FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Will Continue Overseeing Discontinued Birth Control Device

Jan. 3, 2019
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FDA Commissioner Scott Gottlieb announced additional agency plans to continue oversight of Bayer’s Essure birth control device, despite the product’s discontinuation in the new year.

Gottlieb said that the agency will extend the time it spends monitoring participants in Bayer’s post-market study from three years to five years.

The agency will also require blood tests of patients participating in follow-up visits during the post-market study to gather more information on certain markers that might be signs of increased inflammation.

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