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FDA Received About 6,000 Reports on Bayer’s Essure in 2018

May 16, 2019, 3:09 PM

The FDA updated its Essure website on May 15, disclosing that it received about 6,000 medical device reports in 2018 related to Essure, a decrease from about 12,000 medical device reports received in 2017 and similar to the number received in 2015 and 2016.

  • As in 2017, most reports received by FDA in 2018 related to litigation against Bayer & most reports mention potential device removal
  • Agency also updated Essure 522 study webpage with number of participants enrolled in postmarket surveillance study, with 891 patients enrolled in study as of April 1, 307 enrolled in group who elected Essure & ...