FDA Calls For Warnings, Study Of Permanent Birth Control

DENVER (CBS4) - Colorado women who say they have suffered as a result of a permanent birth control implant now say they are outraged by a decision made by the Food and Drug Administration.

Essure is a tiny coil designed to block the fallopian tubes and permanently stop pregnancy. Thousands of women across the country have complained about health problems after having the implant. In the last year, CBS4 has talked to more than a half-dozen Colorado who say they've suffered due to Essure.

In September 2015, the Medical Devices Advisory Committee of the Food and Drug Administration held a day-long hearing on the product. Panel members heard from Bayer Healthcare, the maker of Essure, medical professionals, as well as patients who've reported health problems after having the implant. The Colorado contingent felt vindicated.

"We're finally being heard. It's been a long battle ... years of trying to be heard," said Debra Logan in September at the time of the hearing.

They were hoping for a full recall of Essure.

On Feb. 29, the FDA issued a communication asking for a new postmarket study of patients with the implant. The agency is calling for new package labeling that will make the warnings more prevalent, and a Patient Decision Checklist. But the FDA stopped short of taking the product off the market.

ADDITIONAL RESOURCE: FDA Draft Guidance

In a press release issued on the Essure Problems website, opponents of the product promise to continue the fight. They say they'll take their concerns to Congress in an effort to force the FDA to do a recall.

ADDITIONAL RESOURCES: Essure Problems Reaction

Bayer Healthcare also issued a statement about the FDA communication. It says, "Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure."

Bayer has always maintained that Essue is safe and says that hundreds of thousands of women have the implant with no problems.

ADDITIONAL RESOURCES: Bayer Healthcare Statement

Libby Smith is a Special Projects Producer at CBS4. If you have a story you'd like to tell CBS4 about, call 303-863-TIPS (8477) or visit the News Tips section.