FDA In Brief: FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device

FDA In Brief: FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device

The FDA today updated its Essure website to include an analysis of medical device reports received in 2018. The FDA received approximately 6,000 medical device reports in 2018 related to Essure, which is a decrease from the nearly 12,000 medical device reports received by the FDA in 2017 but similar to the number received in 2015 and 2016. As in 2017, most of the reports received by the FDA in 2018 were submitted by Bayer and are related to litigation against the company, and most of the reports mention potential device removal. This information contributes to the FDA’s ongoing analysis of medical device reports that the agency conducts to better inform its understanding of device removal, which usually requires a surgical procedure.

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