Essure: Update on Adverse Event Reports

New spreadsheet and analysis report available for adverse events.

If your email program has trouble displaying this email, view as a webpage. Update on Adverse Event Reports Associated with Essure The U.S. Food and Drug Administration (FDA) remains committed to provide updates on the safety profile of Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation in the U.S. since December 2019, the FDA continues to monitor the product's safety through an FDA-required postmarket surveillance study and other activities. Today, the FDA is providing an update on the ongoing postmarket evaluation of Essure. The update includes posting the ninth monthly spreadsheet of adverse event reports received by Bayer (the company that manufactured Essure) as required in the April 24, 2020, variance from Medical Device 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. Additionally, today Bayer posted its third quarterly analysis report of the adverse event information included in the variance reporting spreadsheets for the reporting time period of December 2020 through February 2021. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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