FDA Rebuts Activists: Essure Study is Underway

In response to a request for comment on activists’ complaints yesterday that Bayer had not begun a promised study on patient experience with its controversial Essure permanent contraceptive implant, FDA told FDA Webview 6/8 that it approved the study plan 9/2/2016, and Bayer has since begun the postmarket study. “As of 5/3, 60 sites had been selected for participation, 31 sites had submitted IRB applications, 24 sites had central IRB approval and three sites had been enrolled, it said. As of 5/3, one patient had been enrolled in the study. Site and patient enrollment is a continuous process.”

The agency noted that a publicly available Web page has been set up to keep all stakeholders informed of the progress of each postmarket surveillance study. It displays general information and the status of each study (based on protocol-driven timelines and adequacy of the data). A one-year study report is due 9/2, and FDA intends to provide an update after the next interim report.