The manufacturer of a device for permanent birth control that reportedly causes serious adverse events has decided to cease selling it at the end of the year. PLUS: Does smoking cessation really = weight gain? Also: Is prenatal depression more common today?
The manufacturer of a device for permanent birth control that reportedly causes serious adverse events has decided to cease selling it at the end of the year. The action is voluntary and follows restrictions on sales and distribution of Essure that were issued by the US Food and Drug Administration (FDA) in April.
The FDA estimates that Essure has been used by more than 750,000 women worldwide since it was first approved by global regulatory authorities. It involves insertion of coils into the Fallopian tubes to block passage of an egg from the ovary.
Implantation of the device has been associated with serious risks including persistent pain, uterine and Fallopian tube perforation, and coil migration into the pelvis or abdomen. Recent reports also have focused on issues related to surgery for removal of Essure. To address the reports, FDA ordered its manufacturer, Bayer, to conduct a post-market study and to add a boxed warning and a Patient Decision Checklist to the labeling.
In a press release, Bayer said that their decision “is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business if no longer sustainable.” A statement from FDA Commissioner Scott Gottlieb, MD, indicates that since the change to the labeling, sales of the device in the United States have fallen by approximately 70%.
Bayer will continue to enroll new participants in the post-marketing study, each of whom will be followed for 3 years. The company also will continue to submit reports to the FDA on the study’s progress and results.
The FDA said that women who use Essure can continue to do so and should consult with their doctors if they have symptoms related to the device. In its response to the impending removal of the device from the market, the American College of Obstetricians and Gynecologists encouraged ob/gyns to consult its Sterilization: Resource Overview for publications and resources on permanent contraception.
Does smoking cessation really = weight gain?
Many postmenopausal women who stop smoking express concern about weight gain. A first-of-its kind study has looked at the link between physical activity and weight in this population and the results point to the role that even minimal exercise plays in weight gain or loss.
Data for the research were from women aged 50 to 70 enrolled in the Women’s Health Initiative who self-reported as current smokers at baseline. Current smokers were defined as reporting yes to the question “During your life have you smoked at least 100 cigarettes?” and yes to a subsequent question, “Do you smoke now?” After exclusions for various reasons including cancer history, diabetes or cardiovascular disease at baseline, or missing information the resulting sample totalled 4,717 women.
Smoking frequency and status were collected at baseline and the year 3 follow-up visit. Women were defined as quitters if they reported not smoking at the latter visit. Physical activity (PA) was self-reported and also assessed at baseline and the year 3 follow-up visit. Type of PA (mild, moderate, and strenuous) was recorded as well as frequency (never to ≥ 5 days/week) and duration (< 20 min, 20-39 min, 40-59 min, and ≥ 1 hour). Metabolic equivalent task (MET) values were calculated by assigning strenuous, moderate, and mild exercise as 7, 4, and 3, respectively.
Compared with continuing smokers, quitters were more likely to have higher education, high BMI, greater waist circumference, and to be more physically active and smoke fewer cigarettes per day at baseline. New quitters also tended to have a better diet quality and increased PA than continuing smokers. Overall, quitters gained an average of 3.5 kg between the baseline and year 3 follow-up visit.
Increasing PA was associated with slightly but significantly less weight gain. Quitters with a decrease in PA had the highest weight gain (3.88 kg; 95% CI, 3.22-4.54). Quitters who increased their PA by ≥ 15 MET-hours/week had the lowest weight gain (2.55 kg; 95% CI, 3.22 -4.54). Women who had a high level of PA at baseline but decreased their PA by year 3 had the highest weight gain (4.94 kg; 95% CI, 2.15-3.12). Women who had a similarly high level of PA at baseline and by year 3 had the lowest weight gain (2.63 kg; 95% CI, 2.15-3.12).
The authors noted a few strengths and limitations of the study. Among the strengths were the large sample size, longitudinal design, measured weight and consideration of changes in dietary behaviors, and PA. The fact that both smoking status and PA were self-reported was a limitation.
The researchers also did not collect information on the exact point at which quitters stopped smoking, so some women could have stopped a few days before the year 3 visit and others may have done so several years before the questionnaire. However, they believe their findings can help clinicians who are counseling patients to quit smoking, especially women who are worried about gaining weight if they do quit.
Is prenatal depression more common today?
A multigenerational studyof prenatal depression by researchers from UK points to a need for increased screening and resources to support young mothers. The findings, published in JAMA Psychiatry, are based on screening for depression in two generations of women who lived in the same geographic area.
For the prospective cohort (Avon Longitudinal Study of Parents and Children [ALSPAC]), the authors recruited pregnant women (ALSPAC-G0) living in southwest England between 1990 and 1992. They, their partners, and their index children have been followed since then in ALSPAC G1. The women were screened for symptoms of depression both during and after pregnancy with the Edinburgh Postnatal Depression Scale (EPDS). A score of 13 or higher on the 10-item, Likert scale questionnaire is considered a high level of depressive symptoms.
Mean age of the 2390 G0 women in the study was 22.1 years. Of them, 408 (17%) had high depressive symptom scores. Forty-five of 180 G1 women included in the analysis (mean [SD] age, 22.8 [1.3] years) had high depressive symptom scores. The majority of G1 pregnancies were in the original female ALSPAC participants (163 of 180 [90.5%]), with the remaining 17 (9.5%) pregnancies being pregnant female partners of ALSPAC-G1 male participants. The ALSPAC-G1 cohort was more likely to have achieved higher education levels and take antidepressants than their mother’s generation, but they were less likely to smoke.
In unadjusted Poisson regression, the likelihood of having probable depression (EPDS score ≥ 13) during pregnancy was 1.51 times higher in the second generation of mothers than in the first generation of mothers (RR, 1.51; 95% CI, 1.15-1.97). When the researchers adjusted for age, BMI, smoking, nulliparity, and education, the strength of the association increased to 1.77 (95% CI, 1.27-2.46). Prenatal depression in the mother (ALSPAC-G0) was associated with her daughter’s (ALSPAC-G1) depression.
Fifty-four percent of the G1 participants whose mothers were depressed during pregnancy were also depressed themselves, compared with 16% of depressed G1 participants whose mothers were not depressed prenatally (RR, 3.33; 95% CI, 1.65-6.67). The researchers used linear regression to determine that the overall EPDS scores of the second-generation participants were, on average, 0.96 (95% CI, 0.19-1.74) points higher than scores of the participants from the previous generation.
The researchers noted a few strengths and limitations of the study. Among the strengths were use of two generations within the same cohort who both lived in the same geographical area. The measures of depression were identical and the timing of the measures were similar. The study was limited by its small sample size, and the understanding that people with mental health problems are less likely to take part in research.
While more research is necessary to determine whether the results are replicable in a larger and more diverse population, the researchers believe their findings illustrate the need for better screening, resources, and follow-up to support young