MND, Nov. 3, 2015 ~ There has been a lot of organized attention by consumers harmed by the Essure birth control device made by Bayer Healthcare Pharmaceuticals.
Metal coils are implanted in the fallopian tubes with the goal of having them scar over, therefore preventing pregnancy. The coils contain polyethylene fibers and are held in place by stainless steel and nickel titanium alloy.
Approved in November 4, 2002 by the U.S. Food and Drug Administration, Essure has gathered thousands of complaints from women who report complications – autoimmune issues, pain, migrating metal, sensitivity to metal, pelvic inflammatory disease, uterine bleeding, and deaths of four women and five unborn children.
A bill filed Wednesday by Rep. Michael Fitzpatrick (R-PA), the E-Free Act, would force the FDA to pull Essure from the market. Rep. Rosa DeLauro (D-CT) has also asked the FDA to remove Essure from the market because its “benefits do not outweigh the risks.”
Read more here.
Rep. Fitzpatrick called this a “woman’s issue, a regulatory issue and a safety issue with faces and names.”
The Essure Problems Facebook page has organized its 22,000 members to be outspoken advocates for the 5,000 women who have filed adverse event complaints with the agency. Activist Erin Brockovich has brought attention to the issue.
See the video of Rep. Fitzpatrick here.
Essure birth control home page by Bayer is here.
An FDA advisory panel met in September and said Essure should remain an option for some women.