FDA In Brief: FDA provides updates on discontinuation of Essure and ongoing postmarket activities
January 10, 2020
The following quote is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health:
“While Essure devices have not been sold in the U.S. for more than a year, the U.S. Food and Drug Administration (FDA) engaged directly with Bayer to help to ensure that previously sold but unused devices were returned to the company by the close of 2019. Efforts included Bayer proactively reaching out to health care professionals and facilities to return unused Essure devices so that they would no longer be available for implantation.
“Bayer’s efforts to reach customers went through the end of 2019 and have been largely successful in retrieving the vast majority of unused Essure devices such that they are no longer available for implantation in the U.S. As of today, Bayer has reported to the agency that over 99% of unused devices have been returned. Bayer is aware of 10 unused devices that they are actively seeking to retrieve. They continue to process the returns and update the FDA on their efforts to obtain the remaining unused Essure devices.
“Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are announcing that enrollment in Bayer’s required postmarket surveillance study has ended. Follow-up of patients in the study is ongoing, and the FDA is committed to sharing new information with the public about the postmarket safety of this device as it becomes available. ”
- Essure is a permanently implanted birth control device for women (female sterilization) that was approved by the agency in 2002.
- The FDA has taken a number of actions over the last several years to monitor the safety of Essure and has regularly updated the public.
- The manufacturer, Bayer, voluntarily stopped selling and distributing Essure in the U.S. on December 31, 2018. In 2019, the agency reminded health care professionals and facilities to return unused Essure devices to Bayer.
- Additionally, Bayer has been actively reaching out to its customers to ensure the return of unused devices. As of December 31, 2019, Bayer has been largely successful in ensuring the vast majority of unused Essure devices have been returned, making them unavailable for implantation.
- Today, the FDA is providing an update that the enrollment period in Bayer’s required postmarket surveillance (522) study has ended.
- As of today, 1,128 patients have been enrolled in the study, with 340 enrolled in the group who elected Essure and 788 in the group who elected laparoscopic tubal ligation.
- As previously announced, the FDA instructed Bayer to extend the 522 study from three years to five years to better understand the device’s long-term safety profile.
- The FDA believes clinical data from the 522 study will help patients, health care providers, and the agency to better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation.
- The FDA will post the interim study results, including information about device removal, once the data are analyzed and the next report is reviewed. Findings from the study may serve to inform future FDA actions.
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.