The Essure permanent birth control device will no longer be sold or distributed after Dec. 31, 2018, in the United States.
Bayer, the manufacturer of Essure, notified the Food and Drug Administration of its decision to halt U.S. sales of the device, Commissioner Scott Gottlieb, MD, announced July 20 in a. Dr. Gottlieb added that the agency would continue its commitment to postmarketing review of Essure. “We expect Bayer to meet its postmarket obligations concerning this device.”
Since its approval, Essure is estimated to have been used by more than 750,000 patients worldwide, the FDA release stated. The device has been associated with serious risks, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.
“In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction, which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgment that they fully understood these potential risks before having the device implanted. Since the FDA ordered Bayer to conduct the postmarket study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70% decline in sales of Essure in the United States,” Dr. Gottlieb said in the FDA press release. The company stated its decision to halt sales and distribution of the device was because of commercial reasons.
“Numerous adverse events ... were reported to the FDA, including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We’re continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.”
In September 2015, the FDA convened an expert panel to examine and follow up on complaints from Essure users that included abdominal pain, abnormal uterine bleeding, and device migration. In February 2016, the FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The following October, the agency issued the final guidance, “Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization.” Soon thereafter, the FDA approved updated labeling for Essure that added a boxed warning and a Patient Decision Checklist.
In March 2018, the FDA reported a rise in new medical device reports submitted to the agency’s public database in 2017, with more than 90% of the reports involving potential device removal. The April restriction of sales and distribution was in response to concerns that not every patient was receiving adequate risk information.
“I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Each study participant will be followed for a total of 3 years, and the company will continue to submit reports to the FDA on the study’s progress and results. Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we’ll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure,” Dr. Gottlieb stated.
He added that women who are using Essure successfully to prevent pregnancy should continue to do so, as “device removal has its own risks.”