March 15, 2021
The following quote is attributed to Courtney H. Lias, Ph.D., acting director of the Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices in FDA’s Center for Devices and Radiological Health:
“Today’s update on the annual evaluation of adverse event reports associated with Essure is part of the FDA’s continuing commitment to regularly communicate with patients and health care providers to provide up-to-date information about this permanent birth control device.
Even though this device is no longer sold or being implanted in women, 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 post-market surveillance of safety concerns even after a device is removed from the market."
- The FDA today updated its website to include its annual analysis of medical device reports received from Nov. 4, 2002 – Dec. 31, 2020 in relation to Essure, a permanently implanted birth control device for women that has not been available for implantation since December 2019. In 2020, the FDA received 16,086 medical device reports related to Essure, an increase from the 15,083 medical device reports received in 2019. As in 2019 and recent years, most of the reports received by the FDA in 2020 were submitted by Bayer (the company that manufactured Essure) and more than 90% are related to litigation against the company. Litigation reports may reference information previously submitted to the FDA.
- As in past years, most of the adverse event reports mention potential device removal (93.5%). This information contributes to the FDA’s ongoing evaluation of postmarket data and helps better inform FDA’s understanding of device removal, which usually requires a surgical procedure.
- Also today, as part of its ongoing update on the variance reports, the agency posted the seventh spreadsheet of adverse event reports received by Bayer as required in the April 24, 2020 variance from MDR reporting requirements. These events are from social media in connection with litigation, may reference information already reported to the FDA, and do not necessarily represent new adverse events. In addition, Bayer posted its second quarterly analysis report of the adverse event information included in the variance reporting spreadsheets, reported between September 2020 through November 2020.
- Over the last several years, the FDA has taken a number of actions to monitor the safety of Essure. The agency regularly updates the public about these actions and remains committed to sharing new information as it becomes available.
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.