and Pediatrics,
Yale University School of Medicine,
New Haven, CT
Chair, Department of Obstetrics and
Gynecology, Cedars-Sinai Medical
Center, Los Angeles, CA
Norman F Miller Professor of
Gynecology, Director, Pelvic Floor
Research, Group Director, Fellowship
in Female Pelvic Medicine and
Reconstructive Surgery, University of
Michigan Medical School, Ann Arbor, MI
Professor, Department of Obstetrics and
Gynecology, University of New Mexico,
Albuquerque, NM
Clinical Professor, Department of Obstetrics
and Gynecology, NorthShore University
HealthSystem, University of Chicago,
Pritzker School of Medicine, Evanston, IL
Associate Professor, Department
of Gynecology and Obstetrics,
Emory University, Atlanta, GA
Professor of Obstetrics and Gynecology, Georgetown
University School of Medicine, Washington, DC
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JULY 2011
JULY 2011
VOL. 56, NO. 7
Translating Science into Sound Clinical Practice
BSO: Solving the
risk/benefit equation
Prophylactic bilateral salpingo-oophorectomy at
the time of hysterectomy confers long-term health
benefits for many women. Success lies in careful
candidate selection and monitoring of outcomes.
Is “progress” good
for your practice?
Although advancements in science allow us to
better treat patients, the industrialization and
bureaucratization of medicine have diminished
our status, job satisfaction, and income. Is there a
middle ground?
Fetal U/S: How to put safety first
Understanding potential risks and key safety issues
associated with fetal ultrasound is the foundation
for optimal use of this important imaging
An evolving specialty confronts
workforce changes
Industrialization of medicine:
Coming soon to a practice like
■ Increasing calcium intake
does not further reduce
fracture risk
A retained sponge following
hysterectomy raises the
question of who was negligent.
Changing workforce needs and expectations have
brought about an impending shortage of ob/gyns.
But with challenges come solutions, and initiating a
dialogue is the first step toward finding them.
CONTEMPORARY OB/GYN (Print ISSN#0090-3159, DIGITAL ISSN#2150-6264), is published monthly by Advanstar Communications, Inc, 131 West First St, Duluth, MN 55806-2065. One-year subscription
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JULY 2011
Have you heard?
Contemporary OB/GYN Newsline
is a FREE weekly e-newsletter for
OB/GYNs and staff, delivering practical
and timely specialty information
and updates.
Breaking Industry News
Regulatory Updates
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Translating Science into Sound Clinical Practice
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Your guide to what’s happening online at Contemporary
Contemporary OB/GYN is part of the ModernMedicine Network, a Web-based portal for health professionals
offering best-in-class content and tools in a rewarding and easy-to-use environment for knowledge-sharing among
members of our community.
Learn more about averting
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and improving fetal
FREE barcode scanning at
To join the conversation, use your smartphone
and scan the QR code, or go to:
Offer your patients with GERD this
downloadable, printable list of tips
for managing reflux:
View a robot-assisted hysterectomy
recorded at University Hospitals
Case Medical Center in Cleveland
Dr Joshua Copel blogs about
incentives for med students to
become primary care providers.
Endometrial ablation
superior in controlling
heavy menses
Endometrial ablation is less likely
than hysterectomy to lead to later
pelvic floor repair or surgery for
urinary incontinence.
The top ob/gyn clinical and practice management resources from
Preop progesterone helps
some BRCA patients
Progesterone before breast cancer
surgery provides a benefit to women
with node-positive disease, a
randomized clinical trial shows.
in pregnant
women may
worsen the
risk of fetal
VAP-1 predicts mortality in
patients with type 2 diabetes
The level of serum vascular adhesion
protein-1 can predict the 10-year
mortality risk in patients with type 2
People who get plenty of omega-3
fatty acids in their diets may have a
lower risk for type 2 diabetes.
Fetal risks differ among
anticonvulsant combos
Omega-3 fats linked to
lower diabetes risk
Abuse-resistant painkiller
gets FDA nod
The FDA has
approved a pain
drug designed
to combat the
abuse of opioidbased painkillers.
Early ART reduces HIV
transmission risk
Starting oral antiretroviral therapy
early in those with HIV substantially
reduces their risk of transmitting the
virus to uninfected sexual partners.
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JULY 2011
Drug Topics:
17OHP benefits prior preterm birth patients
Dr Charles Lockwood, one of the foremost authorities on
preterm birth, has written a balanced and factual editorial
laying out his view of progestin use today and in the future.1 However, although his editorial speculates that vaginal progesterone might eventually replace hydroxyprogesterone caproate (17OHP) for reducing the risk of preterm
birth, he still recommends 17OHP to treat prior preterm
birth patients. Why this apparent contradiction?
Te most obvious reason to recommend 17OHP is that
current evidence demonstrates that vaginal progesterone
is ineffective for patients with a prior preterm birth, but
shows benefit for short cervix patients. The da Fonseca
study using vaginal suppositories was only positive when
an analysis excluding many patients was performed2 and a
second, larger study using vaginal gel was negative.3 Te 2
prospective studies in which vaginal progesterone showed
benefit enrolled women with a short cervix, which represents only about 2% of pregnant women.4,5
Recent literature has documented the risks of serious
neonatal morbidity in late preterm births. Hydroxyprogesterone caproate in the National Institute of Child Health
and Human Development (NICHD) study6 is the only
progestin shown to reduce the number of preterm births
(defined as less than 37 weeks). Vaginal progesterone shifed early preterm births to late preterm births. Both the
da Fonseca and O’Brien prior preterm birth studies showed
no difference at less than 37 weeks when analyzed using the
intent-to-treat principle.2,3 Te short cervix studies either
did not report data afer 34 weeks4 or showed no difference
at less than 37 weeks.5 Further, a subanalysis of short-cervix
patients in the DeFranco study showed no difference at less
than 37 weeks.7 Terefore, no evidence currently exists that
vaginal progesterone has any impact on late preterm birth,
which represents the majority of preterm births. Only the
NICHD study of 17OHP demonstrates benefit for prior
preterm birth patients at early and late gestational ages.6
Tus, the real progestin story is that vaginal progesterone has an important role for short-cervix patients but is
unlikely to replace 17OHP for prior preterm birth patients
in the foreseeable future.
2. da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of
progesterone by vaginal suppository to reduce the incidence of spontaneous preterm
birth in women at increased risk: a randomized placebo-controlled double-blind study.
Am J Obstet Gynecol. 2003;188(2):419-424.
3. O’Brien JM, Adair CD, Lewis DF, et al. Progesterone vaginal gel for the reduction
of recurrent preterm birth: primary results from a randomized, double-blind, placebocontrolled trial. Ultrasound Obstet Gynecol. 2007;30(5):687-696.
4. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation
Second Trimester Screening Group. Progesterone and the risk of preterm birth among
women with a short cervix. N Engl J Med. 2007;357(5):462-469.
5. Hassan SS, Romero R, Vidyadhari D, et al. Vaginal progesterone reduces the rate
of preterm birth in women with a sonographic short cervix: a multicenter, randomized,
double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. April 6, 2011.
Epub ahead of print.
6. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by
17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-2385.
Erratum in: N Engl J Med. 2003:349(13):1299.
7. DeFranco EA, O’Brien JM, Adair CD, et al. Vaginal progesterone is associated with
a decrease in risk for early preterm birth and improved neonatal outcome in women
with a short cervix: a secondary analysis from a randomized, double-blind, placebocontrolled trial. Ultrasound Obstet Gynecol. 2007;30(5):697-705.
Dr Lockwood responds:
Tank you for your interest in my editorial. However, I
see no contradiction. I recommend vaginal progesterone
for incidentally found short cervices in women without prior preterm births and 17 hydroxyprogesterone
(17OHP) in women with prior spontaneous preterm
births. As I concluded: “Because the Hassan et al study
was underpowered to confirm whether cervical length
screening and vaginal progesterone therapy reduced
preterm births in previously affected women, and because a prior study by O’Brien and colleagues failed to
demonstrate that progesterone 90 mg vaginal gel reduced recurrent preterm birth before 33 weeks among
such women, I would still recommend treating patients
with singleton gestations and a prior spontaneous preterm delivery with weekly intramuscular injections of
17OHP obtained from the least expensive available and
reliable source.”
I then go on to speculate: “For these high-risk women,
additional studies are needed to determine whether sonographic cervical screening with vaginal progesterone is
more cost effective than prophylactic 17OHP therapy. In
addition, cerclage may be indicated in such women who
are found to have shortened cervices prior to 23 weeks.
However, if some combination of cerclage and/or vaginal
progesterone produces comparable or better rates of prematurity prevention, 17OHP therapy can be abandoned
once again.” Tus, I fail to see any contradiction.
Again, thanks for your interest. All the best,
1. Lockwood CJ. The real progesterone story. Contemp OB/GYN. 2011;56(5):10-15.
JULY 2011
A !
F D ed
ow ro
N pp
Knowing the Risk Matters
You know that HPV causes cervical cancer. You know that identifying the disease early helps
improve patient management decisions—and outcomes. But is pooled hrHPV testing enough?
Consider these facts:
s HPV genotypes 16 and 18 together account for nearly 70% of diagnosed
cervical cancers.
s In the ATHENA Study using the cobas® HPV Test, 1 in 10 women age 30 years
and older who tested positive for HPV 16 and/or 18, actually had cervical precancer, even though they had a normal pap result.
s The cobas® HPV Test is the only assay that provides specific genotyping
information for HPV genotypes 16 and 18, while simultaneously reporting the 12
other high-risk HPV types as a pooled result, so you can know more about
your patient s risk for cervical cancer.
Call your Roche Molecular Diagnostics Representative today or
visit to find out more.
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche.
© 2011 Roche Diagnostics. All rights reserved. 472-50537-0411
The cobas® HPV Test gives you the power to know more
about your patients risk for cervical cancer
Industrialization of medicine: Coming soon
to a practice like yours!
ow did it feel to live in New England in the
early 19th century and witness the Industrial
Revolution? Well, it likely depended upon
your perspective. If you were a wealthy mill owner,
it must have felt pretty good. If you were a former
farmer forced off your land by plummeting food prices
and now needing to work long hours in that mill for
pennies a day, probably not so good. Today we face the
industrialization of medicine and, again, how physicians
feel about it may depend upon our perspective. If you
are a Generation Y member seeking a fuller life outside
medicine, the future is bright. If you are a 60-something
solo practitioner who has worked 70-hour weeks for 35
years, the future might not seem quite so bright.
How did we get into this situation?
I have pointed out on these pages a number of times
that the United States expends up to 100% more than
other industrialized nations
for healthcare but is ranked
only 37th in healthcare
performance by the World
Health Organization.1 Despite
Data on the care you provide
spending more than 17% of our
could be made public under a
GDP on healthcare, Americans
proposed rule. Find out more:
receive about half of the
recommended preventive care.2
Conversely, while Medicare
spending patterns vary substantially among regions,
higher spending is not associated with better outcomes,
higher patient satisfaction, or improved access to care.3
Worse, preventable errors add billions to our collective
healthcare bill.4
Arguing that a relentlessly rising volume of care
driven by our discounted fee-for-service payment system
is exacerbating both cost inflation and suboptimal
Send your feedback to:
[email protected]
JULY 2011
care, the Centers for Medicare and Medicaid Services
(CMS) has decided to adopt value-based purchasing
(VBP).5 In brief, the CMS hospital VBP program
will affect inpatient Medicare payments beginning
in FY 2013 based on discharges accruing on or afer
October 1, 2012. Value-based incentive payments will
be made to acute care hospitals, depending on how
these hospitals perform on 25 CMS Hospital Compare
reporting measures. Tese 25 indices include 17 clinical
process-of-care measures (70% of bonus/risk) and 8
HCAHPS patient satisfaction measures (30% of bonus/
risk). Ultimately, higher rates of 30-day readmissions
and medical errors will be penalized. While superior
performance or solid improvement during a fiscal
year will yield a higher VBP payment, meeting bonus
thresholds will be difficult.
Te very best performing hospitals, those in the top
10%, will be eligible for extra compensation from the
pool of dollars withheld from the lower performing
hospitals.6 Conversely, hospitals with higher-thanaverage 30-day readmission rates for diagnoses such
as heart failure and pneumonia will face up to 1%
penalties starting in 2013, ramping up to 3% in 2015. To
meet these tough targets, hospitals will need to strictly
control physician practice. In fact, an astonishing 50%
of all physician practices are now owned by hospitals
or integrated delivery systems and the number of
physicians employed by hospitals has increased 75%
since 2000.7
But this strategy is not without risk for hospitals.
On average, they lose about $200,000 per year per
doctor over the first 3 years of physician employment.7
However, hospitals appear more than willing to accept
such losses in return for better control of patient
access and referrals as well as physician performance.
Moreover, if accountable care organizations begin
to dominate the market and hospital revenues
and expenses span both ambulatory and inpatient
environments, the incentive to acquire even marginally
performing physician practices will accelerate.
for your patients
• 350 mg — the highest level of DHA in an OTC prenatal vitamin
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Conversely, increasingly complex VBP, bundled charges,
and capitated payment models will make it harder and
harder for smaller physician practices to operate at a
profit independent of large organizations.
The healthcare industrial revolution
During my own residency, most community ob/gyns
were in solo practice or in groups of 2 at the most.
Such practices generally employed no more than a
nurse, receptionist, and a part-time bookkeeper; in
short, they were the equivalent
of a family farm. Now, as I look
around our service at Yale, no
obstetric providers remain in
solo practice and most practice
performance will
in groups of 5 or more physicians
become the standard
plus nurse practitioners and/
by which healthcare
or midwives. Office staffers
providers are judged.
are highly specialized in the
business side of medicine, with
Hospitals and large
group practices
some dealing only with claims
are absorbing solo
submission and others focusing
on managerial functions that
the solo physician used to
perform for himself or herself.
Also needed are information technology expertise,
specialized contracting assistance, and staff to ensure
that all physicians are credentialed with each payer. But
even these medium sized-practices may not have the
economies of scale necessary for optimal contracting,
efficient billing, sound practice management,
aggressive marketing, and the purchase of ever more
expensive equipment. Tus, in Connecticut and across
the country many practices now are actively seeking
purchase by, or other formal affi liation arrangements
with, medical schools and large hospitals. In short, the
practice of medicine has become a big and complex
business, and hospitals and physicians are looking
to each other to help find their way through all the
Take-home message
What should you expect? Over the next 5 years, I
predict that fee-for-service revenues will decline to
levels not seen since the late 1990s and commercial
payers will increasingly adopt such CMS payment
innovations as VBP, bundled (physician and hospital)
payments, capitated medical homes, and accountable
care payment schemes. T is will accelerate the drive to
an increasingly “corporate” healthcare delivery system.
Mandated publication of patient outcomes, satisfaction
scores, and cost of care will be rolled out to ensure that
JULY 2011
patients and their insurers seek the most efficacious,
timely, safe, and efficient options for care.
The inpatient environment will see increasing use
of standardized treatment protocols for common
diagnoses, fewer choices in OR equipment and
supplies, as well as mounting pressure to use fewer
diagnostic tests and more cost-effective medications.
Over time simple process measures, such as a patient
with pneumonia getting antibiotics within 6 hours of
presentation, will lose importance and true outcome
measures will move to the forefront. Policy decisions
will be made centrally, and employed physicians will
receive periodic “scorecards” measuring numbers of
patients cared for, patient satisfaction, and outcomes.
Finally, the cost of providing care will increasingly
be taken into consideration, such that physicians
who provide the highest quality of care for the
lowest cost will gain the most in compensation and
vice versa. Some will embrace this brave new world;
others will choose to retire. It will all depend on their
DR LOCKWOOD, editor in chief, is the Anita O’Keeffe Young Professor
of Women’s Health and Chair, Department of Obstetrics, Gynecology and
Reproductive Sciences, Yale University School of Medicine, New Haven,
1. World Health Organization. WHO World Health Report. The World
Health Organization’s ranking of the world’s health systems. Published
2000. Accessed May
15, 2011.
2. McGlynn EA, Asch SM, Adams J, et al. The quality of health care
delivered to adults in the United States. N Engl J Med.
3. Fisher ES, Wennberg DE, Stukel TA, Gottlieb DJ, Lucas FL, Pinder EL.
The implications of regional variations in Medicare spending. Part 2: health
outcomes and satisfaction with care. Ann Intern Med. 2003;138(4):
4. Porter ME, Teisberg EO. Redefining Health Care: Creating ValueBased Competition on Results. Boston, Massachusetts: Harvard
Business School Press; 2006.
5. US Department of Health and Human Services. Centers for Medicare
and Medicaid Services. Medicare program; hospital inpatient value-based
purchasing program. 45 CFR Parts 422 and 480. Final rule (May 6, 2011).
Federal Register. 2011;76(88):26490-26547.
6. US Department of Health and Human Services. Centers for Medicare
and Medicaid Services. Medicare program; hospital inpatient value-based
purchasing program. 45 CFR Parts 422 and 480. Proposed rules (January
13, 2011). Federal Register. 2011;76(9):2454-2491.
fdsys/pkg/FR-2011-01-13/pdf/2011-454.pdf. Accessed June 14, 2011.
7. Kocher R, Sahni NR. Hospitals’ race to employ physicians—the logic
behind a money-losing proposition. N Engl J Med. 2011;364(19):
Give your patients confidence in their test results. Start with the ThinPrep®
Pap test, the only pap test FDA approved as significantly more effective than
the conventional pap smear for early detection. Add Dual Review with the
ThinPrep Imaging System, proven to increase sensitivity and specificity over
manually reviewed ThinPrep Pap test slides.1 Then, increase sensitivity to
nearly 100% by recommending Cervista® HPV HR for women age 30 and
older or patients with inconclusive pap results.2 Every step you take with
ThinPrep and Cervista HPV leads to more accurate and reliable screening.
Take the next step. Visit today.
1 The Imager clinical trial results showed a statistically significant increase in ASCUS+ sensitivity of 6.4% [95% CI: 2.6-10.0], a statistically significant increase in HSIL+ specificity
of 0.2% [95% CI: 0.06-0.4], and a reduction in false negative fraction of 39% (based on ASCUS+ sensitivity). The unsatisfactory rate was not evaluated for statistical significance,
but a decrease was observed.
Ads-00196-001 Rev. 002
2 Consult package insert ( for full clinical details.
Increasing calcium intake
does not further reduce
fracture risk
Consuming more than 700 mg of calcium per day in
later years does not further reduce the risk for fracture
or osteoporosis and may, in fact, increase the risk for hip
fracture, according to the findings of a
large longitudinal and prospective cohort
study from Sweden. Te study involved
more than 61,000 women between 63 and
97 years of age participating in the Swedish
Mammography Cohort, established
in 1987. Of these, about 5,000 women
participated in a subcohort.
During 19 years of follow-up, almost
15,000 women, or just about one-quarter, experienced some
type of first fracture. Among those, 6% (3,871) experienced a
first hip fracture. Among the women in the subcohort, 20%
met the criteria for osteoporosis. Te researchers found that
the risk patterns associated with dietary calcium intake were
Raising the cutoff level
for a Hybrid capture 2 result
New findings indicate that the cutoff level for the Hybrid
capture 2 test (Qiagen; Gaithersburg, Maryland) for
primary screening for high-grade cervical intraepithelial
neoplasia (CIN) can be increased to reduce the burden
on women while still meeting international sensitivity
recommendations. Te findings come from a systematic
review of randomized controlled trials without metaanalysis, which was not possible because of the heterogeneity
of the trials.
Researchers found that the relative sensitivity for CIN
grade III or higher at cutoff levels of greater than or equal to
2, 4, 5, and 10 relative light units (rlu)/cutoff (co) compared
with a cutoff level of greater than or equal to 1 rlu/co varied
by trials. At their lowest, the values were 0.97, 0.92, and
0.91, respectively. Te investigators observed a similar
pattern for CIN grade II or higher. Tey also found that
specificity increased by at least 1%, 2%, and 3%, respectively,
JULY 2011
nonlinear. Tey calculated that the rate of a first fracture of
any type among women in the first quintile of calcium intake
(less than 751 mg per day) was 17.2 per 1,000 person-years at
risk; for those in the second quintile (751 to 882 mg per day),
the third quintile (882 to 996 mg per day), the fourth quintile
(996 to 1,137 mg per day), and the fifh quintile (greater than
1,137 mg per day), the rates were 14.7 (14.2 to 15.3), 14.0 (13.5
to 14.5), 14.1 (13.6 to 14.7), and 14.0 (13.5 to 14.5), respectively.
Tose in the lowest quintile were at
highest risk for a first hip fracture, with
an adjusted hazard ratio (HR) of 1.29 (1.17
to 1.43), but the group at next highest risk
for hip fracture was the fifh quintile,
with an adjusted HR for hip fracture of
1.19 (1.06 to 1.32). A low vitamin D intake
made the rate of fracture in the first
calcium quintile even more pronounced.
Adjusted odds ratios for osteoporosis from the first to the
fifh quintiles were as follows: 1.47 (1.09 to 2.00); 1.26 (0.99 to
1.60); 1.0 (reference); 0.92 (0.74 to 1.15); and 1.01 (0.81 to 1.27).
Warensjö E, Byberg L, Melhus H, et al. Dietary calcium intake and risk of fracture
and osteoporosis: prospective longitudinal cohort study. BMJ. 2011;342:d1473.
so that women could avoid up to 24%, 39%, and 53% of
false-positive Hybrid capture 2 test results (ie, results not
associated with high-grade neoplasia). For example, a cutoff
greater than or equal to 10 rlu/co reduced the risk for a falsepositive result by about one-half among women 30 years of
age and older. In younger women, the higher cutoff reduced
the risk for a false-positive result by about one-third.
Recently published international recommendations for
HPV screening in women 30 years of age and older require
that new tests to detect HPV DNA demonstrate 90% or
higher sensitivity for CIN grade II or higher compared
with the sensitivity of the Hybrid capture 2 test using the
cutoff greater than or equal to 1 rlu/co. In addition, experts
recommend that sensitivity of HPV screening for CIN grade
III or higher be above 90%. Te researchers concluded that
using a cutoff for the Hybrid capture 2 between greater than
or equal to 2 rlu/co and greater than or equal to 10 rlu/co
meets these requirements.
Rebolj M, Bonde J, Njor SH, Lynge E. Human papillomavirus testing in primary
cervical screening and the cut-off level for hybrid capture 2 tests: systematic review.
BMJ. 2011;342:d2757.
Clinical Insights
Women perceive USPSTF
mammogram guidelines
as unsafe
A survey of 247 women 39 to 49 years of age reveals that
89% think that women in their forties should continue
to receive yearly mammograms.
Researchers from the
University of Massachusetts
Medical School in Worcester
surveyed the women when they
came to the hospital for annual
well care visits. With regard to
the United States Preventive
Services Task Force (USPSTF)
2009 recommendations to
raise the minimum age at
which women receive regular
mammographic screening from
40 to 50 years, 86% of the women surveyed believed the
recommendations to be unsafe.
In fact, even if their physician recommended they do
so, 85% of the surveyed women reported that they would
not wait until age 50 years to obtain a mammogram. Te
Is mesh better than
colporrhaphy for pelvic
organ prolapse?
Compared with anterior colporrhaphy, a trocarguided transvaginal polypropylene mesh repair kit for
prolapse of the anterior vaginal wall (cystocele) results
in higher short-term success rates, but also higher rates
of surgical complications and postoperative adverse
events, according to the fi ndings of a multicenter,
parallel-group, randomized, controlled trial from
Researchers from Sweden, Finland, Norway, and
Denmark randomly assigned 389 women from 53
clinics to cystocele repair with a mesh kit (the same
type used routinely for hernias and incontinence) or to
traditional colporrhaphy.
At 1 year, using the Pelvic Organ Prolapse
Quantification system, almost twice as many women
(60.8%) who were treated with the mesh repair kit were
at the anatomical designation of stage 0 (no prolapse)
USPSTF guidelines also suggested that women between
the ages of 50 and 74 years do not need a mammogram
any more frequently than every 2 years.
Te researchers also found that 88% of the women
overestimated their lifetime risk for breast cancer.
Tose women who received previous false-positive
mammogram results and
those with a friend diagnosed
with breast cancer were even
less likely to accept delaying
screening until age 50 years.
Te researchers had the
women read a few articles on
the subject and then complete
the questionnaire. Tey found
that consistent and highprofi le media campaigns had
been effective over the years in
convincing women that early and
regular mammograms lead to early detection, which, in
turn, saves lives.
Davidson ATS, Liao X, Magee BD. Attitudes of women in their forties toward
the 2009 USPSTF mammogram guidelines: a randomized trial on the effects
of media exposure. Am J Obstet Gynecol. April 15, 2011. Epub ahead of print.
or 1 (position of the anterior vaginal wall more than
1 cm above the hymen) as those who underwent
colporrhaphy (34.5%) (absolute difference, 26.3
percentage points; 95% confidence interval [CI], 15.6
to 37.0).
However, surgery lasted longer and rates of
intraoperative hemorrhage were higher in the mesh
repair group than in the colporrhaphy group (P<0.001
for both comparisons), as were rates of bladder
perforation (3.5% vs 0.5%, respectively) and new stress
urinary incontinence (12.3% vs 6.3%, respectively).
In addition, 3.2% of the 186 women in the mesh
group required surgical intervention to correct mesh
exposure during follow-up. Investigators noted
complications for as long as 1 year afer surgery with
the mesh kit.
Te authors of the study concluded that physicians,
in collaboration with their patients, must weigh the
risks and benefits of each treatment option.
Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C, for the Nordic
Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh
for pelvic-organ prolapse. N Engl J Med. 2011;364(19):1826-1836.
JULY 2011
Retained sponge following hysterectomy:
Who was negligent?
A FLORIDA WOMAN underwent a hysterectomy
performed by her gynecologist in 2007. Tree months
later the patient returned with abdominal pain and was
diagnosed with appendicitis. She underwent emergency
surgery, during which a surgical sponge was discovered
in the abdominal cavity. Te patient had developed
an interabdominal infection that required a bowel
Te woman sued her gynecologist and the hospital,
alleging that they were negligent in leaving the sponge
behind during her hysterectomy. Te hospital settled
prior to trial, but the physician maintained that the
negligence was on the part of the surgical nurses in their
sponge count. A defense verdict was returned for the
It is most likely that in this case the sponge and needle
count was reported correctly, which would account for
the hospital settling the case and allowing the physician
to point to the nurses’
error. Despite counting
procedures, errors still
occur and some studies
have shown that in 62%
Malpractice fears hamper physicianto 88% of cases involving
patient communication, according
a retained foreign object
to a recent study. Read more:
(RFO) the sponge and
needle count is erroneously
reported as correct. Preventing RFOs requires a
multidisciplinary systematic approach (See Stiller RJ,
Tompson T, Ivy MJ. Preventing retained foreign objects
in ob/gyn surgery. Contemporary OB/GYN. 2010;55[6]:
In malpractice cases involving an RFO, the negligence
usually is assumed by the fact that an instrument or
sponge was lef in the patient’s body. Damages and their
MS COLLINS is an attorney specializing in medical malpractice in Long
Beach, California. She welcomes feedback on this column via e-mail to
[email protected]
JULY 2011
monetary value then become the issue. Tese can include
any operation or procedure required to remove the RFO,
an assessment of pain and suffering directly related to the
RFO that have been experienced by the patient, and any
long-term sequelae resulting from the alleged negligence.
In this case, the physician maintained that the patient
would have required surgery for the appendicitis anyway,
and so she did not have an extra operation to support her
claim for damages.
Pulmonary embolism after
cesarean delivery results in death
IN 2005, A 29-YEAR-OLD ILLINOIS WOMAN, pregnant
with twins, had a history of 2 prior cesarean deliveries.
She was hospitalized for 6 days on bed rest because of
preterm contractions. Te patient was discharged home
and subsequently was seen several times at the hospital as
an outpatient.
Tree weeks later she was admitted to the hospital
in labor. A cesarean delivery was performed later that
day. As the delivery was completed, the patient suddenly
became unresponsive and resuscitation attempts were
unsuccessful. An autopsy revealed a massive saddle
pulmonary embolus, which likely had come from a deep
vein thrombus in the legs or pelvis.
A lawsuit was filed and her family testified that the
woman had been told to remain on bed rest whenever
possible at home and that she had done so. Tey alleged
that when bed rest was recommended, the patient should
have been started on deep vein thrombosis prophylaxis
such as thromboembolic deterrent hosiery, sequential
compression devices, and/or heparin.
Te defense maintained that no restrictions had been
placed on the patient’s activity at home, that she had not
been placed on strict bed rest, and that the standard of
care required deep vein thrombosis prophylaxis only for
patients with a prior history of clots or thrombophilia.
Tey argued that the patient had neither medical
condition. Tey also argued that heparin would have
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increased the risk of bleeding and that mechanical
prophylaxes such as thromboembolic deterrent hosiery
and sequential compression devices were not eTective
in preventing pulmonary embolism or death. A defense
verdict was returned.
Woman alleges postpartum
hysterectomy was unnecessary
A 30-YEAR-OLD ILLINOIS WOMAN presented at the
hospital emergency department in 2004 with heavy
vaginal bleeding 12 days afer giving birth to her third
child. She was evaluated by an obstetrician and an
ultrasound was performed. ffe scan found retained
products of conception with pieces of placental tissue
attached to the uterine wall, and a suction dilation
and curettage was performed. ffe patient was given 2
medications to help her uterus to contract in an eTort to
stop the bleeding.
When the bleeding did not slow or stop the
obstetrician called his senior partner for a second
opinion. Both doctors then performed exploratory
surgery to identify the source of the bleeding. ffey
found that the bleeding was diT use throughout the
uterus and that the patient already had lost about
one-third to one-half of her total blood volume.
ffey performed a total abdominal hysterectomy. ffe
patient sued both obstetricians, alleging negligence
in performing the hysterectomy. She argued that in
addition to being unable to have more children, she
suTered chronic pain syndrome as a result of the
ffe physicians claimed that they had acted
appropriately and had saved the woman’s life. A defense
verdict was returned.
Complications from ureter injury
during surgery for pelvic prolapse
A CALIFORNIA WOMAN, 38 years of age, was referred
to a gynecologist in 2008 for severe problems with
urinary stress incontinence and pelvic prolapse. Surgery
was performed using mesh to repair the prolapse, and
included a cystocele repair with bilateral sacrospinous
ligament fi xation and a prepubic transvaginal sling.
Afer the operation the patient suTered pain and
fever. A diagnostic laparoscopy performed the next day
failed to find a suspected bowel perforation; however,
JULY 2011
an intravenous pyelogram revealed a lef ureteral injury.
ffe patient was transferred to another hospital for stent
placement. She developed a vesicovaginal fistula that
included mesh erosion to the bladder.
In her lawsuit against the gynecologist, the patient
claimed that the initial surgery was not indicated and
that conservative treatment should have been tried first.
She also claimed that too many procedures were done
at 1 time, which increased the risk of complications.
She also alleged surgical error and mismanagement of
her postoperative complications. ffe physician claimed
that the surgery was indicated, that the patient had
not been interested in conservative care, and that the
complications she experienced were known risks of the
procedure. A defense verdict was returned.
Failure to diagnose postpartum
breast infection alleged
IN 2007, A MISSOURI WOMAN developed a swollen, tender
area on her right breast almost 3 weeks afer giving
birth. She informed her physician about her condition
and told him that pus was oozing from the nipple. ffe
physician diagnosed a clogged milk duct and prescribed
an antibiotic for her.
Her condition worsened over the next 2 weeks until
milk ceased to flow and her breast became red, painful,
and warm. Her obstetrician prescribed a new antibiotic,
and at her next office visit he told her to let the breast milk
dry up. Within 24 hours of that visit, pus came through
the skin at a point several centimeters above the nipple.
ffe patient went to an emergency room and an abscess
was diagnosed. She underwent surgery during which
100 cc of exudate was removed. ffe infection was caused
by methicillin-resistant Staphylococcus aureus that was
unaTected by the antibiotics prescribed. ffe patient’s
lef breast also was infected; however, it was caught early
enough to be drained with a needle.
ffe patient sued her obstetrician, claiming that the
infection should have been diagnosed earlier and that the
infection could not have grown as quickly as the physician
claimed it had.
ffe physician argued that the infection had developed
afer the patient’s last office visit and that staph infections
are unusual in nursing mothers. He claimed that the
patient had had a clogged milk duct when he saw her and
that the infection developed closer to the time that her
right nipple began oozing pus. A $200,000 verdict was
returned against the obstetrician.
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BSO: Solving the
risk/benefit equation
Choosing candidates, monitoring outcomes
Prophylactic bilateral oophorectomy at the time of hysterectomy confers
long-term health benefits for many women.
Review the Society of
Gynecologic Oncologists’
guidelines on prophylactic BSO
in women at risk for ovarian
cancer: contemporaryobgyn.
ilateral oophorectomy at the time
of hysterectomy for benign disease
has been commonly recommended
to women over the age of 40 or 45 years to
prevent the development of ovarian cancer.
In the United States, at least 300,000 women
annually have bilateral oophorectomy at the
time of hysterectomy: approximately 54% of
all hysterectomy procedures.1 Concomitant
bilateral oophorectomy is most ofen performed in women 50 to 54 years of age. In
this group, 78% of hysterectomies include
bilateral oophorectomy.1
However, prophylactic surgery should be
performed only if there is evidence that it
clearly benefits the patient.2 Recent evidence
suggests that there may be long-term health
benefits and longer survival for women who
choose ovarian conservation at the time of
hysterectomy for benign disease. In addition, oophorectomy improves quality of life
and provides a survival benefit for other
JULY 2011
Ovarian cancer prevention
in women at increased risk
Although the lifetime risk of ovarian cancer is 1.4% overall among US women, the
risk varies by subgroup. For example, white
women at age 65 who have had 3 or more
term pregnancies and at least 4 years of
combined oral contraceptive (OC) use have
a risk of 0.3%, whereas nulliparous women
with the same OC use have a risk of 1.6%.4
Moreover, some women have mutations in
the BRCA1 or BRCA2 gene, and such mutations may disrupt DNA repair mechanisms,
predisposing these women to oncogenesis in
the ovary and breast.5 It appears at present
that no more than 10% of epithelial ovarian cancers are due to inherited mutations
in ovarian cancer-related genes. 6,7 Nevertheless, the lifetime risk of ovarian cancer
among women with these mutations is very
high: for women with BRCA1 mutations the
risk is 36% to 46%, and for BRCA2 mutations the risk is 10% to 27%.8 In addition,
women with the hereditary nonpolyposis
colorectal cancer mutation have a 12% lifetime risk of ovarian cancer.9
For women with BRCA1 and BRCA2 mutations, annual screening for ovarian cancer using transvaginal ultrasound and the
CA125 blood test has not proven efective for
detecting disease early enough to infiuence
survival, and is not recommended.10 ffe only
intervention shown to be efective in reducing the incidence of ovarian cancer in women carrying the BRCA1 or BRCA2 gene mutation is bilateral salpingo-oophorectomy.11 As
a result, authorities agree that women who
have known genetic mutations that increase
the risk of ovarian and breast cancers should
strongly consider oophorectomy afler completion of childbearing.12
About 2% of women have a family history consistent with an increased risk of
ovarian or breast cancer. Recent studies suggest that a large number of low-penetrance
genetic variants account for instances of
women who have a strong family history
but do not have BRCA1 or BRCA2 mutations.13 Genetic counseling from a trained
healthcare provider can help these women
make informed decisions about the advisability of oophorectomy. Removal of the fallopian tubes and ovaries in women with
the BRCA1 or BRCA2 gene mutation reduces the risk of ovarian cancer by 80%.14
Further, a large retrospective study noted a decreased risk of breast cancer during follow-up after unilateral oophorectomy alone or bilateral oophorectomy performed with or without hysterectomy, particularly when these procedures were done
before age 45 years (ratio of observed to expected cases ranging from 0.65 to 0.89).15
Both fallopian tubes also should be removed
at surgery because recent evidence has
shown that most BRCA-related ovarian cancers are actually of tubal origin, beginning
in the epithelial cells of the T mbria of the
fallopian tube.16 ff is T nding also explains
why ultrasound is not effective for cancer
Additionally, some women without a
family or personal history that increases
their risk of ovarian cancer may wish to
have their ovaries removed because of concerns about the possibility of developing
ovarian cancer. If one of these women wishes to proceed with oophorectomy afler a full
discussion of her specific risk for ovarian
and breast cancers and the risks and beneTts of the surgery, I would certainly respect
her wishes.
Risks and side effects
of oophorectomy
Oophorectomy appears to be associated
with long-term health risks. In premenopausal women, oophorectomy immediately
reduces blood levels of ovarian estrogens
and androgens. Even afler menopause, the
ovaries continue to produce significant
amounts of testosterone and androstenedione, which undergo peripheral conversion
to estrone by skin, muscle, and fat cells.17,18
Evidence indicates that endogenous estrogens are beneTcial to the cardiovascular
system and for long-term health and neurologic function.19-22 ffis is a crucial consideration because although ovarian cancer causes
JULY 2011
oophorectomy during
hysterectomy is often
recommended to
prevent development
of ovarian cancer.
surgery should be
recommended only if
it would benefit the
Women with BRCA1/2
or hereditary
nonpolyposis colorectal
cancer mutations are
at increased risk for
breast and ovarian
cancers, and should
consider prophylactic
bilateral salpingooophorectomy.
approximately 15,000 deaths per year in the
US, coronary heart disease (CHD) accounts
for 327,000 deaths per year, 20 and dementia attributable to bilateral oophorectomy
may affect between 100,000 and 200,000
US women.21 For example, a Danish cohort
study found 7 times the risk of ischemic
heart disease in women with a history of
oophorectomy before age 40 years compared
with women having oophorectomy afer age
45 years. fie risk of heart disease increased
with younger age at oophorectomy.22
With regard to neurologic function, a cohort study of premenopausal women undergoing unilateral or bilateral oophorectomy
found that cognitive impairment or dementia occurred in 76 of 813 women (9.3%),
representing nearly a 50% increase in risk.23
Dat a f rom t he Nu rses’ Hea lt h
Study corroborate these findings. During 24 years of follow-up, oophorectomy was associated with increased risks
of death from CHD (hazard ratio [HR],
1.28; 95% confidence interval [CI], 1.001.64) and death from all causes (HR, 1.12;
95% CI, 1.03-1.21). 20 Among women who
had never used estrogen therapy, bilateral oophorectomy before 50 years of
age was associated with increased risks
of all-cause mortality, CHD, and stroke.
Given that the life expectancy after surgery is 35 years, 1 additional death would
be expected for every 9 oophorectomies
performed before age 50. After oophorectomy, women had a markedly reduced
risk of ovarian cancer; however, they had
higher risks of lung cancer (HR, 1.31; 95%
CI, 1.02-1.68) and total cancer mortality (HR, 1.17; 95% CI, 1.04-1.32). Oophorectomy was not associated with increased survival in any analysis or age group. In addition to its effects on CHD risk and cognitive
impairment or dementia, bilateral oophorectomy before the onset of menopause has
been shown to increase the risks of Parkinson disease and anxiety or depression.23-25
Younger age at oophorectomy increased the
risks for these neurologic conditions.
Although a recent analysis of the Women’s Health Initiative (WHI) found that bilateral oophorectomy might not increase
JULY 2011
the risks of cardiovascular disease, cancer, or overall mortality when compared
with ovarian conservation, this study had a
short follow-up (mean, 7.6 years).26 Because
20% of myocardial infarctions occur before
age 65 and women were an average age of
63 years when the WHI enrollment began,
some selection bias cannot be ruled out.
In addition, the premenopausal operations
were self-reported, which means that the
data may be affected by recall bias.
A review of prophylactic oophorectomy
by the Society of Gynecologic Oncologists
Clinical Practice Committee suggested that
ovarian conservation before menopause may
be especially important in patients with a
personal or strong family history of cardiovascular or neurologic disease.27 fie decision
to perform concurrent bilateral salpingooophorectomy in women at average risk of
ovarian cancer therefore should include a
consideration of individual risk factors, such
as family history of cardiovascular and neurologic disease, OC use, parity, and other
epidemiologic factors. 28 Careful preoperative counseling is required, and the decision
should be individualized.
Estrogens and androgens inhibit bone
resorption, and androgens stimulate bone
formation.29 Both premenopausal and postmenopausal women who undergo bilateral
oophorectomy have an increased risk of osteoporosis because of the reduction in hormone levels. Postmenopausal women who
underwent oophorectomy at a median age of
62 years had 54% more osteoporotic fractures
than those with intact ovaries.30 However, 2
other studies found no association of oophorectomy with bone loss or fracture risk.31,32
About 90% of premenopausal women
have vasomotor symptoms after oophorectomy, 33 and many women also experience mood changes, a decline in feelings of
well- being, decreased sexual desire, sleep
disturbances, and headaches. 34-36 Over
time, vaginal dryness, painful intercourse,
bladder dysfunction, and symptoms of depression may occur. 36-38 Although estrogen therapy may reduce some of the increased risks and symptoms that occur afer
oophorectomy, continuation rates of
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• 24-hour urine excretion levels were significantly lower than with Os-Cal® and Caltrate® 1
• 1200 mg of calcium plus 1000 IU of Vitamin D3 in 2 tablets (one dose)
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Caltrate is a registered trademark of Pfizer, Inc.
Reference: 1. Data on file. CITRACAL study. Bayer HealthCare LLC.
© 2011 Bayer HealthCare LLC
January 2011
Risks associated
with oophorectomy,
particularly in younger
women, include heart
disease, cognitive
Parkinson disease, and
In women at average
risk for ovarian cancer,
strategies other
than surgery may be
In women with breast
cancer, oophorectomy
combined with
tamoxifen therapy
has prolonged 10-year
disease-free survival
rates more effectively
than tamoxifen therapy
estrogen therapy are low and new hormone
prescriptions have decreased significantly
over the past decade.39 Likewise, continuation rates for bisphosphonates or statins as
specific therapy for osteoporosis or heart
disease are less than 25% after 1 year.40,41
Critics suggest that medical therapy can
ameliorate all the medical conditions caused
by oophorectomy, but this argument is not
valid because of the poor continuation rates
of these medications. Therefore, medical
treatment for conditions related to estrogen
defciency afier oophorectomy is not likely
to be effective for most women.
Ovarian cancer prevention
for women at average risk
fleoretically, there may be an age at which
the benefits of oophorectomy to prevent
ovarian cancer outweigh the possibility of
increased risks of CHD, neurologic conditions, and overall mortality in low-risk
women. fle incidence of ovarian cancer increases with age, peaking at approximately
75 years. It is likely that with advancing age,
the inTuence of ovarian hormones decreases
compared with that of other known risk
factors for heart disease and other causes
of mortality. A computer modeling study
examined risk data among women with and
without oophorectomy and found that ovarian conservation until at least age 65 years
improved long-term survival for women
who had an average risk of ovarian cancer.42
However, no study has determined the age
at which oophorectomy should be recommended. Endogenous bioavailable testosterone and estrogen in postmenopausal women
are partly protective against the loss of muscle strength that predisposes these women to
falls and against the continuing loss of bone
mineral density that increases the risk of
fractures.43 flerefore, even in older women,
these ovarian hormones may have beneft.
Other strategies may be taken to decrease
the risk of ovarian cancer, including the use
of OC pills or tubal ligation. Taking OCs for
5 or more years decreases the risk of ovarian
cancer by 50%,28 and tubal ligation decreases the risk by 34%.44 Hysterectomy alone decreases the risk of ovarian cancer by 33%.45
JULY 2011
Oophorectomy and breast cancer
A case-control study showed that oophorectomy reduced the risk of breast cancer
by 56% for BRCA1 and 46% for BRCA2 carriers.46 Risk reduction was even greater for
women younger than 40 years at surgery,
and the protective effect persisted 15 years
after surgery. A study of a general Swedish population showed a 50% reduction
in the risk of breast cancer among women
who had bilateral oophorectomy before age
50 years, and this effect was evident within
10 years of the surgery.47
Oophorectomy may be recommended
as treatment for some women with breast
cancer. Although tamoxifen and aromatase inhibitors are typically used to prevent
recurrences of breast cancer in postmenopausal women with estrogen-receptor‒positive, early stage tumors, some investigators
recommend oophorectomy combined with
tamoxifen therapy. flis combination treatment was associated with higher 10-year
disease-free survival than was reported for
women treated with tamoxifen alone.48
In addition, oophorectomy has been used
as treatment for premenopausal women
with metastatic breast cancer, achieving response rates of 14% to 70%, depending on
the study.49 Patients with breast cancer in
clinical remission who are undergoing a
hysterectomy for benign disease may consider concurrent oophorectomy because it
has been associated with a reduction in the
risk of relapse.50
Oophorectomy and endometriosis
Among women with severe, symptomatic
endometriosis unresponsive to conservative management, bilateral oophorectomy
concurrent with hysterectomy decreased
the risks of recurrent or persistent symptoms and the need for reoperation. 51 One
study of women with symptomatic endometriosis compared outcomes between women who had a hysterectomy with ovarian
conser vation and women who had a
hysterectomy with concurrent bilateral
o ophore c tomy. 52 O f t he 29 women
with ovarian conservation, 18 (62%) had
recurrent pain and 9 (31%) required reopera-
tion. Of the 109 women who had both ovaries removed, 11 (10%) had recurrent pain
and 4 (4%) required reoperation. Women
who underwent hysterectomy with ovarian
conservation had 6 times the risk of developing recurrent pain and 8 times the risk of
reoperation compared with women who had
concurrent bilateral oophorectomy.
Another study of confirmed endometriosis found that of the 47 women who had a
hysterectomy with ovarian conservation, 9
(19%) required further surgery.53 Te 2-, 5-,
and 7-year reoperation rates were 4%, 13%,
and 23%, respectively. Of the 50 women who
had a hysterectomy with bilateral oophorectomy, only 4 (8%) required reoperation,
with reoperation rates of 4% at 2 years, 8%
at 5 years, and 8% at 7 years. Preservation of
both ovaries doubled the risk of reoperation
regardless of the patient’s age. Te authors
concluded that local excision of endometriosis is associated with good short-term
outcomes but has a high reoperation rate,
whereas hysterectomy with bilateral salpingo-oophorectomy has a low reoperation rate.
In contrast, an analysis of women younger than 40 years with advanced endometriosis found that the time to repeat surgery was
the same whether the ovaries were removed
or conserved. Given the problems associated
with early menopause, the authors recommended that for women younger than 40
years of age, hysterectomy with ovarian conservation should be considered.53
Avoiding future adnexal surgery
Te percentage of women who require reoperation after hysterectomy with ovarian conservation is low, with residual ovary
syndrome occurring at a rate of approximately 2.8%. 54 Asymptomatic cystic ovarian tumors are relatively prevalent (6.6%)
in postmenopausal women. 55 These cysts
do not undergo transformation to cancer,
however, and in most cases do not need to
be removed. Another study reported that
only 0.75% of women developed ovarian
cancer afer hysterectomy and ovarian conservation performed by the vaginal or abdominal route.56 Performing oophorectomy
to avoid future surgery appears unfounded.
Medical decisions involve a balance of benefits and risks for each individual patient.
Prophylactic surgery should be performed
only if the weight of the evidence establishes that it clearly benefits the patient. Undoubtedly, bilateral salpingo-oophorectomy
is advisable for women who have a high
risk of ovarian and breast cancer because of
gene mutations. In addition, women older
than 40 years with severe endometriosis
unresponsive to conservative treatment
may benefit from oophorectomy.
The decision about oophorectomy
for other women is problematic, and
more research will be needed to answer
the remaining clinical questions. Unfortunately, the entire body of evidence
that examines the risks and benefits of
bilateral salpingo-oophorectomy is derived from observational studies, which
have significant inherent limitations. At
a minimum, gynecologists should provide detailed informed consent covering
the risks and benefits of both oophorectomy and ovarian conservation.
In women with
oophorectomy during
hysterectomy has
reduced system
recurrence and need
for repeat surgery.
DR PARKER is on the adjunct faculty of the John Wayne Cancer
Institute at St John’s Health Center and in private practice in Santa
Monica, California. He reports no real or apparent conflicts of interest
with respect to the content of this article.
1. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient
hysterectomy surveillance in the United States, 2000-2004.
Am J Obstet Gynecol. 2008;198(1):34.e1-34.e7.
2. Asante A, Whiteman MK, Kulkarni A, Cox S, Marchbanks
PA, Jamieson DJ. Elective oophorectomy in the United
States: trends and in-hospital complications, 1998-2006.
Obstet Gynecol. 2010;116(5):1088-1095.
3. Hickey M, Ambekar M, Hammond I. Should the ovaries be
removed or retained at the time of hysterectomy for benign
disease? Hum Reprod Update. 2010;16(2):131-141.
4. Hartge P, Whittemore AS, Itnyre J, McGowan L, Cramer
D; the Collaborative Ovarian Cancer Group. Rates and risks
of ovarian cancer in subgroups of white women in the United
States. Obstet Gynecol. 1994;84(5):760-764.
5. Tutt A, Ashworth A. The relationship between the roles
of BRCA genes in DNA repair and cancer predisposition.
Trends Mol Med. 2002;8(12):571-576.
6. Stratton JF, Gayther SA, Russell P, et al. Contribution
of BRCA1 mutations to ovarian cancer. N Engl J Med.
JULY 2011
7. Tinelli A, Malvasi A, Leo G, et al. Hereditary ovarian
cancers: from BRCA mutations to clinical management. A
modern appraisal. Cancer Metastasis Rev. 2010;29(2):
8. Rebbeck TR, Kauff ND, Domchek SM. Meta-analysis
of risk reduction estimates associated with risk-reducing
salpingo-oophorectomy in BRCA1 or BRCA2 mutation
carriers. J Natl Cancer Inst. 2009;101(2):80-87.
9. Schmeler KM, Lu KH. Gynecologic cancers associated
with Lynch syndrome/HNPCC. Clin Transl Oncol.
10. Evans DG, Gaarenstroom KN, Stirling D, et al. Screening
for familial ovarian cancer: poor survival of BRCA1/2 related
cancers. J Med Genet. 2009;46(9):593-597.
11. Kauff ND, Domchek SM, Friebel TM, et al. Riskreducing salpingo-oophorectomy for the prevention of
BRCA1- and BRCA2-associated breast and gynecologic
cancer: a multicenter, prospective study. J Clin Oncol.
12. Armstrong K, Schwartz JS, Randall T, Rubin SC,
Weber B. Hormone replacement therapy and life
expectancy after prophylactic oophorectomy in women
with BRCA1/2 mutations: a decision analysis. J Clin Oncol.
13. Mackay J, Szecsei CM. Genetic counseling for hereditary
predisposition to ovarian and breast cancer. Ann Oncol.
2010;21(Suppl 7):vii334-vii338.
14. Finch A, Beiner M, Lubinski J, et al; Hereditary Ovarian
Cancer Clinical Study Group. Salpingo-oophorectomy and
the risk of ovarian, fallopian tube, and peritoneal cancers
in women with a BRCA1 or BRCA2 mutation. JAMA.
24. Rocca WA, Bower JH, Maraganore DM, et al. Increased
risk of parkinsonism in women who underwent oophorectomy
before menopause. Neurology. 2008;70(3):200-209.
25. Rocca WA, Grossardt BR, Geda YE, et al. Long-term
risk of depressive and anxiety symptoms after early bilateral
oophorectomy. Menopause. 2008;15(6):1050-1059.
26. Jacoby VL, Grady D, Wactawski-Wende J, et al.
Oophorectomy vs ovarian conservation with hysterectomy:
cardiovascular disease, hip fracture, and cancer in the
Women’s Health Initiative Observational Study. Arch Intern
Med. 2011;171(8):760-768.
27. Berek JS, Chalas E, Edelson M, et al; Society of
Gynecologic Oncologists Clinical Practice Committee.
Prophylactic and risk-reducing bilateral salpingooophorectomy: recommendations based on risk of ovarian
cancer. Obstet Gynecol. 2010;116(3):733-743.
28. Riman T, Nilsson S, Persson IR. Review of
epidemiological evidence for reproductive and hormonal
factors in relation to the risk of epithelial ovarian
malignancies. Acta Obstet Gynecol Scand. 2004;83(9):
29. Raisz LG, Wiita B, Artis A, et al. Comparison of the
effects of estrogen alone and estrogen plus androgen on
biochemical markers of bone formation and resorption
in postmenopausal women. J Clin Endocrinol Metab.
30. Melton LJ 3rd, Khosla S, Malkasian GD, Achenbach SJ,
Oberg AL, Riggs BL. Fracture risk after bilateral
oophorectomy in elderly women. J Bone Miner Res.
15. Kreiger N, Sloan M, Cotterchio M, Kirsh V. The risk of
breast cancer following reproductive surgery. Eur J Cancer.
31. Kritz-Silverstein D, von Mühlen DG, Barrett-Connor E.
Hysterectomy and oophorectomy are unrelated to bone loss
in older women. Maturitas. 2004;47(1):61-69.
16. Callahan MJ, Crum CP, Medeiros F, et al. Primary
fallopian tube malignancies in BRCA-positive women
undergoing surgery for ovarian cancer risk reduction. J Clin
Oncol. 2007;25(25):3985-3990.
32. Antoniucci DM, Sellmeyer DE, Cauley JA, et al; Study of
Osteoporotic Fractures Research Group. Postmenopausal
bilateral oophorectomy is not associated with increased
fracture risk in older women. J Bone Miner Res.
17. Judd HL, Judd GE, Lucas WE, Yen SS. Endocrine
function of the postmenopausal ovary: concentration of
androgens and estrogens in ovarian and peripheral vein
blood. J Clin Endocrinol Metab. 1974;39(6):1020-1024.
18. Fogle RH, Stanczyk FZ, Zhang X, Paulson RJ. Ovarian
androgen production in postmenopausal women. J Clin
Endocrinol Metab. 2007;92(8):3040-3043.
19. Colditz GA, Willett WC, Stampfer MJ, Rosner B, Speizer
FE, Hennekens CH. Menopause and the risk of coronary
heart disease in women. N Engl J Med. 1987;316(18):
20. Parker WH, Broder MS, Chang E, et al. Ovarian
conservation at the time of hysterectomy and long-term
health outcomes in the Nurses’ Health Study. Obstet
Gynecol. 2009;113(5):1027-1037.
21. Bennett DA. Editorial comment on ‘Prevalence of
dementia in the United States: the Aging, Demographics,
and Memory Study’ by Plassman et al. Neuroepidemiology.
22. Løkkegaard E, Jovanovic Z, Heitmann BL, Keiding N,
Ottesen B, Pedersen AT. The association between early
menopause and risk of ischaemic heart disease: influence of
hormone therapy. Maturitas. 2006;53(2):226-233.
23. Rocca WA, Bower JH, Maraganore DM, et al. Increased
risk of cognitive impairment or dementia in women who
underwent oophorectomy before menopause. Neurology.
JULY 2011
33. Hansen KA. Female reproductive biology. In: O’Leary JP,
Tabuenca A, Capote LR (eds). The Physiologic Basis of
Surgery, 4th ed. Philadelphia, Pennsylvania: Lippincott
Williams & Wilkins; 2007:314-315.
34. Nathorst-Böös J, von Schoultz B, Carlström K. Elective
ovarian removal and estrogen replacement therapy--effects
on sexual life, psychological well-being and androgen status.
J Psychosom Obstet Gynaecol. 1993;14(4):283-293.
35. Elit L, Esplen MJ, Butler K, Narod S. Quality of life and
psychosexual adjustment after prophylactic oophorectomy
for a family history of ovarian cancer. Fam Cancer. 2001;
36. Taylor M. Psychological consequences of surgical
menopause. J Reprod Med. 2001;46(3 Suppl):317-324.
37. Bachmann GA, Nevadunsky NS. Diagnosis and
treatment of atrophic vaginitis. Am Fam Physician.
38. Shifren JL, Avis NE. Surgical menopause: effects
on psychological well-being and sexuality. Menopause.
2007;14(3 Pt 2):586-591.
39. Wegienka G, Havstad S, Kelsey JL. Menopausal hormone
therapy in a health maintenance organization before and after
Women’s Health Initiative hormone trials termination.
J Womens Health (Larchmt). 2006;15(4):369-378.
40. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J.
Compliance with drug therapies for the treatment and
prevention of osteoporosis. Maturitas. 2004;48(3):271-287.
adjuvant oophorectomy and tamoxifen in operable
breast cancer in premenopausal women. J Clin Oncol.
41. Huser MA, Evans TS, Berger V. Medication adherence
trends with statins. Adv Ther. 2005;22(2):163-171.
49. Prowell TM, Davidson NE. What is the role of ovarian
ablation in the management of primary and metastatic breast
cancer today? Oncologist. 2004;9(5):507-517.
42. Parker WH, Broder MS, Liu Z, Shoupe D, Farquhar C,
Berek JS. Ovarian conservation at the time of hysterectomy
for benign disease. Obstet Gynecol. 2005;106(2):219-226.
43. van Geel TA, Geusens PP, Winkens B, Sels JP,
Dinant GJ. Measures of bioavailable serum testosterone and
estradiol and their relationships with muscle mass, muscle
strength and bone mineral density in postmenopausal
women: a cross-sectional study. Eur J Endocrinol.
44. Cibula D, Widschwendter M, Májek O, Dusek L. Tubal
ligation and the risk of ovarian cancer: review and metaanalysis. Hum Reprod Update. 2011;17(1):55-67.
45. Hankinson SE, Hunter DJ, Colditz GA, et al. Tubal
ligation, hysterectomy, and risk of ovarian cancer. A
prospective study. JAMA. 1993;270(23):2813-2818.
46. Eisen A, Lubinski J, Klijn J, et al. Breast cancer risk
following bilateral oophorectomy in BRCA1 and BRCA2
mutation carriers: an international case-control study. J Clin
Oncol. 2005;23(30):7491-7496.
47. Schairer C, Persson I, Falkeborn M, Naessen T, Troisi R,
Brinton LA. Breast cancer risk associated with gynecologic
surgery and indications for such surgery. Int J Cancer.
48. Love RR, Van Dinh N, Quy TT, et al. Survival after
50. Kelsey JL, Bernstein L. Epidemiology and prevention of
breast cancer. Annu Rev Public Health. 1996;17:47-67.
51. Vercellini P, Barbara G, Abbiati A, Somigliana E, Viganò P,
Fedele L. Repetitive surgery for recurrent symptomatic
endometriosis: what to do? Eur J Obstet Gynecol Reprod Biol.
52. Namnoum AB, Hickman TN, Goodman SB,
Gehlbach DL, Rock JA. Incidence of symptom recurrence
after hysterectomy for endometriosis. Fertil Steril.
53. Shakiba K, Bena JF, McGill KM, Minger J, Falcone T.
Surgical treatment of endometriosis: a 7-year follow-up
on the requirement for further surgery. Obstet Gynecol.
54. Dekel A, Efrat Z, Orvieto R, et al. The residual ovary
syndrome: a 20-year experience. Eur J Obstet Gynecol
Reprod Biol. 1996;68(1-2):159-164.
55. Bailey CL, Ueland FR, Land GL, et al. The malignant
potential of small cystic ovarian tumors in women over 50
years of age. Gynecol Oncol. 1998;69(1):3-7.
56. Naylor AC. Hysterectomy—analysis of 2901 personally
performed procedures. S Afr Med J. 1984;65(7):242-245.
The 1st & Only FDA Cleared Blood Test for Pre-Surgical Evaluation of Ovarian Masses
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t OVA1 improved overall Sensitivity (95.7%) and NPV (94.6%) when
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t OVA1 is available nationwide exclusively through Quest Diagnostics.
*FDA clearance does not denote official approval. 1OVA1 product insert. OVA1® is a qualitative serum test that combines the results
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Is “progress” good for your practice?
ince World War II, evidence-based medicine
has rapidly replaced custom and lore.
Proliferation of imaging and laboratory
studies has improved diagnostic accuracy. Drugs and
other treatments have vastly improved our ability
to cure and alleviate disease. For example, survival
rates for common kinds of cancer improved from
27% to 550% between the 1950s and the 1990s.1 But
interestingly, as physicians’
effectiveness has increased,
their satisfaction with
their profession has
diminished 2:
A recent
In 1973, less than
15% of several thousand
survey shows
practicing physicians
many are
reported any doubts that
they had made the correct
career choice. In contrast,
Read more
surveys administered
within the past 10 years
have shown that 30% to
40% of practicing physicians would not choose to
enter the medical profession if they were deciding on
a career again, and an even higher percentage would
not encourage their children to pursue a medical
career. In a telephone survey of 2,000 physicians that
was conducted in 1995, 40% of the doctors said they
CCLINICIAN TO CLINICIAN offers the hard-won
and expertise of physicians “in the trenches.”
W looking for unusual case reports, anecdotes
about innovative treatments, and practical solutions for professional problems from
community physicians.
Send your submission of 750 words or less to Patricia M. Fernberg, Editor, by
e-mail ([email protected]). All submissions are subject to peer review by the
Contemporary OB/GYN Editorial Advisory Board. Nevertheless, the concepts discussed
may be anecdotal in nature.
JULY 2011
would not recommend the profession of medicine to a
qualified college student.
In a national survey in 1981, 48% of 1,426 officebased doctors said they would not recommend the
practice of medicine as highly as they would have
10 years earlier. In a follow-up survey in 2001, 58%
of 2,608 physicians said that their enthusiasm for
medicine had declined in the previous 5 years, and
87% said that the overall morale of physicians had
declined during that time.
Massachusetts physicians who were asked in 2001
to recall their thoughts about medical practice 5 years
earlier reported more current dissatisfaction with
virtually all aspects of practice, including income,
workload, and time consumed by administrative tasks.
Among California physicians questioned in 1991
and again in 1996, the percentage who said they were
less than fully satisfied with the practice of medicine
rose from 53% to 63%. (Internal references omitted.)
Te ultimate cause of physician dissatisfaction is
the very phenomenon that has led to the success of
medicine. Te change of medicine from a craf to an
applied science has prompted changes in the nature of
the work and the relationships of physicians with all
relevant elements of society. T is, in turn, has spurred
a decline in income, an increase in managed care, 3
and a rise in malpractice suits.
Objective knowledge leads to best practices,
which, in turn, leads to well-defi ned standards.
Physicians who comply with standards will do things
in the same way and will have similar capabilities.
T is makes them roughly interchangeable. T is is
called industrialization. Industrialization allows
organizations and payors to standardize medical roles
and enforce standard rules, including practice modes
and compensation. T is is called bureaucratization.
Tese 2 phenomena leave physicians with little
Although science has produced new and improved procedures and pharmaceuticals that
allow us to better treat patients, the byproducts of industrialization and bureaucratization
diminish our status, job satisfaction, and income. Is there a happy medium?
The change of medicine from a craft to an applied science has
prompted changes in the nature of the work and the relationships
of physicians with all relevant elements of society.
leverage vis-à-vis payors, patients, government,
and hospitals, which in turn decreases extrinsic
satisfaction with the ffield.
fie practice of medicine now also provides less
intrinsic satisfaction. Standardization of practice
makes medicine less creative. Furthermore, success is
expected, and poor clinical results represent failure.
Physicians are not heroes when successful, but are
blamed for lack of success. Most feel the pressured by
insurance companies to herd patients in and out of the
door, push forms, and punch time clocks.
A visit to a physician used to cost about $10 in the 1950s,
but some physicians charged more than $1,000 for the
service. Today no physician’s service commands 100
times that of another’s.
Professionals in other ffields with unusual skills
command vast amounts of money and respect. For
every Andre Agassi or Meryl Streep, there are millions
of weekend tennis players and amateur actors who are
unable to make a living from their respective craTs.
Partly for this reason, people with prized skills become
known as artists. Artisans also vary in skill and in
compensation, although not as much as artists.
Industrial workers, on the other hand, have jobs
with standardized outcomes that generally cannot
be exceeded. fiey are supposed to perform a task
correctly almost all of the time. fiis is possible because
management has standardized and simpliffied the work.
Finally, other jobs, such as that of a bank teller, are
easy enough that a person provided minimal training
will rarely make mistakes.
When products and services arise from tasks and
skills rather than from art and craT, a greater quantity
of work output becomes possible, the products become
less expensive, and the quality of the product becomes
more consistent. For example, as the production of
goods, such as guns and cloth, became industrialized in
the early 19th century, prices fell and quality improved.
Because there are more consumers of any product than
there are producers, society welcomes industrialization.
fie down side is that industrialization decreases a
worker’s intrinsic and extrinsic satisfaction with his
or her work. When work quality varies, workers enjoy
a greater degree of independence because clients and
employers seek workers with unique or uncommon
skills to accommodate their individual preferences.
Furthermore, remuneration decreases as work
becomes more reproducible. Similarly, the diference
in value between excellent and average work decreases
as work becomes standardized. fie best athletes and
actors earn many times more money than average
ones, while the best and the worst clerks earn
relatively the same. Any diferences in salary are not
based on ability or
performance but on
factors unrelated to
the job itself, such as
seniority or location.
satisfaction with work
also declines with
Reproducibility of
work minimizes
judgment and
creativity and
increases boredom.
It becomes easy to err and hard to excel. Industrial
workers cannot do more than to perform a task
correctly, but they can fail to do this. One either
installs the widget correctly or errs. Clearly, avoiding
failure provides less satisfaction than does striving for
decreases a
worker’s intrinsic
and extrinsic
satisfaction with
his or her work.
The industrialization of medicine
Physicians’ work is becoming industrialized.
Prevention, diagnosis, and treatment of disease
all have become more precise and standardized,
and much more of medicine is governed by rules,
guidelines, and procedures.
At one time, physicians difered greatly in their
abilities to take histories, perform examinations,
and make clinical decisions. Surgeons varied in their
ability to operate safely on patients. In a teaching
JULY 2011
setting, citation of the practices of respected local
clinicians was as acceptable as citation of literature.
For at least the last 50 years, however, tests and
treatments have become objectified and simplified.
In the 1970s, for example, obstetricians estimated
date of delivery (EDD) using the history and physical
examination, which frequently confl icted. Tey then
had to use judgment to decide which factors to accept
to establish EDD. Now early ultrasound accurately
fi xes the EDD.
Similarly, obstetricians monitored for fetal distress
during labor with intermittent auscultation. A good
or lucky physician might perceive subtle slowing of
the fetal heart rate. Now we need only view monitor
strips to determine the fetus’s well-being. Where
once the management of obstetric complications
required experience and superior judgment, now
nationally accepted standards govern treatment of
such problems as hypertension and streptococcal
infection. Obstetricians now consult perinatologists
about problems to
which guidelines do
not readily apply. One
not-so-fringe benefit is
that preventable causes
of fetal mortality
decreased by 65%
between 1965 to 1990. 5
Te practice of
gynecology also has
undergone division of
labor, standardization,
and simplification.
Treatment of
infertility and cancer now largely is handled by
certified subspecialists. Generalists’ surgery has
become simpler. For example, sterilization now
is accomplished via hysteroscopic tubal occlusion
instead of by vaginal hysterectomy or vaginal tubal
ligation. New operative techniques, such as stapling
and electrosurgery, have made old operations easier
and safer.
Guidelines for standard of care have proliferated.
By 2010, the American College of Obstetricians and
Gynecologists (ACOG) had adopted at least 67 clinical
Committee Opinions or Practice Recommendations.
Individual institutions have adopted many others.
Other medical fields reveal comparable fi ndings.
Coronary bypass requires delicate, rapid, and
It is extremely
difficult for
physicians to
obtain privileges
for new
accurate anastomosis of blood vessels. If differences
in physicians’ skill influenced clinical results, they
surely would for this procedure. Between 2006 and
2008, however, 122 physicians in New York performed
at least 50 coronary bypass procedures. Only 7 of
these surgeons had mortality rates statistically better
or worse than the overall statewide rate of 1.81%. 5 At
a significance level of P<0.05, one would expect that
6 surgeons would be outliers if no one actually was
better or worse than another. Te results indicate
that almost any heart surgeon can perform coronary
bypass as safely as any other, making heart surgeons
virtually interchangeable to employers and payors.
Researchers have found similar results among other
kinds of surgeons.6,7
Preventive care and treatment of relatively
minor common conditions are highly subject to
standardization. For example, hospitals report
achieving greater than 90% compliance with Surgical
Care Improvement Project (SCIP) guidelines.8 Te use
of audits9 and computerized records10,11 has enhanced
enforcement of these guidelines. Compliance
decreases surgical infection rates, but guidelines
restrict physicians’ judgment. Physicians can err, but
they cannot exceed the standard.
In the 1960s, a group of gynecologists in the United
States integrated intestinal and urinary surgery
and the administration of chemotherapy into their
treatment of patients with cancer. Tey thus created
the subspecialty of gynecologic oncology, improving
the cure rate and safety for women with gynecologic
cancer. No hospital now would now allow physicians to
expand the scope of their practice the way these pioneers
did. Hospitals define privileges precisely and award them
to strictly defined categories of physicians. It is extremely
difficult for physicians to obtain privileges for new
Weber12 described bureaucratization as work
governed by well-defi ned roles, with rules governing
those roles. Rules dictate how workers must perform,
how their work is monitored, and how they are
compensated. In medicine, such rules are provided
by licensure, certification, and credentialing, and by
hospital and government laws, rules, and regulations.
Increasingly, medical care is managed and dictated
by algorithms produced by insurance companies and
administered by clerks without healthcare training.
continued on page 34
JULY 2011
Christian Pettker, MD, lead author of a
major patient safety study, performs an
ultrasound on a patient.
Yale-New Haven Hospital doctors and nurses
conducted a four-year patient safety study that
led to a 40 percent decrease in the hospital’s
obstetrical adverse events. Their interventions
included team training for hospital staff,
standardizing interpretation of fetal monitoring,
improved communication between staff and
creating the role of patient safety nurse. While
interventions of this sort involve fundamental
culture change, commitment and persistence,
Breaking new ground
in the advancement
of patient safety
the improved outcomes proved that the hard
work paid off. In addition to positive results that
continue to this day, the program’s pioneering
work recently led to an Award of Research
Excellence from the Society for Maternal-Fetal
Medicine. Our efforts are not only changing how
we care for patients at Yale-New Haven, but
they are leading the way in the obstetrical patient
safety movement across the country.
Yale-New Haven Hospital is the primary teaching
hospital of Yale School of Medicine. Gynecology
services at Yale-New Haven were ranked 15th by
U.S.News & World Report in 2010-11.
DHA plus iodine and biotin!
Nothing is too good for
her little prince
> 150 mcg of iodine to compensate for the general reduction in iodine
status in the USA1*
> Severe iodine deficiency during pregnancy has been shown to
lead to mental retardation and other developmental abnormalities
in infants2
> 250 mcg of biotin to maintain levels during pregnancy3
> 300 mg of DHA may help to improve cognitive development and
visual acuity4-7†
> The Prenate® Vitamin Family contains Metafolin®, which may help
reduce the risk of neural tube defects, especially in those who have
difficulty metabolizing folic acid8-10
Learn more at and
* The NHANES I and NHANES III surveys showed that from 1988-1994, 11.7% of Americans exhibited iodine deficiency, which represents a 4.5-fold
increase compared with 1971-1974.1
Supportive, but not conclusive, research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.
One capsule of PRENATE ESSENTIAL™ provides 340 mg of omega-3 fatty acids, of which 300 mg are DHA.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep
this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have
potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration
of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or
acquired predisposition to bleeding.
Please see full Product Information on reverse.
With them all the way
DESCRIPTION: PRENATE ESSENTIAL™ is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel
is blue-green in color, opaque, and imprinted with “Prenate” on one side.
Vitamin C
85 mg
Vitamin D3
200 IU
Vitamin E
10 IU
Vitamin B6
25 mg
1 mg
(L-methylfolate as Metafolin 600 mcg)
(folic acid, USP 400mcg)
12 mcg
Vitamin B12
250 mcg
140 mg
(calcium carbonate)
28 mg
Iron (ferrous fumarate)
Iodine (potassium iodide) 150 mcg
45 mg
(magnesium oxide)
Docosahexaenoic Acid (DHA) 300 mg
Eicosapentaenoic Acid (EPA) 40 mg
(from 340 mg omega-3 fatty acids from fish oil)
Other Ingredients: fish oil, gelatin, hydrogenated vegetable oil, glycerin, sorbitol, beeswax, soy lecithin, titanium dioxide, vanillin, FD&C
blue No. 1, propylene glycol, hypromellose.
Have your say about
what appears in
INDICATIONS: PRENATE ESSENTIAL is a multivitamin/mineral/essential fatty acid nutritional supplement indicated for use in improving
the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PRENATE
ESSENTIAL can also be beneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS: PRENATE ESSENTIAL is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic
effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be
avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product
out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Would you like to join our
panel of Clinical Reactors?
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin
B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while
neurological manifestations progress.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during, and/or after pregnancy, one softgel daily or as directed by a physician.
HOW SUPPLIED: Unit-dose packs of 30 softgels
NDC # 59630-419-30
Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).
[See USP Controlled Room Temperature]
For inquiries call 1-800-849-9707 extension 1454.
U.S. Patents #5,997,915; #6,254,904; #6,011,040; #6,451,360; #6,673,381; #6,808,725; #6,441,168
Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany.
PNE-PI-1 Rev. 02/10
Manufactured for:
Manufactured by:
Catalent Pharma Solutions, Swindon, UK
Made in the United Kingdom
Atlanta, Georgia USA 30328
References: 1. Hollowell JG, Staehling NW, Hannon WH, et al. Iodine nutrition in the United States. Trends and public health implications:
iodine excretion data from National Health and Nutrition Examination Surveys I and III (1971-1974 and 1988-1994). J Clin Endocrinol
Metab. 1998;83(10):3401-3408. 2. Zimmermann MB. Iodine deficiency. Endocr Rev. 2009;30(4):376-408. 3. Mock DM. Marginal biotin
deficiency is common in normal human pregnancy and is highly teratogenic in mice. J Nutr. 2009;139(1):154-157. 4. Horrocks LA, Yeo
YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res.1999;40(3):211-225. 5. Uauy R, Hoffman DR, Mena P, Llanos A,
Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr.
2003;143(suppl 4):S17-S25. 6. Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of
long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42(3):174-181. 7. Agostoni
C, Trojan S, Bellù R, Riva E, Giovannini M. Neurodevelopmental quotient of healthy term infants at 4 months and feeding practice: the role
of long-chain polyunsaturated fatty acids. Pediatr Res. 1995;38(2):262-266. 8. Dietary supplement fact sheet: folate. National Institutes
of Health Web site. Accessed March 15, 2010. 9. March of Dimes® Quick Reference. Folic acid.
March of Dimes® Web site. Accessed March 15, 2010. 10. Metafolin®:
about Metafolin®. Merck KGaA Web site. Accessed March 15, 2010.
Prenate® is a registered trademark and Prenate Essential™ is a trademark of Shionogi Pharma, Inc.
Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany.
© 2010 Shionogi Pharma, Inc. Atlanta, Georgia. All rights reserved. PRE.
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continued from page 30
Rules also govern billing and payment. Payment
schedules are linked to procedure codes, which
physicians must link to appropriate diagnoses. Errors
can subject physicians to fi nes and criminal action.
Te 2011 Current Procedural Terminology manual
is 630 pages. Te International Classification of
Diseases Ninth Revision (ICD-9) is even longer. Rules
governing hospital practice and payment are still more
The consequences
In the end, it is increasingly difficult for physicians
to manage practices that comply with payors’ and
regulators’ requirements. Because institutions must
do this, they must exert control over physicians’
practice patterns. In 2004, 65.5% of physicians
were self-employed, 8.4% were employed by other
physicians, and 26.1% were employed by institutions.13
Near eradication of private practice seems inevitable.
Medical industrialization and bureaucratization
will continue as technology advances, regardless
of how medical care is financed. Although more
illnesses will yield to accurate diagnosis and effective,
standardized treatment, physicians will become less
creative, will use
less judgment in
practice, and will
alter their focus
from the pursuit
of excellence to
the avoidance of
Physicians are
losing importance
and standing
in the eyes of
patients, hospitals,
employers, and
payors. For example, most patients will switch
from a physician with whom they have had a longstanding relationship to a new one if the former is
out-of-network and costs more. Thus, physicians’
interchangeability also reduces their income. Between
1995 and 2003, physicians’ income fell by 7%,
adjusting for inflation.14
Most physicians soon will be employees of large
organizations in which they are not shareholders.
Although this would be inevitable even without
government involvement, the government is aware
of the potential of large groups to control costs and
The chief
attribute that
will differentiate
clinicians moving
forward will be
interpersonal skills.
JULY 2011
possibly quality, and is spurring the shift with the
Patient Protection and Affordable Care Act of 2010,
which will force physicians into accountable care
Electronic medical records (EMR) will incorporate
care algorithms, which will direct compliance. They
will prompt physicians to obtain certain information
or to employ certain treatments. EMRs will be
necessary to cope with requirements of regulators and
payors. Such sophisticated EMRs may be beyond the
financial reach of independent physicians, providing
another impetus for them to become employees.
High-level cognitive skills, such as creativity
and judgment, will be reserved for use in research
positions. Only a small number of elite schools will
train medical leaders, while the others will train
clinicians. Medical leaders will be minimally involved
in patient care.
Clinicians will view their work as a livelihood
rather than as a career. They already are more
inclined to choose medical specialties that offer short,
controllable work hours.15 Highly ambitious people
who are willing to invest long hours for the possibility
of great reward will enter alternative professions
such as investment banking, law, or computer science
rather than clinical medicine.
Physicians will increasingly regard themselves as
workers rather than professionals. The American
Medical Association has cautiously endorsed
physicians’ unions, preferring the term “independent
bargaining units.”16 Physician strikes may occur here,
as they have abroad17-19, and their political views likely
will continue to move to the left. 20
The one way in which physicians can continue to
vary is in their ability to attract patients and persuade
them to follow treatment plans. In other words,
the chief attribute that will differentiate clinicians
moving forward will be interpersonal skills. Perhaps,
if nothing else, this inevitable climactic shift in
medicine will improve bedside manner.
DR JACOBS is chair, obstetrics and gynecology, Flushing Hospital
Medical Center, Flushing, New York; professor, obstetrics, gynecology,
and reproductive medicine, and affiliated faculty, Center for Medical
Humanities, Compassionate Care and Bioethics, Stony Brook University
School of Medicine, Stony Brook, New York. He has no conflicts of interest,
real or apparent, with regard to the content of this article.
The opinions expressed in this article are those of Dr Jacobs, and do not
reflect the opinions of the institutions with which he is affiliated or those of
the publishers and editors of Contemporary OB/GYN.
Don’t Miss
A Single Issue.
1. National Cancer Institute. SEER Cancer Statistics Review 1973-1999.
Health/2002/SEER-Cancer1950-99.htm. Accessed June 17, 2011.
2. Zuger A. Dissatisfaction with medical practice. N Engl J Med. 2004;350(1):69-75.
3. Hadley J, Mitchell JM. Efffects of HMO market penetration on physicians’ work effort and
satisfaction. Health Aff (Millwood). 1997;16(6):99-111.
Translating Science into Sound Clinical Practice
New techniques
for treating
5. Percutaneous coronary interventions (PCI) in New York State 2006-2008. New York State
Department of Health Web site.
pci_2006-2008.pdf. Published December 2010. Accessed June 15, 2011.
6. Copeland GP, Sagar P, Brennan J, et al. Risk-adjusted analysis of surgeon performance: a 1-year
study. Br J Surg. 1995;82(3):408-411.
9. Jamtvedt G, Young JM, Kristoffersen DT, Thomson O’Brien MA, Oxman AD. Audit and feedback:
effects on professional practice and health care outcomes. Cochrane Database Syst Rev.
10. East J, Krishnamurthy P, Freed B, Nosovitski G. Impact of a diabetes electronic management
system on patient care in a community clinic. Am J Med Qual. 2003;18(4):150-154.
11. Tung Y, Duffy LC, Gyamfi JO, et al. Improvements in immunization compliance using a
computerized tracking system for inner city clinics. Clin Pediatr (Phila). 2003;42(7):603-611.
12. Weber M. Economy and Society. Roth G, Wittich C, eds. Berkeley, CA: University of California
Press; 1978:956-962.
13. Kane CK; American Medical Association Center for Health Policy Research. Physician
marketplace report.
Published February 2004. Accessed June 15, 2011.
14. Tu HT, Ginsburg PB. Losing ground: physician income, 1995–2003. Center for Studying Health
System Change. Tracking Report No. 15. Published
June 2006. Accessed June 21, 2011.
15. Dorsey ER, Jarjoura D, Rutecki GW. Influence of controllable lifestyle on recent trends in specialty
choice by US medical students. JAMA. 2003;290(9):1173-1178.
16. Greenhouse S. Angered by H.M.O.’s treatment, more doctors are joining unions. The New York
Times. February 4, 1999:A1.
CDC’s new strep B
guidelines PAGE 6
Genes determine
severe morning
sickness sufferers PAGE 10
7. Sommer F, Ehsan A, Klotz T, Haupt G, Caspers H-P, Engelmann U. Comparison of individual
urologists’ performance. Eur Urol. 2001;39(4):369-374.
8. Berenguer CM, Ochsner MG Jr, Lord SA, Senkowski CK. Improving surgical site infections: using
National Surgical Quality Improvement Program data to institute Surgical Care Improvement Project
protocols in improving surgical outcomes. J Am Coll Surg. 2010;210(5):737-741, 741-743.
4. Singh GK, Yu SM. Infant mortality in the United States: trends, differentials, and projections, 1950
through 2010. Am J Pub Health. 1995;85(7):957-964.
Are infants born under
midwife care at higher
risk for death? PAGE 14
“Contemporary OB/GYN is
packed with critical, useful
information that OB/GYNs can
use to improve their practices,
even save lives.”
17. Baer N. Despite some PR fallout, proponents say MD walkouts increase awareness and may
improve health care. Can Med Assoc J. 1997;157(9):1268-1271.
18. Athens News Agency: News in English (AM), 98-12-22. Athens hospital physicians’ workstoppages over payments.
Published December 1998. Accessed June 21, 2011.
19. Harrison M. A profession in conflict: Union militancy among Israeli physicians. Current Research
on Occupations and Professions. 1991;6:179-199.
20. Ackermann RT, Carroll AE. Support for national health insurance among U.S. physicians: a
national survey. Ann Intern Med. 2003;139(10):795-801.
JULY 2011
Translating Science into Sound Clinical Practice
Pregnancy Complications
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Fetal ultrasound
How to put safety first
Understanding the potential risks associated with fetal ultrasound and the key safety
issues are the foundation for optimal use of this important imaging modality.
he number of indications for ultrasound examination during pregnancy
is rising. In addition, experts have expanded the gestational age range for which
fetal ultrasound assessment is appropriate to
include the first trimester. Considering the
increased use of ultrasound, should clinicians heighten their concern regarding the
safety of this technique? Are there ways to
minimize potential risks to the fetus? What
do clinicians need to know about the safety
of this important imaging modality during
pregnancy? Te answers are not as straightforward as one might think.
This article reviews the potential impact of ultrasound on the fetus and ways
through which the sonographer can minimize risk and maximize safety. A key element of this is understanding how to use
the output display standard (ODS) during
all obstetric ultrasound examinations. Te
ODS, which is displayed on screen during
JULY 2011
an ultrasound examination, provides an
approximation of biologic risk generated
during the exam. It is currently the safety
mechanism in place for all ultrasound examinations, and the American College of
Obstetricians and Gynecologists (ACOG)
supports its use.1
Potential bioeffects of ultrasound
Ultrasound differs from other imaging modalities in that it is nonionizing and, thus,
considered safer for fetal evaluation.2 Nevertheless, obstetric ultrasound may produce
biologic changes through 1 of 2 mechanisms: thermal or nonthermal.
Thermal bioeffects refer to biologic
changes associated with a rise in temperature in the targeted tissue.3 Although some
ultrasound waves ref lect off the exposed
tissue and are used for the generation of images, others are absorbed by the tissue and
the energy is converted into heat. 3 T is is
important given the potential teratogenicity
of fetal exposure to significant temperature
Nonthermal bioeffects, frequently referred to as mechanical bioeTects, are biologic changes resulting from ultrasound
insonation without a pathophysiologic rise
in temperature. Although this concept is
somewhat abstract, it nonetheless appears
to be relevant in fetal ultrasound safety. 5
Examples of mechanical bioeTects observed
with diagnostic ultrasound include cavitation, acoustic streaming, radiation forces, and free-radical generation. The term
cavitation, which is frequently encountered
when investigating mechanical bioeffects,
refers to the interaction between an ultrasound wave and a gas bubble.5 Ultrasound
waves can cause gas bubbles to move, expand, or collapse. At the cellular level, even
slight movement of gas bubbles can potentially disrupt cellular connections.
Output display standard
ffe ODS was created by the American Institute of Ultrasound in Medicine and the
National Electrical Manufacturers Association to approximate the risks for thermal
and mechanical bioeTects encountered during an ultrasound examination. As noted earlier, use of the ODS is supported by
ACOG1 as well as by the US Food and Drug
Administration (FDA).6 ffe ODS includes
the thermal index (TI) and the mechanical
index (MI), which are calculated by the ultrasound machine and displayed in a corner
on screen if the machine is capable of generating a TI or MI greater than 1. ffe higher
the TI or MI value, the greater the probability of a thermal or mechanical bioeTect.6 As
a general rule, an index value less than 1 is
considered safe (Table 1).6 Displaying the index number on the screen allows the clinician or sonographer to monitor the number
while scanning. If the index value is greater
JULY 2011
Use of the ODS for maintenance
of safe index values during ultrasound
Goal for safety
Need to consider
Abbreviations: MI, mechanical index; ODS, output display standard; TI, thermal index.
Information from Barnett SB et al.6
Although ultrasound is
nonionizing radiation,
it has the potential to
produce thermal and
mechanical bioeffects
that warrant caution.
The Output Display
Standard (ODS)
approximates the
risks of thermal and
mechanical bioeffects
of ultrasound exposure.
The ODS ideally should
always be less than 1.
than 1, the sonographer can make necessary adjustments. Minimizing the exposure
time, changing the ultrasound mode, or
adjusting such settings as the power output
all can afiect the TI or MI values (Table 2).6,7
Te FDA is responsible for designating
an upper limit for the allowable output of
ultrasound machines. In 1976, this value
was set fairly low, at 94 mW/cm 2 , for fetal
exposure.6 As technology improved, clearer images and Doppler capability required
more powerful output settings. To permit
clinical use of these newer ultrasound machines, the FDA increased the allowable
output for obstetric ultrasound machines in
1992 to 720 mW/cm2: nearly 8 times higher
than the previous limit.6 Currently, instead
of ultrasound safety being regulated strictly
by the FDA, the responsibility rests largely
with the sonographer, who is required to
ensure that the limits of the ODS are not exceeded during the ultrasound examination.6
Evidence for ultrasound exposure
causing biologic risk
Te available evidence on fetal development
and neonatal outcomes after ultrasound
exposure is strongly reassuring. Much of
the research that raises concerns about ulTABLE 2.
Appropriate adjustments
if the TI or MI exceeds 1
Shorten examination time
Change to lower output mode (such as changing Doppler
to standard B-mode)
Adjust ultrasound settings
• Power output
• Area of color flow
Abbreviations: MI, mechanical index; TI, thermal index.
Information from Barnett SB, et al6; Abramowicz JS.7
JULY 2011
trasound safety was conducted in animals.
A 2006 study addressed the possibility that
ultrasound exposure might affect the migration of cerebral neurons. 8 The authors
of the study exposed pregnant mice late
in gestation to ultrasound delivered at
6.7 MHz, a slightly higher frequency than
that typically used in humans. Total exposure over a 3-day period ranged from 5 minutes to 420 minutes. Longer exposure times
correlated with decreased migration of neurons, which was signiffcant for all exposure
times longer than 15 minutes. 8 Given the
exposure conditions used, the investigators
did not believe that temperature was the
likely mechanism. Instead they proposed
that mechanical efiects altered the cellular
Other studies in mice suggested decreased birth weight in ultrasound-exposed
subjects, although follow-up growth at
6 weeks of age was similar to that of unexposed controls.9 Investigators reported
postnatal lung hemorrhage in mice in 1990,
leading to investigations in prenatal subjects.10 Investigators also found hemorrhages in the brains of fetal mice exposed to
pulsed ultrasound.11
In contrast, data in humans generally
have not shown a link between prenatal
ultrasound exposure and adverse clinical outcomes. Between 1992 and 1994,
researchers published a series of papers
based on the results from 2 randomized
clinical trials in Norway.12-15 Tey assessed
clinical outcomes, including body weight
and height, school performance, dyslexia, vision, hearing, and speech development in more than 2,000 children who
had been either exposed or not exposed
to ultrasound at 19 weeks’ and 32 weeks’
gestation. The assessment, which took
place when the children were 7, 8, or
9 years of age, found no difierences in any of
the clinical outcomes between the exposed
and the unexposed children.
Similar results from a randomized clinical trial in Sweden published between 1997
and 1998 again demonstrated no difierences
in weight, height, vision, hearing, or neurological development between children ex-
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Changing expectations
The sonographer
is responsible for
ultrasound safety.
Results of studies
in fetal animals link
ultrasound exposure
with adverse
Data from human
studies have not
shown an association
between adverse
clinical outcomes and
prenatal ultrasound
posed to ultrasound at 15 weeks and unexposed children, all of whom were assessed at
8 or 9 years of age.16,17
Other studies have shown no association
between ultrasound exposure and childhood cancer.18-20 Moreover, investigators
have noted similarities in birth weights, Apgar scores, neonatal intensive care unit admissions, and other outcomes among ultrasound-exposed and -unexposed subjects.21-23
Interestingly, 1 clinical outcome for
which a possible association persists is
non-right-handedness. In a follow-up of
the previously mentioned Norwegian trials, 12-15 the odds of non-right-handedness in children exposed to ultrasound at
19 weeks’ and 32 weeks’ gestation were
higher than those of nonexposed children
(odds ratio [OR], 1.32; 95% confidence interval [CI], 1.02-1.71).24 In this study, nonright-handedness included children who
used both hands equally or their leT hand
Follow-up of the Swedish trial16,17 found
no difference in non-right-handedness between the ultrasound-screened and the
nonscreened groups overall, but reported
an increased OR of non-right-handedness
among boys (OR, 1.33; 95% CI, 1.02-1.74).25
A meta-analysis of these trials found no
overall difference between the ultrasoundexposed and -unexposed groups; however,
a subgroup analysis of males revealed an
increased risk for non-right-handedness
among the ultrasound-exposed children
(OR, 1.26; 95% CI, 1.03-1.54). 26 Although
this association does not appear to be particularly strong, other studies have yet to
disprove the finding.
Doppler and ultrasound safety
Frequent assessment of the ODS is particularly important during Doppler ultrasound
examinations. The output potential of ultrasound varies according to mode. Because
Doppler uses higher acoustic power focused
on a specific fetal volume, its output is higher than that of standard ultrasound modes.
A good example is the use of middle cerebral artery (MCA) Doppler ultrasound
for detection of fetal anemia. Bone has a
JULY 2011
higher absorption potential than other tissues. fus, MCA Doppler involves the use
of a higher output ultrasound setting, which
is focused on the tissue with the high ultrasound absorption potential. f is is not to
say that a medically indicated MCA Doppler
ultrasound examination should not be performed. On the contrary, the risk-to-benefit
ratio generally favors use of this noninvasive
approach with a challenging diagnosis. It is
simply important to bear in mind the potential impact of the imaging modality being used and to recognize the safety guidelines that are in place for its use.
A 2007 study supported the higher
acoustic output potential of Doppler ultrasound over 2-dimensional imaging. Researchers recorded TI during 63 ultrasound
examinations, using standard B-mode or
Doppler imaging. 27 The mean TI was 0.3
with B-mode sonography, 0.8 with Doppler
color f low imaging, and 1.5 with pulsedwave Doppler imaging. fe study demonstrated that a mean TI greater than 1 can
occur during a Doppler ultrasound examination, particularly with pulsed-wave Doppler.
In 2009, a study in chicks showed an effect of pulsed Doppler ultrasound on memory and learning. Investigators exposed
chicks either to standard B-mode ultrasound or to pulsed Doppler. fey noted no
differences in memory in the B-mode group
aTer as long as 10 minutes’ exposure; however, chicks demonstrated decreased shortand long-term memory aTer just 4 minutes
of exposure to pulsed Doppler ultrasound.28
Overall, studies in humans are reassuring with respect to clinical outcomes aTer
Doppler exposure. 29 However, researchers
reported concern regarding growth restriction and Doppler exposure in 1 clinical trial
in which women were randomized to receive either a single ultrasound imaging
study at 18 weeks’ gestation (the regular
group) or both ultrasound imaging and
continuous-wave Doppler f low studies at
18, 24, 28, 34, and 38 weeks’ gestation (the
intensive group).30 fe researchers reported
a significant association with growth restriction in the intensively scanned group,
with a higher proportion of birth weights
under the tenth percentile (relative risk
[RR], 1.35; 95% CI, 1.09-1.67; P=.006) and
under the third percentile (RR, 1.65; 95%
CI, 1.09-2.49; P=.020). Follow-up of the ofispring at ages 1, 2, 3, 5, and 8 years, however, revealed similar growth between the
2 groups.31 Te investigators also evaluated
developmental outcomes, including language, social, and motor assessments, and
found no differences between the groups.
Data on the safety of fetal ultrasound exposure generally are reassuring. However,
most studies on the subject were conducted
prior to 1990, during a period in which the
allowable output potential for ultrasound
equipment was relatively reduced. Furthermore, at that time, obstetric ultrasound was
not performed as frequently in either highrisk or low-risk pregnancies as it is today.
Currently, in spite of the lack of deffnitive
evidence regarding the beneffts of obstetric
ultrasound screening in low-risk populations, a single targeted “anomaly” scan at
18 weeks’ to 20 weeks’ gestation is part of
routine practice. 32 Given the higher levels
of energy generated during contemporary
ultrasound examinations, new randomized
studies to assess the risks are warranted,
but would now be more difcult to perform
because the routine use of ultrasound in
pregnancy has become the de facto standard of care in the US. Studies conducted
to evaluate the efiect of Doppler ultrasound
also are needed.
Unfortunately, the level of knowledge
regarding ultrasound safety issues appears
to be less than desirable. In a 2005 survey
of attendees of European postgraduate obstetric ultrasound courses, only 22% and
11% of the participants could explain the TI
and MI, respectively, and only 28% could
locate this information on the ultrasound
screen.33 A similar survey of American ultrasound operators conducted in 2007 revealed comparable results: 17.7% and 3.8%
of the participants could describe the TI or
MI, respectively, and 20.8% could locate this
information on the display.34
Key points for ultrasound safety
• The operator is responsible for ultrasound safety.
• Look at the ODS while doing ultrasound.
• The ODS should be less than 1.
• Use extra care with new machines; evidence regarding their
use is limited.
• Be aware of higher output with Doppler ultrasound, particularly
during the first trimester.
Abbreviation: ODS, output display standard.
Overall, ultrasound appears to be safe.
However, clinicians should realize the
limitations in knowledge about the absolute safety of the technology and should
strive to ensure that users of the technology routinely employ safety mechanisms,
such as the ODS. Ultrasound safety is the
responsibility of the sonographer (Table 3).
Sonographers should review TI and MI
whenever an ultrasound examination is performed. If either index value is greater than
1, the duration or the settings of the examination should be adjusted, particularly if it
involves Doppler ultrasound.
Safety during imaging can be achieved by
adhering to a radiologic principle known as
ALARA, which stands for As Low As Reasonably Achievable. T is implies using the
minimum duration and the lowest possible
ultrasound exposure setting to obtain the diagnostic information needed to complete the
examination.6,35 As ultrasound technology
improves, new applications and more powerful machines are certain to be developed. We
hope these advancements also will yield machines with minimal risks, maximum safety,
and greater diagnostic potential.
The acoustic output
potential of Doppler
ultrasound surpasses
that of conventional
Although Doppler
ultrasound generally
is considered safe,
1 study suggested
intensive fetal Doppler
exposure may affect
birth weight.
Because data about
the safety of fetal
ultrasound are not
abundant, clinicians
and sonographers
should err on the
side of caution
when ordering and
performing prenatal
DR HOUSTON is a first-year maternal-fetal medicine
fellow and DR NEWMAN is vice chair, Academic Affairs
and Women’s Health Research, Department of MaternalFetal Medicine at the Medical University of South Carolina in
Charleston. Neither author reports any conflicts of interest,
real or apparent, with regard to the content of this article.
1. American College of Obstetricians and Gynecologists.
New ultrasound output display standard. ACOG Committee
Opinion Number 180, November 1996. Committee on
Obstetric Practice. Int J Gynaecol Obstet. 1997;57(2):
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2. American College of Obstetricians and Gynecologists
Committee on Obstetric Practice. Guidelines for diagnostic
imaging during pregnancy. ACOG Committee Opinion
Number 299, September 2004 (replaces Number 158,
September 1995). Obstet Gynecol. 2004;104(3):647-651.
3. Duck FA, Starritt HC. A study of the heating capabilities
of diagnostic ultrasound beams. Ultrasound Med Biol.
4. Edwards MJ. Review: hyperthermia and fever
during pregnancy. Birth Defects Res A Clin Mol Teratol.
20. Shu XO, Jin F, Linet MS, et al. Diagnostic X-ray and
ultrasound exposure and risk of childhood cancer. Br J
Cancer. 1994;70(3):531-536.
21. Lyons EA, Dyke C, Toms M, Cheang M. In utero exposure
to diagnostic ultrasound: a 6-year follow-up. Radiology.
22. Smith CB. Birth weights of fetuses exposed to diagnostic
ultrasound. J Ultrasound Med. 1984;3(9):395-396.
5. Stratmeyer ME, Greenleaf JF, Dalecki D, Salvesen KA.
Fetal ultrasound: mechanical effects. J Ultrasound Med.
23. Bakketeig LS, Eik-Nes SH, Jacobsen G, et al.
Randomised controlled trial of ultrasonographic screening in
pregnancy. Lancet. 1984;2(8396):207-211.
6. Barnett SB, Ter Haar GR, Ziskin MC, Rott HD, Duck FA,
Maeda K. International recommendations and guidelines for
the safe use of diagnostic ultrasound in medicine. Ultrasound
Med Biol. 2000;26(3):355-366.
24. Salvesen KA, Vatten LJ, Eik-Nes SH, Hugdahl K,
Bakketeig LS. Routine ultrasonography in utero and
subsequent handedness and neurological development.
BMJ. 1993;307(6897):159-164.
7. Abramowicz JS. Ultrasound in obstetrics and gynecology:
is this hot technology too hot? J Ultrasound Med.
25. Kieler H, Axelsson O, Haglund B, Nilsson S,
Salvesen KA. Routine ultrasound screening in pregnancy
and the children’s subsequent handedness. Early Hum Dev.
1998; 50(2):233-245.
8. Ang ES Jr, Gluncic V, Duque A, Schafer ME, Rakic P.
Prenatal exposure to ultrasound waves impacts
neuronal migration in mice. Proc Natl Acad Sci USA.
9. Hande MP, Devi PU. Effect of in utero exposure to
diagnostic ultrasound on the postnatal survival and growth of
mouse. Teratology. 1993;48(5):405-411.
10. Child SZ, Hartman CL, Schery LA, Carstensen EL. Lung
damage from exposure to pulsed ultrasound. Ultrasound Med
Biol. 1990;16(8):817-825.
11. Dalecki D, Child SZ, Raeman CH, Cox C. Hemorrhage
in murine fetuses exposed to pulsed ultrasound. Ultrasound
Med Biol. 1999;25(7):1139-1144.
12. Salvesen KA, Jacobsen G, Vatten LJ, Eik-Nes SH,
Bakketeig LS. Routine ultrasonography in utero and
subsequent growth during childhood. Ultrasound Obstet
Gynecol. 1993;3(1):6-10.
13. Salvesen KA, Bakketeig LS, Eik-Nes SH, Undheim JO,
Økland O. Routine ultrasonography in utero and school
performance at age 8-9 years. Lancet. 1992;339(8785):
14. Salvesen KA, Vatten LJ, Jacobsen G, et al. Routine
ultrasonography in utero and subsequent vision and
hearing at primary school age. Ultrasound Obstet Gynecol.
1992;2(4):243-244, 245-247.
15. Salvesen KA, Vatten LJ, Bakketeig LS, Eik-Nes SH.
Routine ultrasonography in utero and speech development.
Ultrasound Obstet Gynecol. 1994;4(2):101-103.
16. Kieler H, Haglund B, Waldenström U, Axelsson O.
Routine ultrasound screening in pregnancy and the children’s
subsequent growth, vision and hearing. Br J Obstet Gynaecol.
17. Kieler H, Ahlsten G, Haglund B, Salvesen K, Axelsson O.
Routine ultrasound screening in pregnancy and the children’s
subsequent neurologic development. Obstet Gynecol.
1998;91(5 pt 1):750-756.
18. Kinnier Wilson LM, Waterhouse JA. Obstetric ultrasound
and childhood malignancies. Lancet. 1984;2(8410):997-999.
19. Cartwright RA, McKinney PA, Hopton PA, et al.
Ultrasound examinations in pregnancy and childhood cancer.
Lancet. 1984;2(8410):999-1000.
JULY 2011
26. Salvesen KA, Eik-Nes SH. Ultrasound during pregnancy
and subsequent childhood non-right handedness: a metaanalysis. Ultrasound Obstet Gynecol. 1999;13(4):241-246.
27. Sheiner E, Shoham-Vardi I, Pombar X, Hussey MJ,
Strassner HT, Abramowicz JS. An increased thermal index
can be achieved when performing Doppler studies in
obstetric sonography. J Ultrasound Med. 2007;26(1):71-76.
28. Schneider-Kolsky ME, Ayobi Z, Lombardo P, Brown D,
Kedang B, Gibbs ME. Ultrasound exposure of the foetal chick
brain: effects on learning and memory. Int J Dev Neurosci.
29. Mason GC, Lilford RJ, Porter J, Nelson E, Tyrell S.
Randomised comparison of routine versus highly selective
use of Doppler ultrasound in low risk pregnancies. Br J
Obstet Gynaecol. 1993;100(2):130-133.
30. Newnham JP, Evans SF, Michael CA, Stanley FJ,
Landau LI. Effects of frequent ultrasound during pregnancy:
a randomised controlled trial. Lancet. 1993;342(8876):
31. Newnham JP, Doherty DA, Kendall GE, Zubrick SR,
Landau LL, Stanley FJ. Effects of repeated prenatal
ultrasound examinations on childhood outcome up to 8 years
of age: follow-up of a randomised controlled trial. Lancet.
32. LeFevre ML, Bain RP, Ewigman BG, Frigoletto FD,
Crane JP, McNellis D. A randomized trial of prenatal
ultrasonographic screening: impact on maternal
management and outcome. RADIUS (Routine Antenatal
Diagnostic Imaging with Ultrasound) Study Group. Am J
Obstet Gynecol. 1993;169(3):483-489.
33. Maršál K. The output display standard: has it missed its
target? Ultrasound Obstet Gynecol. 2005;25(3):211-214.
34. Sheiner E, Shoham-Vardi I, Abramowicz JS. What do
clinical users know regarding safety of ultrasound during
pregnancy? J Ultrasound Med. 2007;26(3):319-325.
35. American College of Obstetricians and Gynecologists.
ACOG Practice Bulletin Number 101, February 2009:
Ultrasonography in pregnancy. Obstet Gynecol. 2009;113(2
pt 1):451-461.
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An evolving specialty
confronts workforce changes
The specialty of obstetrics and gynecology is changing in terms of workforce needs and
expectations. We hope this commentary will serve as a basis for ongoing dialogue within
our profession as well as with patients and other stakeholders.
ike many other specialties in medicine,
the field of obstetrics and gynecology
faces numerous workforce challenges.
Te demand for services is rising, the supply
of physicians remains relatively constant, and
gender and generational changes are having a
significant impact on the culture of practice.
In addition, geographic maldistribution
Have you prepared your practice of physicians continues to plague ob/gyn
and yourself if a hospital comes as it does many other medical specialties.
wooing? Take the right steps:
Furthermore, both the impending changes in
healthcare delivery and the ever-present need
to contain costs can influence an evolving
Anticipated physician shortage
T he a c a d e m ic m e d ic a l c om mu n it y
recognizes the need for an increased
number of physicians in this country. In
2006, the Association of American Medical
Colleges (AAMC) called for a 30% increase
in graduates from medical schools in the
JULY 2011
United States. According to a recent AAMC
report, first-year medical school enrollment
will be 23% higher in 2014 than it was in
2002.1 Residency training positions, which
are the prerequisite for practice, have grown
slowly—about 1% per year—albeit mostly
in primary care fields, and have not kept
pace with either population growth or
allopathic and osteopathic medical school
Compounding this issue is the fact that
the number of active physicians approaching retirement age will nearly double in the
next decade. 3 An analysis of demographic data from the American Congress of
Obstetricians and Gynecologists (ACOG)
reveals that the percentage of ob/gyns
55 years of age and older rose from 25%
in 2002 to 35% in 2010 (Figure).4 Another
contributing factor is the significant increase in the percentage of female physicians, who will occupy a greater propor-
tion of part-time positions and will work
fewer patient-care hours than their male
Several recent reports predict a likely
shortage of physicians in at least 21 medical and surgical specialties. 6 Separate
studies were conducted by the federal
government 3 and the AAMC’s Center for
Workforce Studies.7
The AAMC study examined various
scenarios related to the change in supply
and demand for physicians in the future.7
Under t he “most plausible scena rio,”
the investigators projected a shortage of
159,300 physicians by the year 2025.7 It is
noteworthy that these projections assume
supply equals demand in the base year,
yet we know that 65 million Americans
reside in areas designated by the Health
Resources and Services Administration as
“health professional shortage areas.”8
The potential ramifications of a physician workforce shortage in ob/gyn could
be profound. Specific sectors of our specialty, including urogynecology and oncology, might consequently require improved access to care. 9 A vicious cycle
could ensue if physicians, compelled to
see more patients or work longer hours
to meet patient service needs, decide to
eliminate certain aspects of their practice. For example, the aging population
will require increased healthcare services,
which would consequently affect the field
of gynecology, depending on the practice
type. Older patients are likely to have an
increased need for the management of
urinary incontinence, pelvic organ prolapse, and gynecologic malignancies.
Professional liability also must be considered in the future workforce equation.
According to the 2009 ACOG Survey on
Professional Liability, between 2006 and
2008, 30.2% of physicians reported that
they had decreased the number of highrisk obstetric patients that they treated
and 8% stopped practicing obstetrics altogether because of the risk or fear of
professional liability claims or litigation.10
Evolving conditions
in ob/gyn practices and leadership
Our specialty is undergoing a dramatic
gender shift, with significant increases
in the number and proportion of female
ob/g yns. The percentage of female ob/
gyn residents increased from 58% in 1995
to 75% in 2005.11 According to a recent
AAMC analysis, however, no corresponding growth has occurred in the number of
JULY 2011
ACOG fellows age 55 or older
The proportion of obstetricians/gynecologists 55 years of age and older who are fellows in the American Congress
of Obstetricians and Gynecologists increased from 25% in 2002 to 35% in 2010. From: Rayburn WF.4 Reprinted
with permission.
By 2025, the number
of physicians in the
US is expected to
decrease by 159,300.
Demand for certain
ob/gyn subspecialties
is expected to
increase as the US
population ages.
Fear of professional
liability claims has
caused some ob/gyns
to stop performing
certain procedures or
leave practice.
women in ob/gyn leadership positions in
US medical schools.12 In 2008, compared
with women, 3.7 times more men held
division/section chief positions, 3.7 times
more men held associate chair/vice chair
positions, and 6.9 times more men held
departmental chair positions.12 Whether
this is a function of the relative unavailability of part-time or less traditional employment opportunities for faculty members requires further study.
Although the number of physicians
working part time has increased, several studies demonstrate no difference in
performance measures between part-time
and full-time practitioners.13,14 fi is is reassuring news, but from a long-term public
health perspective, an increase in the number of part-time practitioners may negatively affect access to care and therefore
requires tracking. Moreover, potential barriers to part-time practice include fixed
professional liability premiums, medical
student debt, incomparable beneTts packages, lower income, practice instability,
and questionable future professional opportunities.
If physicians do eliminate certain aspects of their practice for a time or stop
practicing altogether, some may decide to
return to clinical practice. fie exact extent
to which physician reentry will become an
JULY 2011
issue in the ob/gyn specialty is unknown.
A recent study of 5,000 physicians listed as
being “inactive” in the American Medical
Association (AMA) Physician Masterfile
revealed that 15% had reentered the workforce.15 Very few retraining programs exist;
those that do require signiTcant travel and
a substantial T nancial commitment.16
State licensing boards and hospital credentialing committees are beginning to
look at the requirements for reentering
physicians. In addition, ACOG and the
AMA should continue to work to facilitate creation of programs throughout the
country that include standardized mechanisms for evaluation and certification.
Another issue of significant importance to physicians is work-life balance.
Traditional gender roles may complicate
this issue for women. Woodrow and colleagues noted, “Female physicians spend
more than twice as much time as male
physicians on family and household work,
despite comparable professional hours.”17-19
This situation may have contributed to a
recent special issue of Time magazine being devoted to “fie State of the American
Woman.” The following line is displayed
on the cover: “A new poll shows that they
[women] are more powerful—but less happy,” and one of the articles in this issue is
titled, “Daily life is a story of diplomacy
under stress.”20 It is interesting to note that
employee assistance programs, mentoring,
and education on available resources play
important roles in helping physicians avoid
burnout and improve their sense of well
Data demonstrate that male and female
ob/gyns experience similar degrees of satisfaction with their medical practices. 21
However, a cultural bias may be evolving
against male ob/gyns in media portrayals. A recent study of 6 magazines geared
toward female readers revealed that female ob/gyns were interviewed as physician experts 47% to 80% of the time. In 5
magazines, pronouns referring to physicians were changed from gender-neutral
to female-specific. 22 Although one must
acknowledge that historically women were
not embraced as physicians by either the
medical profession or the public, it is important to confront discrimination against
men as the pendulum swings in the other
direction. fiose in charge should aim at
directing requests for media interviews
that are conducted through medical and
academic institutions to both male and female ob/gyns.
Workforce pipeline considerations:
medical education
One cannot discuss potential workforce
changes in this country without addressing
the future number of ob/gyns and their
training. Our profession must meet the
service needs of the population. When
determining the appropriate number of
physicians needed to provide care, advances
in the profession and demographic changes
must be considered. The very definition
of what the practice of ob/gyn entails has
changed or evolved significantly over the
past few decades.
Since the advent of managed care several decades ago, a debate has persisted
regarding whether ob/gyns should be considered primary care providers or specialists. The availability of uterine artery
embolization, progesterone-releasing intrauterine devices, and endometrial ablation techniques has been associated with
a signif icant decrease in the need for
hysterectomies. Surveillance data reveal
a 1.9% decrease per year in US hysterectomy rates from 1997 to 2005. 23 Some
residents have graduated from accredited
programs having performed as few as 12
vaginal hysterectomies. The impressive
growth of laparoscopic hysterectomies
also contributes to the use of fewer open
abdominal procedures. 24 Robotic surgery,
in which 1 surgeon often is the only person manipulating the instruments, is now
part of nearly all training programs but
may have a negative impact on the residency surgical experience.
Although all of these minimally invasive techniques can have potentially significant benefits for patients, we cannot
ignore the effect they are having on resi-
dent training. In some institutions, the
only patients undergoing total abdominal
hysterectomies are those with significant
operative risk factors, which limits the
number of learning opportunities for junior residents to become proficient and
to eventually handle more challenging
cases, including cesarean hysterectomies.
All of these challenges to education
offer opportunities to reevaluate our current graduate medical education (GME)
structure, which tends to overemphasize
inpatient care, traditional didactic teaching, and off-ser vice time. The current
system offers all residents the same experience regardless of their indiv idual practice or fellowship plans. Formal
training in such aspects as patient safety,
informatics, and practice management
might be invaluable to them. Given the
limitations of GME funding and the current work-hour restrictions, perhaps we
should reevaluate the length and format
of training in favor of a 2- or 3-year core
experience for all residents, with more
learner-driven focus the remainder of the
time. Tools such as patient simulation
and competencies are helpful but they
cannot provide the depth of experience
gained from surgical mentoring or reallife ambulatory care experiences.
One obvious solution to the looming
physician workforce shortage would be
to increase the number of residency positions in ob/gyn. Although this seems to
be a necessary step, several important
aspects must be considered. For example,
if the volume of surgical procedures being performed by graduating residents is
already insufficient, the addition of more
residents to the programs will serve to
dilute further the surgical experience. On
the other hand, the surgical volume of individual residents might increase if there
were fewer residents, but having fewer
residency slots in this country will only
exacerbate the predicted future workforce
shortage. Advocating for increased federal funding for GME is not likely to gain
much political traction in this era of deficits and spending reductions.
JULY 2011
The number of female
ob/gyns has grown
except in leadership
More physicians work
fewer hours or are
reentering practice
after leaving or
A cultural bias against
male ob/gyns may be
Ob/gyn procedures
being taught in
graduate medical
education (GME) are
Current GME offers
the same experience
to everyone, regardless
of their practice or
fellowship plans.
Both GME and the
ob/gyn specialty will
be forced to adapt by
workforce trends and
patient access.
Clearly, although many of these forces
are contradictory, our profession must
address all of them. If more physicians
are practicing part time and surgical volume is decreasing, skills will be compromised. If more physicians are retiring
early and the aging baby boomer generation requires additional care, access
to that care will be compromised. If residents’ surgical experiences are limited
by the number of work hours permitted
and educational content continues to expand as our understanding of molecular
biology and genetics evolves, graduates
will not be fully equipped to practice all
aspects of our specialty. Increasing the
number of ob/g y n residency program
slots to meet predicted physician shortages will further compromise surgical
experience for trainees.
Addressing evolving needs
Of the myriad challenges confronting our
specialty, workforce issues are the most
compelling. If they are not addressed, liability pressures will continue to affect patient access to care if physicians are reluctant to practice obstetrics or if they retire
prematurely from this aspect of practice.
Physician burnout compounded by issues
of increasing healthcare regulation and
paperwork contributes to this potential
crisis. 25 Thus, it is critically important
for our specialty to undergo continuous
workforce analyses. Ob/gyn was notably
absent from the 21 specialties highlighted
in the 2010 AAMC analysis titled, “Recent Studies and Reports on Physician
Shortages in the US.”6 A better understanding of potential patient access issues
could inf luence policy makers about the
need for meaningful tort reform.
Phy sic i a n-le d te a m s s t a f fe d w it h
nonphysician practitioners may help to
provide greater va lue in patient care.
Certified nurse midwives and nurse practitioners can be instrumental in meeting
burgeoning needs.
Evidence has shown that collaborative
ob/gyn practices improve outcomes. One
study that compared 179 advanced-practice
JULY 2011
nurse-obstetrician collaborative practice
patients with 181 university patients revealed “acceptable perinatal outcomes, as
judged by low birth weight and prematurity.”26 According to the fi ndings of another
study that evaluated 10 separate collaborative-care ob/gyn practices using patient
surveys: “ . . . patients in this survey were
accepting of the concept of collaborative
practice and felt that it oTered quicker appointments, more time with the provider,
more health information, and more specific diet information than did physician-only
Policy makers also should recognize
the importance of GME financing to selectively increase the number of ob/gyn
residency positions. A recent book by
Williams, Satiani, and Ellison concludes
that the surgical field with the most serious pending shortage of graduating
residents is ob/gyn, with approximately
14,000 too few slots. 28 The authors estimate that the current annual cost to
train each class is $312 million, and the
estimated cost to train the total number of residents deemed necessary from a
workforce perspective is $489 million. Although it would be money well spent, the
political leverage to dramatically increase
GME expenditures does not appear to exist at this time.
The needs and expectations of an evolving
society are transforming the field of ob/
gyn. Challenges and potential solutions
to current work force qua nda ries a re
outlined (Table). Forces at work include
t h e i nc re a s i n g nu m b e r of o b/g y n s
approaching retirement age, the growing
population of elderly women with greater
hea lt hca re needs, cont inued liabi lit y
pressures discouraging physicians from
practicing obstetrics, increasing gender
and generational issues that bring about
changes in practice patterns, and the
stagnant number of residency positions.
These factors contribute to the perception
of an impending shortage of ob/gyns that
could lead to decreased access to care.
Challenges and potential solutions
to impending workforce issues
Potential solutions
Number of retiring physicians
Part-time liability insurance rates
Part-time practice
Flexible job opportunities
Gender and generational
work hour changes
Laborists, collaborative
Aging population
Additional workforce studies
Physician geographic
Student loan forgiveness,
Liability pressures are greater
than limited practices
Meaningful liability reform
Inadequate GME positions
Enhanced GME financing/
residency slots
Abbreviation: GME, graduate medical education.
Compelling evidence exists for workforce stud ies in women’s hea lt hca re,
including the expanding roles of physician-led collaboratives with nonphysician practitioners. Aspects of ob/gyn
workforce needs that merit consideration
include physician burnout, par t-time
practice, physician reentry into clinical
practice, and gender bias.
Our specialty faces many challenges
in graduate and postgraduate education,
including the growth of minimally invasive procedures, increased awareness of
robotic surgery, and limited resident exposure to uncomplicated open abdominal
surgeries. Strategies to improve education and enhance practice patterns should
begin with an ongoing dialogue about
our specialty’s critical role in enhancing
women’s healthcare.
DR TRACY is an assistant professor at Harvard Medical
School and attending physician in the Vincent Obstetrics
and Gynecology Department at Massachusetts General
Hospital, Boston. DR RAYBURN is the Randolph
V Seligman Professor and Chair, Department of
Obstetrics and Gynecology, University of New Mexico,
Albuquerque. Dr Tracy has no conflicts of interest, real
or apparent, to disclose with regard to the content of
this article. Dr Rayburn reports that he is a member of
the faculty/advisory board of the American College of
Obstetricians and Gynecologists. The authors would like
to acknowledge Edward Salsberg, MPA, and Douglas W
Laube, MD, MEd, for their assistance.
1. Association of American Medical Colleges (AAMC)
Statement on the Physician Workforce—June 2006.
workforceposition.pdf. Accessed June 10, 2011.
2. Association of American Medical Colleges (AAMC)
Center for Workforce Studies. Results of the 2009
Medical School Enrollment Survey: Report to the
Council of Deans. April 2010. https://www.aamc.
Accessed June 10, 2011.
3. US Department of Health and Human Services. Health
Resources and Services Administration. Bureau of Health
Professions. The Physician Workforce: Projections and
Research Into Current Issues Affecting Supply and
Demand. December 2008.
bhpr/workforce/physicianworkforce.pdf. Accessed June
10, 2011.
4. Rayburn WF. The obstetrician-gynecologist workforce
in the United States: Facts, figures, and implications
2011. Washington, DC: American Congress of
Obstetricians and Gynecologists; 2011.
5. Cull WL, O’Connor KG, Olson LM. Part-time
work among pediatricians expands. Pediatrics.
6. Association of American Medical Colleges (AAMC)
Center for Workforce Studies. Recent Studies and
Reports on Physician Shortages in the US. May 2011.
recentworkforcestudiesnov09.pdf. Accessed June 10,
7. Dill MJ, Salsberg ES; Center for Workforce Studies.
The Complexities of Physician Supply and Demand:
Projections Through 2025. Washington, DC: Association
of American Medical Colleges; 2008.
8. US Department of Health and Human Services.
Health Resources and Services Administration. Health
Professions. Shortage Designation: Health Professional
Shortage Areas and Medically Underserved Areas/
Populations. Accessed
June 10, 2011.
9. Morrill M, Lukacz ES, Lawrence JM, Nager CW,
Contreras R, Luber KM. Seeking healthcare for pelvic
floor disorders: a population-based study. Am J Obstet
Gynecol. 2007:197(1):86.e1-86.e6.
10. Klagholz J, Strunk AL. Overview of the 2009 ACOG
Survey on Professional Liability.
al.pdf. Accessed June 10, 2011.
11. Brotherton SE, Rockey PH, Etzel SI. US graduate
medical education, 2004-2005: trends in primary care
specialties. JAMA. 2005;294(9):1075-1082.
12. Association of American Medical Colleges (AAMC).
Women in U.S. Academic Medicine: Statistics and
Benchmarking Report. 2008–2009. https://www.aamc.
pdf. Accessed June 10, 2011.
13. Fairchild DG, McLoughlin KS, Gharib S, et al.
Productivity, quality, and patient satisfaction: comparison
of part-time and full-time primary care physicians. J Gen
Intern Med. 2001;16(10):663-667.
14. Murray A, Safran DG, Rogers WH, Inui T, Chang
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H, Montgomery JE. Part-time physicians: physician
workload and patient-based assessments of primary care
performance. Arch Fam Med. 2000;9(4):327-332.
15. American Medical Association and American
Academy of Pediatrics. Physician reentry into the
workforce conference. Issue Brief 2: Data on reentry
physicians. _
issuebrief2_final.pdf. Accessed June 17, 2011.
16. American Medical Association Council on Medical
Education 2008 report on physician reentry. http://www.
pdf. Accessed June 10, 2011.
17. Woodrow SI, Gilmer-Hill H, Rutka JT. The
neurosurgical workforce in North America: a critical
review of gender issues. Neurosurgery. 2006;59(4):749755; discussion 755-758.
18. Cujec B, Oancia T, Bohm C, Johnson D. Career and
parenting satisfaction among medical students, residents
and physician teachers at a Canadian medical school.
CMAJ. 2000;162(5):637-640.
19. Kao LS, Wilson EB, Anderson KD. Gender
differences among spouses of surgeons. Am J Surg.
20. Time Magazine Special Report: The State of the
American Woman. Time. October 26, 2009. http://www.,16641,20091026,00.html?artI
d=20091026?contType=gallery?chn=covers. Accessed
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21. Emmons SL, Nichols M, Schulkin J, James KE,
Cain JM. The influence of physician gender on practice
satisfaction among obstetrician gynecologists. Am J
Obstet Gynecol. 2006;194(6):1728-1739.
22. Kincheloe LR. Gender bias against male obstetriciangynecologists in women’s magazines. Obstet Gynecol.
2004;104(5 pt 1):1089-1093.
23. Merrill RM. Hysterectomy surveillance in the United
States, 1997 through 2005. Med Sci Monit. 2008;
24. Jacoby VL, Autry A, Jacobson G, Domush R,
Nakagawa S, Jacoby A. Nationwide use of laparoscopic
hysterectomy compared with abdominal and vaginal
approaches. Obstet Gynecol. 2009;114(5):1041-1048.
25. Merrit J, Hawkins J, Miller P. Will the Last Physician in
America Please Turn Off the Lights? A Look at America’s
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26. Mvula MM, Miller JM Jr. A comparative evaluation
of collaborative prenatal care. Obstet Gynecol.
27. Hankins GDV, Shaw SB, Cruess DF, Lawrence HC III,
Harris CD. Patient satisfaction with collaborative practice.
Obstet Gynecol. 1996:88(6):1011-1015.
28. Williams TE Jr, Satiani B, Ellison EC. The Coming
Shortage of Surgeons: Why They Are Disappearing and
What That Means for Our Health. Santa Barbara, CA:
Praeger/ABC-CLIO; 2009.
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San Francisco, Modesto offers easy access to vacation spots such
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as affordable housing, good schools, and great weather. We
offer competitive compensation, an excellent benefits package,
relocation allowance, and early partnership with no “buy in”.
If you are an experienced Maternal Fetal Medicine physician
interested in an excellent clinical and teaching opportunity in
beautiful New England, please contact Christine Bourbeau,
Physician Recruitment, at 855.894.5590, or email a letter of
interest and CV to [email protected]
Robotic assisted surgery
100% Gynecologic Oncology practice
20 referring Gould OB/GYN Physicians in 4 nearby locations
Full call coverage, 4½ day work week
Epic EMR
PACS radiology services
Contact Dr. C.V. Allen
Phone: (866) 454-6853 Fax: (209) 550-4892
[email protected]
To see the latest
ads, visit us at
JULY 2011
EEO/AA – M/F/D/V, pre-employment drug testing
Five-physician group with 3 nurse midwives seek a bc/be ob gyn
physician to join our thriving private practice in historic Eastern
Connecticut. We are affiliated with a progressive community hospital
that see’s about 500 deliveries per year; with on-site interventional
radiology, progressive obstetric care and full scale gyn and advanced
minimally invasive surgeries. We perform hysteroscopy, ablation and
BTL in our newly-renovated office.
Located in a two university town that is a short drive from NYC,
Boston and Providence, our community has affordable real estate,
exceptional schools and many recreational & cultural activities. Enjoy
reasonable call, fast partnership tract, and superb quality of life.
Colleen Tighe
[email protected]
Maternal Fetal Medicine
45 Minutes Frin ue Beaco!
Level 3 hospital ~ No emergency room call
Income potential unlimited
Send CV to e-mail: [email protected]
or fax: 407-209-3575
For more information, please call 407-418-9103
• Live and work in a great location
• Family-oriented, safe city with all
• Flexible schedule including part-time
• New 32-bed Level III NICU, OB unit,
Boise, Idaho
Seeking BC/BE OB/GYN physician and
BC/BE URO/GYN physician to join
5 physician group
Flexible Practice & Quality Lifestyle
maternal transport team and collegial
• MFM back-up/consultation
• Competitive compensation and benefits
with exceptional performance-based
▪ 24/7 laborist model
Contact: Sylvia Chariton at 800.309.5388
Email: [email protected] or
FAX: 208.367.7964
Family Health Centers of Southwest Florida,
Inc. (FHC) is a private, not for profit, multispecialty, Federally Qualified Healthcare Center and
has been Joint Commission accredited for 15 years.
Headquartered in beautiful Ft. Myers, Florida , our
community health center was established in the mid
1960’s. Please visit our website at
Fort Myers
FHC is offering a great opportunity for an experienced BC
OB/GYN; bilingual English-Spanish preferred. Our Women’s
Health Team has privileges at the state-of-the-art facilities of
Lee Memorial Health System Hospitals. A 3 On Call rotation
consisting of ten 12 hour shifts per month, including weekends,
behind 6 CNMs. Competitive Salary and Comprehensive Benefits
Package including Malpractice Insurance. J-1 Eligible.
Respond to Human Resources, P.O. Box 1357, Ft. Myers, FL 33902
or Fax (239) 278-3203; Email [email protected]
EOE/Drug Free
For RECRUITMENT Advertising,
[email protected]
SE Kansas College Community
Join well established private practice in dynamic family oriented
college community 45 minutes to Wichita and 90 minutes to
Tulsa associated with a modern and financially stable hospital
with up to date L/D Wing doing 300 annual deliveries. 1-3 call.
Excellent salary, bonus, benefits and future partnership. OBGYN
Search, 800-831-5475, Fax: 314-984-8246, [email protected],
Excellent position in patient-centered
OBGYN group practice. State-of-the-art
medical center; level II nursery; midwives;
Women’s Center; Excellent compensation
and benefits, 100% student loan
reimbursement! $25,000 Sign on bonus,
$10,000 moving expenses. Maine’s
second largest city. Home of Bates College.
40mins from Portland, Jetport, and coast.
Excellent public schools. Vibrant, diverse
patient population.
Contact: Susan Edson
[email protected] 207-866-5680
JULY 2011
St. Louis Area
Hospital employed obgyn position in family oriented community
45 minutes to St. Louis suburbs associated with a financially
stable hospital with modern birthing unit doing 200 annual
deliveries. 1-2 call. Excellent salary, bonus and benefits. OBGYN
Search, 800-831-5475, Fax: 314-984-8246, [email protected],
A well established growing practice is seeking a full-time OB/
GYN located in Bergen/Hudson county, NJ only minutes from
NYC. It is affiliated with a medical center which was recently
ranked 4th in the nation by Modern Healthcare Magazine for
“Best Places to Work”. The Medical Center handles about 1500
deliveries per year, offers onsite Interventional Radiology, a NeoNatology unit and advanced surgical services including robotic
procedures. Candidates must be board-certified in Obstetrics and
Requires participation in group call schedule. Salary is
commensurate with experience. Benefits include malpractice,
generous CME stipend, vacation, health/dental benefits, 401K
and profits sharing after 1 year.
Send inquiries to:
Ray Dreyfuss
718 Teaneck Road, Teaneck, NJ 07666
Fax: 201-833-3043
Farmington, New Mexico
Outstanding opportunity for BC/BE Ob-Gyn Physician to join
an independent group of four. New facility, on-site Sonography
and Pelvic Floor Therapy, Level I Nursery. Competitive salary,
excellent benefits, and relocation. Enjoy skiing, fishing, hiking,
golf, and many other outdoor adventures.
Contact Terri Smith
[email protected], phone (888)282-6591 or
Maternal-Fetal Medicine
New York, Mid-Hudson Valley
Openings for BC/BE Fellowship-trained
Maternal-Fetal Medicine Specialist.
Support over 20 general Ob/Gyn physicians within
multi-specialty group medical practice. 65 miles from
Manhattan. Opportunity for personal and professional
growth in the fastest growing practice in New York
State, located in one of the fastest growing regions in
New York State!
• State-of-the-art facility. • 10-bed Level II NICU located in all-new hospital birthing center.
• Electronic medical records. In-house Digital imaging, including MR, CT and Ultrasound.
• Excellent compensation/partnership track; outstanding opportunity in a unique and highly successful practice. Please Write, Fax or Email to:
Hal Teitelbaum, MD, MBA, Managing Partner
155 Crystal Run Road, Middletown, NY 10941
Fax: 845. 703. 6201
Email: [email protected]
Physician Wanted - NYC
Age-Management Clinic Established 1997
Board Certified / Eligible
Internist, Gynecologist or Endocrinologist
P/T (16-24 hrs/wk) No On-Call Contact Alicia at 212.888.7074
[email protected]
JULY 2011
SW New York
Hospital employed multispeciality group seeking Obgyn in
dynamic family oriented community 90 minutes to New York
City with offices in PA/NY associated with a financially stable
189 bed hospital with up to date birthing unit doing 300 annual
deliveries. 1-3 call. Excellent salary, bonus and benefits. OBGYN
Search, 800-831-5475, Fax: 314-984-8246, [email protected],
Recruitment Advertising Can Work For You!
Hospital employed position joining two obgyn’s in family oriented
Finger Lakes region 45 minutes to Rochester associated with
a modern and financially stable 72 bed hospital with beautiful
L/D Unit doing 300 annual deliveries. 1-3 call. Excellent salary,
bonus and benefit package. OBGYN Search, 800-831-5475, Fax:
314-984-8246, [email protected],
Intermountain is frequently referenced nationally as one of
the leaders in delivering high quality/low cost health care.
Intermountain Healthcare needs one experienced BC OB/GYN
in Heber, Utah. Send CV to Intermountain Healthcare, Physician
Recruiting, 36 S. State St, 21 Fl, Salt Lake City, UT 84111.
Rochester Area
NE Ohio
Hospital employed obgyn position in dynamic family oriented
community one hour to Cleveland and Pittsburgh associated with
a modern and financially stable 120 bed hospital with beautiful L/D
Wing doing 500-600 annual deliveries. 1-3 call going to 1-4. Excellent
salary, bonus and benefits. OBGYN Search, 800-831-5475, Fax:
314-984-8246, [email protected],
Intermountain is frequently referenced nationally as one of
the leaders in delivering high quality/low cost health care.
Intermountain Healthcare needs one BC/BE gynecologist in
Provo, Utah. Send CV to Intermountain Healthcare, Physician
Recruiting, 36 S. State St, 21 Fl, Salt Lake City, UT 84111.
Pittsburgh Area
Two well established lucrative private practices in family oriented
communities 45 minutes to downtown Pittsburgh seeking
physician for partnership and future takeover of the practice
in 259/209 Bed hospitals doing 500-1000 deliveries. 1-2/1-4 call
schedules. $250K salary,production bonus and benefits. OBGYN
Search, 800-831-5475, Fax: 314-984-8246, [email protected],
Join one of the largest recruitment
networks on the Internet with
over 250 partner sites.
Find The Best
Healthcare Candidates.
Call Today
For Web Package Details!
Jacqueline Moran
Phone: 800.225.4569, ext. 2762
E-mail: [email protected]
Ob/Gyn Generalist POsitiOn
Georgetown University Hospital / MedStar Health in the
Georgetown section of Washington, DC is seeking a Board
Certified / Board Eligible Ob/Gyn physician for the Generalist
Division. The position encompasses direct, full range of
Ob/Gyn patient care and an academic title at Georgetown
University Medical Center commensurate with experience
and training. Medical student and resident teaching is expected.
The hospital-based position involves a private practice setting
on site at GUH, a full-service hospital with a Level III NICU
and on-site MFM providers.
The Division of General Gynecology and Obstetrics is seeking
a personable and motivated provider with excellent clinical and
surgical skills; experience with laparoscopic and vaginal surgery
is desired. Call is one in 8-9 nights and only at GUH. Salary is
competitive with incentive potential based on productivity after
the first year. Malpractice costs are covered through the department and benefits are provided through MedStar Health.
For more information, please contact
Helain J. Landy, MD, Professor and Chair,
Department of Ob/Gyn, c/o Robin Reath
[email protected] or 202-444-8757
OB Opportunity in DC Join a highly respected and established private
practice in Virginia seeking an experienced obstetrics and gynecology
physician who wants to make a difference. The ideal candidate will
need to be a team player that can build a strong leadership role with
major healthcare facilities nearby. Exceptional salary with all benefits
and paid malpractice. Plus enjoy the DC/Fairfax area with cultural
activities and strong economy. Contact Natasha Bell at 800-586-5051
ex. 6682 or email [email protected] Ref#21570.
Visit Us Online:
JULY 2011
Citracal Qd
One A Day Women’s Prenatal
Her Option
Cervista HPV
Prevena Incision Management System
Inside front cover-2
HPV Test
Cover tip
Leadership in Patient Safety
5, 6
Inside back cover,
back cover
32, 33
• Myofascial pain syndrome: An overlooked source
of chronic pain
• Addressing the challenges of ectopic pregnancy
• MFM Consult: Evaluating and managing isolated
echogenic bowel
JULY 2011
The frequency and severity of local skin reactions were similar in both genders, with the following
exceptions: a) flaking/scaling occurred in 40% of men and in 26% of women and b) scabbing/crusting
occurred in 34% of men and in 18% of women.
In the clinical trials, 32% (126/400) of subjects who used ZYCLARA Cream and 2% (4/202) of subjects
who used vehicle cream discontinued treatment temporarily (required rest periods) due to adverse local
skin reactions, and 1% (3/400) of subjects who used ZYCLARA Cream discontinued treatment
permanently due to local skin/application site reactions.
Other adverse reactions reported in subjects treated with ZYCLARA Cream include: rash, back pain,
application site rash, application site cellulitis, application site excoriation, application site bleeding,
scrotal pain, scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, and
influenza-like symptoms.
External Genital Warts
Postmarketing Experience
ZYCLARA Cream is indicated for the treatment of external genital and perianal warts (EGW)/condyloma
acuminata in patients 12 years or older.
Limitations of Use
Treatment with ZYCLARA has not been studied for prevention or transmission of HPV.
Unevaluated Populations
The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:
D*,=272,4.;*=8<2<@1.7=;.*[email protected]=168;.=1*787.,B,5.=;.*=6.7=,8>;<.27=1.<*6.*;.*
D<>9.;ficial basal cell carcinoma.
The following adverse reactions have been identified during post-approval use of imiquimod. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug exposure.
Application Site Disorders: tingling at the application site.
Body as a Whole: angioedema.
Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias
(tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial
infarction, syncope.
Endocrine: thyroiditis.
Gastro-Intestinal System Disorders: abdominal pain.
Hematological: decreases in red cell, white cell and platelet counts (including idiopathic
thrombocytopenic purpura), lymphoma.
Hepatic: abnormal liver function.
Local Skin Reactions
Infections and Infestations: herpes simplex.
7=.7<.58,*5<427;.*,=287<27,5>-270<[email protected];.;8<287,*78,,>;*/=.;*/[email protected]*9952,*=287<8/
ZYCLARA Cream and may require an interruption of dosing. ZYCLARA Cream has the potential to
exacerbate inflammatory,87-2=287<8/=1.<42727,5>-270,1;872,0;*/=?.;<><18<=-2<.*<.
Musculo-Skeletal System Disorders: arthralgia.
surgical treatment.
Respiratory: dyspnea.
Systemic Reactions
of the patient should be considered.
Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions),
depression, insomnia, multiple sclerosis aggravation, paresis, suicide.
Urinary System Disorders: proteinuria, urinary retention, dysuria.
Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic
scar, hypopigmentation.
Vascular: Henoch-Schonlein purpura syndrome.
Ly691*-.789*=1B8,,>;;.-278/<>+3.,=<@2=1*,=272,4.;*=8<2<=;.*[email protected]=1)(#;.*6%12<
;.*,=287;.<85?.-27*55<>+3.,=<[email protected]<*/=.;,8695.=2878/=;.*=6.7=.
Ultraviolet Light Exposure Risks
There are no adequate and well-controlled studies in pregnant women. ZYCLARA Cream should be used
during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of ZYCLARA Cream.
"*=2.7=<<18>[email protected]*;7.-=8><.9;8=.,=2?.,58=1270.0*1*[email protected]><270)(#;.*6"*=2.7=<@2=h
sunburn should be advised not to use ZYCLARA Cream until fully recovered. Patients who may have
sunlight should exercise caution when using ZYCLARA Cream.
7*7*726*5918=8,*;cinogenicity study262:>268-,;.*6<18;=.7.-=1.=26.=8<427=>68;/8;6*=287
The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms.
Increased Risk of Adverse Reactions with Concomitant Imiquimod Use
The safety of concomitant use of ZYCLARA Cream and any other imiquimod products has not been
established and should be avoided since they contain the same active ingredient (imiquimod) and may increase
Immune Cell Activation in Autoimmune Disease
Z(#;.*6<18>5-+.><[email protected]=1,*>=287279*=2.7=<@2=19;..A2<=270*>=8266>7.,87-2=287<+.,*><.
imiquimod activates immune cells.
Because clinical trials are conducted under widely varB270,87-2=287<*-?.;<.;.*,=287;*=.<8+<.;ved in
the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
Clinical Trials Experience: External Genital Warts
[email protected]>+5.+527-95*,.+8,87=;855.-<=>-2.<
8;?.12,5.-*25B/8;>[email protected]<
Selected adverse reactions are listed in Table 1.
Table 1: Selected Adverse Reactions Occurring in ≥2% of ZYCLARA Treated Subjects and at a Greater
Frequency than with Vehicle in the Combined Trials (EGW)
ZYCLARA Cream 3.75%
Vehicle Cream
Preferred Term
Application site pain
28 (7%)
1 (<1%)
Application site irritation
2 (1%)
Application site pruritus
11 (3%)
2 (1%)
Vaginitis bacterial*
2 (2%)
1 (<1%)
if they required any medical intervention, or they resulted in patient discontinuation from the study. The
incidence and severity of selected local skin reactions are shown in Table 2.
Table 2: Selected Local Skin Reactions in the Treatment Area Assessed by the Investigator (EGW)
All grades*, (%)
ZYCLARA Cream 3.75%
Vehicle Cream
Severe, (%)
Severe erythema
Severe edema
Severe erosion/ulceration
Severe exudate
*Mild, Moderate, or Severe
Pregnancy Pregnancy Category C:
The animal multiples of human exposure calculations were based on daily dose comparisons for the
reproductive toxicology studies described in this label. The animal multiples of human exposure were
based on weekly dose comparisons for the carcinogenicity studies described in this label. For the animal
multiple of human exposure ratios presented in this label, the Maximum Recommended Human Dose
(MRHD) was set at 2 packets (500 mg cream) per treatment of actinic keratosis with ZYCLARA Cream
(imiquimod 3.75%, 18.75 mg imiquimod) for BSA comparison. The maximum human AUC value
obtained in the treatment of external genital and perianal warts was higher than that obtained in the
treatment of actinic keratosis and was used in the calculation of animal multiples of MRHD that were
based on AUC comparison.
Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 1, 5 and
20 mg/kg/day imiquimod were administered during the period of organogenesis (gestational days
6 – 15) to pregnant female rats. In the presence of maternal toxicity, fetal effects noted at 20 mg/kg/day
(163X MRHD based on AUC comparisons) included increased resorptions, decreased fetal body weights,
delays in skeletal ossification, bent limb bones, and two fetuses in one litter (2 of 1567 fetuses)
demonstrated exencephaly, protruding tongues and low-set ears. No treatment related effects on
embryofetal toxicity or teratogenicity were noted at 5 mg/kg/day (28X MRHD based on AUC comparisons).
Intravenous doses of 0.5, 1 and 2 mg/kg/day imiquimod were administered during the period of
organogenesis (gestational days 6 – 18) to pregnant female rabbits. No treatment related effects on
embryofetal toxicity or teratogenicity were noted at 2 mg/kg/day (2.1X MRHD based on BSA comparisons),
the highest dose evaluated in this study, or 1 mg/kg/day (115X MRHD based on AUC comparisons).
A combined fertility and peri- and post-natal development study was conducted in rats. Oral doses of
1, 1.5, 3 and 6 mg/kg/day imiquimod were administered to male rats from 70 days prior to mating
through the mating period and to female rats from 14 days prior to mating through parturition and
lactation. No effects on growth, fertility, reproduction or post-natal development were noted at doses
up to 6 mg/kg/day (25X MRHD based on AUC comparisons), the highest dose evaluated in this study.
In the absence of maternal toxicity, bent limb bones were noted in the F1 fetuses at a dose of
6 mg/kg/day (25X MRHD based on AUC comparisons). This fetal effect was also noted in the oral
rat embryofetal development study conducted with imiquimod. No treatment related effects on
teratogenicity were noted at 3 mg/kg/day (12X MRHD based on AUC comparisons).
Nursing Mothers
It is not known whether imiquimod is excreted in human milk following use of ZYCLARA Cream.
Because many drugs are excreted in human milk, caution should be exercised when ZYCLARA Cream
is administered to nursing women.
Pediatric Use
Safety and efficacy in patients with external genital/perianal warts below the age of 12 years have not
been established.
Geriatric Use
Clinical studies of ZYCLARA Cream for EGW did not include sufficient numbers of subjects aged 65 and
over to determine whether they respond differently from younger subjects. Of the 400 subjects treated
with ZYCLARA Cream in the EGW clinical studies, 5 subjects (1%) were 65 years or older.
Topical overdosing of ZYCLARA Cream could result in an increased incidence of severe local skin
reactions and may increase the risk for systemic reactions.
Hypotension was reported in a clinical trial following multiple oral imiquimod doses of >200 mg
(equivalent to ingestion of the imiquimod content of more than 21 packets of ZYCLARA). The
hypotension resolved following oral or intravenous fluid administration.
Rx Only
Manufactured by
3M Health Care Limited
Loughborough LE11 1EP England
Distributed by
Graceway Pharmaceuticals, LLC
Bristol, TN 37620
Issued: March 2011
What patients want in the treatment
of external genital warts (EGW)...
Effectively clears genital warts
and keeps patients clear
Short treatment, daily dosing
s Applied once daily for up to 8 weeks
Significant clearance in females
s 37% complete clearance, 48% partial clearance
_75% reduction in
– Partial clearance defined as >
EGW count from baseline
Patients who clear with Zyclara
can expect to remain clear
s Only 15% of patients had a recurrence at
12 weeks posttreatment1
Tough on warts, easy on patients
s Low incidence of treatment-related adverse events
at the application site: itching (3%), irritation (6%),
or pain (7%)1
s Local skin reactions, most of which were mild to
moderate, included severe erythema (9%) and
severe erosion/ulceration (11%)1
Zyclara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older.
In clinical studies, the most frequently reported adverse reactions were local skin and application site reactions. These reactions included
erythema, edema, erosion or ulceration, and exudate at the genital wart site. Most local skin reactions were rated as mild to moderate.
Intense local inflammatory reactions and/or flu-like systemic signs and symptoms can occur. Dosing interruptions may be required.
Avoid concomitant use of Zyclara Cream and any other imiquimod cream because of increased risk for adverse reactions.
Zyclara Cream is not recommended for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral
disease as it has not been studied.
The effect of Zyclara Cream on the transmission of genital warts is unknown. Zyclara Cream may weaken condoms and diaphragms.
Sexual contact should be avoided while the cream is on the skin.
Please see Brief Summary of Prescribing Information on adjacent page.
Reference: 1. Data on file. Graceway Pharmaceuticals, LLC.
©2011 Graceway Pharmaceuticals, LLC, Bristol, TN