November 4, 2019
“Even though the Essure device is no longer sold in the U.S., the FDA is committed to continuing to monitor the postmarket safety of the device for women who have the device implanted. Today, we are providing an update on our ongoing postmarket activities related to Essure, so that patients and health care professionals have up-to-date information on this device,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is also reminding health care professionals and facilities that before the end of this year, all Essure devices that have not been implanted should be returned to Bayer. We remain committed to collecting long-term safety information and ensuring that Bayer continues to meet its mandated postmarket study obligations beyond 2019. We’ll continue to communicate with patients and health care professionals about Essure as new information becomes available.”
The FDA has taken a number of actions over the last several years to monitor the safety of the Essure permanent birth control device and has regularly updated the public on these actions. The manufacturer, Bayer, voluntarily stopped selling and distributing Essure in the U.S. on December 31, 2018. Health care professionals could implant Essure up to one year from the date the device was purchased. In light of that deadline, the FDA is reminding health care professionals and facilities that all Essure units that have not been implanted should be returned to Bayer by the end of 2019 and they should contact Bayer immediately to return the devices.
Today, the FDA updated its Essure postmarket surveillance (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 September 1, 2019, 1,002 patients have been enrolled in the study, with 329 enrolled in the group who elected Essure and 673 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 patient complications in the long term. The FDA believes clinical data from this 522 study will help patients, health care providers, and the agency to better understand certain patient complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. At the end of this year, enrollment in the 522 study will be complete. 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.
In addition to the 522 study, the FDA continues to monitor other sources of postmarket data, including ongoing Essure post-approval studies and adverse event reports. Today the FDA updated information about Essure device removal. The FDA continues to monitor data from an ongoing Essure post-approval study to gain a fuller understanding of device removals over time and will continue closely monitoring device removals in the 522 study to gain greater knowledge of this issue. The agency has also updated the evaluation of adverse events reports related to device removal to include those submitted in the second half of 2018.
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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.