Bayer to Stop Essure Birth Control Device Sales
Bayer has announced they will discontinue selling Essure, its controversial implantable birth control device at the end of the year. Essure has been under severe scrutiny by the FDA which has received thousands of serious adverse event reports and has issued numerous warnings regarding the device. Bayer is also facing thousands of lawsuits by women who claim the device has resulted serious injury including perforation of the uterus or fallopian tubes.
Essure was introduced in 2002 and marketed as permanent, non-surgical birth control which could be implanted during a minor procedure in a physician’s office. By 2017, over 27,000 serious adverse event reports had been filed with the FDA. In April, the FDA required that Bayer limit sales to doctors’ offices and medical clinics which agreed to “fully inform” women about the risks which include potential for device migration into abdominal or pelvic cavity, requiring surgical removal.
The new requirement followed a 2016 advisory event in which a number of women testified before the Agency regarding the injuries they had suffered after Essure implantation. The FDA declined to recall Essure but issued a “black box warning” which increased safety warnings and required a Patient Decision Checklist. In 2017, Bayer suspended sales in the E.U. over similar regulatory concerns but had continued to sell the device in the U.S.
Bayer has said that the decision to discontinue U.S. sales at the end of 2018, is a commercial decision, based on declining sales. The company blames lackluster sales figures on “inaccurate and misleading publicity” and claims that American women are now less interested in permanent contraception, preferring reversible or short term options. Bayer states that they stand behind the safety of the device and the “benefit-risk profile of Essure” has not changed.
Essure is constructed of two coils made of nickel-alloy and a polyester, which are implanted through the vagina. Their placement is intended to produce and inflammatory response which causes scar tissue to form and block the fallopian tubes.
Since its introduction, many concerns have been raised regarding a lack of adequate safety data and a high number of serious injury reports. Thousands of women have filed lawsuits against Bayer for injuries that have been attributed to implantation of the device.
The FDA has stated that they will work to ensure that postmarketing surveillance is continued and that Bayer meets its postmarket obligations regarding safety.
Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed, U.S. Food and Drug Administration (7/20/2018)