FDA asks for more studies on Bayer’s Essure birth control device

Logo of German drugmaker Bayer is seen in LeverkusenThe U.S. Food and Drug Administration has asked German drugmaker Bayer AG to conduct further studies on its controversial birth control device, Essure, and recommended that the product label contains the most restrictive type of warning. Essure, acquired by Bayer in 2013, has been the target of thousands of complaints and calls for its withdrawal since it was approved for sale in the United States in 2002. The FDA has instructed Bayer to conduct a clinical study to determine heightened risks for some women and has issued draft guidance with labeling recommendations, including a "black box" label warning of serious risks.

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