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.