FDA In Brief: FDA provides updates on ongoing postmarket activities for Essure device

FDA In Brief: FDA provides updates on ongoing postmarket activities for Essure device

The FDA has taken a number of actions over the last several years to monitor the safety of the Essure permanent birth control device and has regularly updated the public on these actions. The manufacturer, Bayer, voluntarily stopped selling and distributing Essure in the U.S. on December 31, 2018. Health care professionals could implant Essure up to one year from the date the device was purchased. In light of that deadline, the FDA is reminding health care professionals and facilities that all Essure units that have not been implanted should be returned to Bayer by the end of 2019 and they should contact Bayer immediately to return the devices. Today, the FDA updated its Essure postmarket surveillance (522) study webpage with the number of participants enrolled in the postmarket surveillance study that the FDA ordered the company to conduct in...

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