The FDA Provides An Update on Essure

Today, the U.S. Food and Drug Administration (FDA) posted updates about our ongoing postmarket activities related to Essure, a permanently implanted birth control device for women that, after December 2019, has no longer been available for implantation in the U.S.

The updates include:

  • Posting of 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.
  • Approval of Bayer’s (the company that manufactured Essure) revised 522 study protocol to include an additional interim analysis at one year after patients’ permanent birth control procedure.
  • Posting of the second spreadsheet of adverse event reports pertaining to information received from certain social media sources, in relation to ongoing litigation about this device. Bayer will continue to provide monthly spreadsheets of reports through April 2021. The FDA will post future spreadsheets on the “Problems Reported with Essure” webpage after the information is received from Bayer and reviewed by the FDA.

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

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