Essure: Updates on Adverse Events Reports

Bayer posts second quarterly analysis report.

If your email program has trouble displaying this email, view as a webpage. The FDA Provides Updates on Adverse Event Reports Associated with Essure The U.S. Food and Drug Administration (FDA) remains committed to collecting and providing updates on the long-term safety information about Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA continues to monitor the product's safety through postmarket surveillance study data and other activities. Today, the FDA is providing updates on the ongoing postmarket evaluation of Essure. The updates include posting: Updated information on Medical Device Reports (MDR) received by the FDA related to Essure in 2020. The seventh spreadsheet of adverse event reports received by Bayer (the company that manufactured Essure) as required in the April 24, 2020 variance from MDR 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. Today, Bayer also posted its second quarterly analysis report of the adverse event information included in the variance reporting spreadsheets, which are for the reporting time period of September 2020 through November 2020. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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