Essure study results could take years

RICHMOND, Va. (WRIC) — Thousands have shared their horror stories with using the controversial birth control device Essure.

“Both of my Essure implants migrated and were perforating my uterus,” Christine Cervantes told 8News.

Now 8News is learning it could be another seven years before women like Cervante see the results of an FDA ordered study of the medical device.

The Food and Drug administration recently approved Bayer’s postmarket surveillance study of Essure, however, the final report isn’t due until 2023. That has one Congressman fired up and now calling for a Congressional hearing.

Pennsylvania congressman Mike Fitzpatrick is asking congress for a hearing on the safety of medical devices like Essure and what he calls “the failings of the U.S.Food and Drug Administration.”Essure has been linked to 4 adult deaths and 8News uncovered the FDA has received 10,000 reports of serious problems with the device.

Essure has been linked to 4 adult deaths and 8News uncovered the FDA has received 10,000 reports of serious problems with the device. Yet, the FDA has not pulled the device from the market.

Instead, the agency required Bayer to add a black box warning — the most serious of label warnings — to the device and the FDA also called on the manufacturer Bayer to conduct that surveillance study. Fitzpatrick worries others will be harmed in the years it takes to get the results of that study.

In his letter to the Committee on Energy and Commerce, Fitzpatrick writes:

“Congress cannot ignore the voices of those harmed by unsafe medical devices. We must allow them to tell their stories, present their innovative policy solutions, and help us bring our medical device safety laws into the 21st century.”

Six other Congress members have signed on to the letter. Fitzpatrick’s office tells they have yet to hear anything back.

This is a developing story. Stay with 8News online and on air for the latest updates.

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