Friday, July 20, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed

The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness.

The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.

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