Essure Device: FDA Safety Oversight after Discontinuation of US Sales

• December 21, 2018
• FDA, Medical Devices

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.

FDA Oversight of Essure Device

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.”

• women in the study will be followed for five years, rather than the three years that was initially required. This extension will provide longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.
• requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. This could help better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.
• requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results.

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.

NEED LEGAL ADVICE?

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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