RICHMOND, Va. (WRIC) — Legislation, which is to be introduced by Pennsylvania Congressman Mike Fitzpatrick, calls for revoking the premarket approval Essure received from the FDA back in 2002. 8News Investigator Kerri O’Brien got her hands on draft legislation called the E-Free Act.
If passed, the bill calls for removing the approval within 60 days.
An earlier 8News investigation revealed the FDA has received more than 5,000 complaints about Essure ranging from allergic reactions to perforations of the uterus to even death.
“Essure’s benefits do not outweigh the risk and it should be withdrawn from the market.”
Rep. Fitzpatrick is not the only Congress member calling for action. Connecticut Congresswoman Rosa Delauro has written a letter to the acting FDA Commissioner saying she is “deeply concerned about the severe adverse health effects of Essure.”
She goes on to say, “Essure’s benefits do not outweigh the risk and it should be withdrawn from the market.”
Bayer, the makers of the birth control device continue to stand by the product. Bayer issued a statement to 8News saying in part:
“The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.”
An FDA advisory panel has recommended limited use of Essure. The FDA has yet to make a decision.
Rep. Fitzpatrick plans to introduce his bill in the next few weeks. Stay with 8News for updates.