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FDA Report: Pain, Menstrual Issues Most Common Essure-Tied Adverse Events

 
• By Elizabeth Orr

The US agency has released data on nearly 50,000 adverse events related to Bayer’s withdrawn Essure birth control implant.

ESS305 hand40v2 small
• Source: Bayer AG

The US Food and Drug Administration received almost 50,000 adverse event reports tied to Bayer AG’s Essure implantable birth control device between its 2002 approval and the end of last year, the agency said in recently released data.

The information includes 47,856 Medical Device Reports (MDRs) submitted between 4 November 2002 and 31 December 2019. The agency released the compiled information alongside a recent announcement that it was...

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More from Policy & Regulation

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