ASHES, a nonprofit organized by a group of women raising awareness about medical devices and advocating for those who have been injured by them, are urging women to write the Food and Drug Administration (FDA) and their Congressmen to revoke the premarket approval (PMA) for the permanent birth control device Essure so that women injured by the contraceptive device can seek compensation for their injuries.
Essure was approved by the FDA in 2002 and remains the only nonsurgical permanent birth control method on the market. The device, made by Bayer Healthcare, consists of two nickel alloy coils that are inserted into the fallopian tubes, where they work with the body to form a barrier that prevents sperm from reaching the egg.
Essure has since been linked to thousands of complications including allergic reactions, severe pain and infections. There have also been cases of the coils migrating and perforating the fallopian tube or uterine wall, or embedding in other organs, often requiring hysterectomy or surgical removal.
“The Essure birth control device currently falls under Federal preemption laws. This essentially means that the manufacturers cannot be sued over an FDA approved device. However, efforts are being made by many persons working on your behalf to develop legal theories and pleadings in an attempt to circumvent preemption, and more importantly to have Essure’s premarket approval revoked and therefore preemption lifted,” ASHES states in a Call to Action release.
“However, we need your help and your voice,” the release states, urging women to contact the FDA and their congressional representatives to demand the FDA revoke the PMA granted to Essure. “Bayer is a powerful opponent, but together we are stronger.”
Source: Ashes Nonprofit