WASHINGTON (KXAN) — A bill aimed at helping women suffering from Essure, a permanent birth control device, was introduced on the House floor Wednesday afternoon.
Ariel Grace’s Law was filed in an effort to hold the manufacturer liable for any injuries or deaths related to the use of Essure. A second bill filed called the Medical Device Guardians Act also hopes to give physicians a better avenue to report issues about medical devices to the Food and Drug Administration.
Essure is a device that is inserted into a woman’s fallopian tubes. Within three months, scar tissue grows around the coils creating a barrier that prevents sperm from reaching the eggs. According to the company’s website, most women go home 45 minutes after the procedure.
Members of the House heard testimony from women who claim the implant has caused them physical and emotional pain.
“The women of Essure problems have beseeched the FDA, our doctors, anyone to help us. And in desperation we finally turned to congressional representatives,” said Tess Schulman, who has had suffered ailments she claims are from Essure.
Rep. Mike Fitzpatrick, who introduced the bills, says it should not have been up to the patients to bring the issues up to the FDA’s attention.
In November, a bipartisan group of U.S. lawmakers introduced the E-Free Act (H.R. 3920) in hopes of pulling Essure off the market but that bill has not had much movement in the House.
According to FDA records, approximately 10,000 complaints have been filed complaining about health complications related to the use of Essure. Records show most women reported pain/abdominal pain, menstrual irregularities headaches and fatigue. The agency says some people reported more than one problem.
The FDA’s website states, “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”
On Sept. 24, 2015, the FDA held hearings on the growing number of complaints regarding the adverse effects of Essure. Doctors and patients testified about their experiences with the permanent birth control device.
After the hearing, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks. The agency also drafted a boxed warning to make sure a woman knows the risks associated with the product and a patient checklist that doctors review with a woman to make sure she understands the benefits and possible health complications.
The manufacturer of Essure, Bayer, still claims the birth control option is safe for most women and the benefits outweigh the risks.