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# Essure Postmarket Study ‘Inadequate’: FDA
- URL: https://www.fdaweb.com/essure-postmarket-study-inadequate-fda/
- Published: 2022-10-06T12:00:00.000Z
- Updated: 2026-09-14T18:02:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152905

FDA says it has changed the status of the Bayer Essure postmarket surveillance study to “progress inadequate.” A 10/6 Essure information [update](https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the status change for the birth control device study is due to the increase in interim lost to follow-up rates in both the Essure and laparoscopic tubal sterilization groups from the previous database lock.

“Per the study protocol,” the update says, “if a patient misses a follow-up visit but returns later and wishes to continue participation in the study, they will no longer be considered lost to follow-up. FDA requested Bayer develop and implement additional strategies to improve follow-up rates in the study.”

FDA also says it updated the Essure information Web page for patients and healthcare providers with the most current postmarket study information about device removal.