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December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure. In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.
On July 20, 2018, Bayer announced that it would discontinue sales and distribution of its Essure permanent birth control device after December 31, 2018.
Prior to this announcement, the FDA required Bayer to add a boxed warning to the labeling of Essure and issue a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks and the sales restriction that FDA placed on the product.
FDA oversight will continue even after sales and distribution of the device has stopped. The FDA’s oversight of the device includes requiring that Bayer complete the postmarket surveillance study that was ordered in February 2016.
“As part of the revised protocol for the postmarket surveillance study, the FDA has worked with Bayer to see that the manufacturer implements several approved modifications to the study that we believe will strengthen the evidence collected.”
Following Essure’s removal from the market, the FDA is committed to continuing to monitor women who have the device implanted.
Read the full FDA Statement.
Complications from the Essure device are migration and perforation of the fallopian tubes, which can puncture the uterus and other organs. If you have suffered serious complications due to an Essure device, contact one of our attorneys for a free, no-obligation review of your situation.
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