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# FDA Rebuts Activists: Essure Study is Underway
- URL: https://www.fdaweb.com/fda-rebuts-activists-essure-study-is-underway/
- Published: 2017-06-09T12:00:00.000Z
- Updated: 2026-09-14T22:28:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138896

In response to a request for comment on activists’ [complaints yesterday](https://www.fdaweb.com/fda-lax-in-essure-risk-warnings-advocates/) 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](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?ref=fdaweb.com) 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.