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Dozens of women attended an FDA advisory committee meeting on Thursday, with more than 20 testifying and urging federal drug regulators to issue a recall of the Essure birth control implant.
Women described a litany of harmful Essure complications and ailments that they believe were caused by side effects of the controversial implant. The group applauded when members of the Obstetrics and Gynecology advisory committee expressed concern over the device or grilled Bayer executives on shortcomings in the Essure clinical trials during the hearing.
While the former users of the birth control who attended called for an Essure recall, the advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.
At this point, according to Bayer, more than 750,000 women in the U.S. have already undergone the procedure to have Essure implanted, and officials for the birth control maker stood by the safety and effectiveness of the birth control device.
The advisory committee’s recommendations are not binding, however the FDA often heavily weighs those recommendations in its final decisions.
Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
In June, the FDA scheduled a meeting of their independent advisory committee to evaluate the safety of Essure, after noting that the agency received at least 5,093 adverse event reports involving the device between it’s approval in November 2002 and May 31, 2015. Most of those reports were voluntary from women who received the implants.
According to the FDA adverse event reports, 3,353 of the incidents involved abdominal pain from Essure, 1,408 involved of menstrual irregularities, 1383 involved headaches, 966 were reports of fatigue, 936 were reports of weight fluctuation, and there were four reported deaths.
While clinical trials done by Bayer showed Essure to be safe and effective, the number of adverse event reports, and growing protests by women who say they have been injured by the device, has the FDA concerned enough to call for this week’s hearing.
An editorial published in the New England Journal of Medicine on Wednesday ahead of the hearing, points out that the Essure safety hearing comes 13 years after the device was allowed on the market. The concerns over the implant point to failings of the FDA’s premarketing and postmarketing evaluations, the writers said.
“Although Essure is designed to remain in place for a woman’s lifetime, few women in the premarketing studies were followed for more than 1 year — a limitation that precludes conclusions about longer-term risks,” the editorial states. “Appropriately, FDA approval was conditional on two mandatory postaapproval studies to provide 5-year follow-up data on patients in the premarketing approval studies. However, these studies were not made well known: neither one was registered at ClinicalTrials.gov….and their results were not disseminated in a timely way.”
The editorial notes that what data is available paints an uncertain picture of the device. They also said that the controversy surrounding Essure should be a lesson to shore up the requirements for approval for medical devices before they are exposed to the public.
“Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the premarketing-approval evaluation indicated,” the journal noted. “The problems of inadequately rigorous premarketing and postmarketing studies, unregistered clinical trials, and incomplete and delayed dissemination of results are not unique to Essure.”