A Republican congressman is working to put an end to the damaging permanent sterilization device known as Essure. Congressman Mike Fitzpatrick, R-P.A., has proposed the E-Free Act, a bill that hopes to revoke Essure’s FDA approval and remove it from the market.
Essure, Bayer HealthCare’s best-selling birth control device, has been linked to more than 5,000 injuries. The bill, known as the E-Free Act, focuses on safeguarding women’s health and improving medical device regulation.
Essure is a nickel-based metal coil marketed as a safer alternative to tubal ligation. The metal coil is inserted into a woman’s fallopian tube, creating scar tissue that prevents pregnancy.
The Food and Drug Administration (FDA) approved the sterilization device on Nov. 4, 2002, through a stringent process known as premarket approval. Rep. Fitzpatrick has proposed the E-Free Act as an attempt to highlight how the permanent sterilization coil has changed lives.
The device has been linked to at least four deaths and five fetal deaths, in addition to thousands of painful side effects. The bill asserts that Essure can cause “extreme pelvic and abdominal pain, bleeding, migraines, allergic and hypersensitivity reactions to nickel, autoimmune reactions, loss of teeth and hair, the metal coil breaking and migrating throughout the body, and the coil cutting into the uterus and other organs in the abdominal cavity.”
The act would assist in keeping thousands of women safe from the dangers of devastating medical devices. More than 24,000 women injured by Essure have joined together to share their stories, taking action against the medical device, and calling for medical injury compensation.