Regulatory Focus™ > News Articles > 2020 > 1 > FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete

FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete

Posted 10 January 2020 | By Michael Mezher 

FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete

In the latest update in the years-long investigation into the safety of Bayer’s permanent birth control device Essure, the US Food and Drug Administration (FDA) on Friday said that nearly all unused Essure devices have been returned to Bayer and that the company has wrapped up enrollment in an FDA-mandated postmarketing study.
 
Since Bayer announced it would stop marketing and distributing the devices in the US in July 2018, the company has sought to collect all remaining unused Essure devices from its customers. Bayer pulled Essure from international markets in September 2017.
 
“Bayer’s efforts to reach customers went through the end of 2019 and have largely been successful in retrieving the vast majority of unused Essure devices such that they are no longer available for implantation in the US,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, noting that the company is aware of just 10 unused devices remaining on the market.
 
Shuren also said that Bayer ended enrollment in its postmarketing study FDA required the company to conduct in February 2016. After Bayer’s decision to pull Essure from the market in the US, FDA approved a revised study plan that allowed the company to enroll fewer patients in the study but required five years of mandatory follow up instead of three.
 
According to FDA, Bayer ended enrollment with 1,128 patients participating in the study, 340 of whom received Essure and 788 who elected to undergo laparoscopic tubal ligation.
 
FDA says it will continue to post updates regarding Essure and will make interim study results available as they are analyzed and reviewed.
 
FDA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe