FDA Women's Health

Enrollment has ended in Essure postmarket study, FDA says

Dive Brief:

  • FDA on Friday announced that enrollment in a postmarket study of the discontinued Essure permanent birth control implant has concluded.
  • The study, which FDA directed manufacturer Bayer to extend from three years to five to better understand complications associated with the device, enrolled a total of 340 women in the Essure group and 788 in the laparoscopic tubal ligation arm.
  • Bayer stopped selling the device in the U.S. at the end of 2018, following tens of thousands of reports of complications ranging from pain to device migration and breakage as well as 49 deaths linked to the implant.

Dive Insight:

Bayer ended sales of Essure in July 2018 as demand for the product declined amid the growing number of adverse event reports. FDA had already restricted sales of the device several months before the company’s decision to take it off the market, though Bayer continued to defend the product’s safety.

Nearly 50 deaths were linked with the device, though FDA has said it is difficult to determine whether the implant caused those deaths.​ Most of the more than 32,000 medical device reports related to Essure that were analyzed by the agency from 2002 through 2018 described pain, menstrual irregularities, rash, device migration, breakage or fragmentation, and implant failure or pregnancy.

Before Bayer exited the market, FDA had required the company to conduct a postmarket study, beginning in 2016, that initially aimed to compare 1,400 Essure patients with 1,400 patients who underwent laparoscopic tubal ligation for sterilization. Those plans had to be scaled back, however, after the company withdrew from the market.

FDA’s latest figures on the study’s enrollment are up somewhat from an update the agency gave as of Sept. 1, when it said 329 women had enrolled in the Essure arm and 673 in the tubal ligation group.

In its latest communication, FDA said Bayer has been successful in retrieving unused devices from healthcare providers in inventory, having gathered over 99% of unused devices from the market. The agency said just 10 devices remain in the field, and the company is actively seeking to have them returned to ensure they are no longer available for implant.

FDA said it would publish interim study results, including information about device removal, once the data are analyzed, and in general will ​continue to provide updates about Essure as new information becomes available.

“Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

 

Original Article: (https://www.medtechdive.com/news/enrollment-has-ended-in-essure-postmarket-study-fda-says/570287/)

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