Essure: Update on Adverse Event Reports

Final analysis report of adverse event information available.

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 providing updates on the safety profile of Essure, a permanently implanted birth control device for women. Although Essure 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 adverse event information 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. Bayer has completed the variance reporting and has met the requirements of the variance. Additionally, today Bayer posted its final analysis report of the adverse event information included in the variance reporting spreadsheets, which are for the reporting time period of June 2020 through March 2021. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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