FDA In Brief: FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device
May 15, 2019
“As part of the FDA’s continuing commitment to regularly communicate with stakeholders about the permanent birth control device Essure, today we are providing an update on our ongoing postmarket evaluation of Essure, so that patients and health care professionals have up-to-date information on this device to help them make more informed health care decisions,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available. Our work to continually monitor the long-term safety profile of Essure is part of our broader effort to assure device safety, which includes ongoing actions to enhance our post-market surveillance system to identify and address new safety concerns once a device is on the market and to encourage innovations that lead to safer medical devices.”
The FDA today updated its Essure website to include an analysis of medical device reports received in 2018. The FDA received approximately 6,000 medical device reports in 2018 related to Essure, which is a decrease from the nearly 12,000 medical device reports received by the FDA in 2017 but similar to the number received in 2015 and 2016. As in 2017, most of the reports received by the FDA in 2018 were submitted by Bayer and are related to litigation against the company, and most of the reports mention potential device removal. This information contributes to the FDA’s ongoing analysis of medical device reports that the agency conducts to better inform its understanding of device removal, which usually requires a surgical procedure.
Today, the agency also updated the Essure 522 study webpage with the number of participants enrolled in the postmarket surveillance study that the FDA ordered the company to conduct in 2016. As of April 1, 2019, 891 patients have been enrolled in the study, with 307 enrolled in the group who elected Essure and 584 in the group who elected laparoscopic tubal ligation. The agency considers this to be adequate progress.
In light of Bayer’s decision to discontinue sales and distribution at the end of 2018, the FDA recognized that there would be challenges reaching the study’s initial sample size, because it relied on enrolling patients who were newly implanted with Essure until May 2020. To account for lower enrollment, the FDA worked with Bayer on a revised study plan to provide more long-term information regarding complications that may be experienced by patients, despite reduced enrollment. As part of the previously announced revised protocol for this study, participants will be followed for five years to provide longer-term information on the risks of the device, including issues that may lead women to have the device removed.
Bayer is required to continue enrolling new participants in its postmarket surveillance study as long as Essure is available in the U.S. Because health care providers may implant Essure up to one year from the date the device was purchased, the device will no longer be available after December 2019.
The FDA will post the interim study results once enrollment into the Essure arm of the study is completed. The data being collected is intended help the FDA to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. The agency is committed to collecting long-term safety information following the discontinuation of the device to better evaluate its safety profile when used in the real world.
The FDA has taken a number of actions over the last several years to ensure the safety of the Essure device. Beginning in 2015, the FDA convened a public meeting to learn more about how the agency could better investigate patient complaints like pain, heavy bleeding and device migration; a year later, the FDA ordered the company to conduct a postmarket surveillance study and approved labeling changes including a boxed warning that highlighted the device’s risks. In April 2018, the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness. Bayer stopped selling and distributing the Essure permanent birth control device in the U.S. on December 31, 2018, and, at the end of this year, health care professionals and patients will no longer have access to the device.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.