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The U.S. Food and Drug Administration (FDA) remains committed to collecting information and providing updates on the long-term safety and effectiveness 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 (“522”) study and other activities.
Today, the FDA is providing an update from the ongoing evaluation of Essure. The update includes:
- The latest postmarket study information about device removals
- Information about medical device reports received in 2023.
Questions?
If you have questions about Essure, contact the Division of Industry and Consumer Education.
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