Update: Essure Postmarket Study Information

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FDA - Center for Devices and Radiological Health

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Update on Postmarket Study Information for 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 United States 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 updates on interim results from two postmarket studies on Essure. The updates include:

  • An additional year of follow-up data for Essure device removal. The FDA continues to monitor data from this ongoing Essure post-approval study to gain a fuller understanding of device removals over time.
  • Interim results from the FDA-required postmarket surveillance (“522") study, after all patients have completed one year of follow up.
    • Five-year follow-up of patients in the study is ongoing. The next interim analysis of study results is planned after all patients complete three years of follow-up. Final analyses of endpoints will not be completed until the study concludes.

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If you have questions about Essure, contact the Division of Industry and Consumer Education.