FDA has updated its Essure Web page with information on medical device reports about Essure received in 2018. The agency says it continues to post the latest information about Bayer’s postmarket surveillance study on the 522 study Web page. The company withdrew Essure from the market at the end of 2018.
FDA says it received about 6,000 medical device reports in 2018 related to Essure, down from the nearly 12,000 received in 2017, and about the same as in 2015 and 2016.
The update to the study Web page includes the number of participants enrolled in the postmarket surveillance study that FDA ordered Bayer to conduct in 2016. As of 4/1, it says, there were 891 patients enrolled in the study, with 307 enrolled in the group who elected Essure and 584 in the group who elected laparoscopic tubal ligation. FDA says it considers this to be adequate progress.