FDA provides updates on discontinuation of Essure and ongoing postmarket activities

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-provides-updates-discontinuation-essure-and-ongoing-postmarket-activities?utm_campaign=FDA%20provides%20updates%20on%20discontinuation%20of%20Essure%20and%20ongoing%20postmarket%20activities&utm_medium=email&utm_source=Eloqua

Message from the Associate Commissioner for Women’s Health

Dear Women’s Health Colleagues,

Today, we are sharing a statement regarding the discontinuation of the Essure birth control device and ongoing postmarket activities. Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency. We will continue to share updates on behalf of the agency as they are available. Please read the full FDA statement below.

Sincerely,

Kaveeta Vasisht, M.D., Pharm.D.

Associate Commissioner for Women's Health

FDA provides updates on discontinuation of Essure and ongoing postmarket activities 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. Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today FDA announced 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. Read the full FDA in Brief Statement