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A number of lawmakers are calling for the FDA to force Bayer to issue a recall for the Essure birth control implant, calling for the agency to withdraw its original approval amid reports of complications and problems experienced by women.
Representative Mike Fitzpatrick, a Republican from Pennsylvania, has said he intends to soon introduce the E-Free Act (PDF) in the U.S. House of Representatives. If approved, it would revoke the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002. This would require Bayer, who currently owns and distributes the birth control implant, to remove Essure from the U.S. market.
Fitzpatrick has support from Democrat Rosa DeLauro, a Connecticut Congresswoman who wrote a letter to the FDA (PDF) on October 9, also calling for an Essure implant recall.
Essure is form of long-acting birth control offered as an outpatient procedure by many medical facilities, where 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.
The calls to recall Essure come on the heels of a September 24 meeting of the FDA’s Obstetrics and Gynecology Devices Panel, which was focused on the safety concerns surrounding the birth control implant and reports of Essure complications suffered by a number of women who received the device. The hearing was marked by a parade of women who gave passionate testimonies on the damage the Essure implants have allegedly done to their bodies and their lives.
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.
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.
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.
“A citizen petition filed on behalf of hundreds of women injured by Essure asks FDA to remove the device from the market,” Rep. DeLauro noted in her letter. “FDA should take immediate action to do so.”
DeLauro also asked the agency a number of pointed questions about how the hearing was conducted, seeking information on why a panel of women who had actually participated in the Essure clinical trials were not allowed to report to the panel. Had they been allowed, according to DeLauro, their public testimony would have indicated that Essure’s sponsors changed patient ages and information on the Essure complications they suffered when they submitted the data to the FDA for approval.
DeLauro also noted that independent experts were not given sufficient time, and that the FDA has only posted 11 out of more than three thousand comments submitted to the docket of the citizen’s petition calling for an Essure recall.
“Essure’s benefits do not outweigh its risks, and it should be withdrawn from the market,” DeLauro said. “If well-designed studies in the future indicate that the benefits outweigh the risks compared to alternative permanent or long-term contraception, the FDA can consider approving Essure at that time.”