Mike Fitzpatrick, a Republican congressman from Pennsylvania, and Louise Slaughter, a Democratic congresswoman from New York, have teamed up to take on dangerous medical devices used in women's health procedures. Ariel Grace's Law and the Medical Device Guardians Act both hope to improve medical device safety across the board.
In June 2016, Fitzpatrick and Slaughter introduced two new congressional bills in a strong bipartisan effort focused on improving medical device safety. The bills are linked to two dangerous medical devices, Essure and morcellators.
Essure, a permanent birth control coil, caused more than 25,000 women to experience side effects like pain, bleeding, weight gain, punctured organs, and compromised immunities. Laparoscopic power morcellator procedures, used to remove uterine fibroids, have activated and spread undetectable uterine cancer cells. Many women treated with these devices have faced severe side effects, drastic changes in quality of life, and even death.
Medical Device Safety: Ariel Grace's Law
The Food and Drug Administration (FDA) permitted a number of drugs and devices to enter the market through a stringent premarket approval program. The first bill, H.R.5403, would amend the Federal Food, Drug, and Cosmetic Act to Fitzpatrick’s, allowing those harmed by premarket medical devices to file lawsuits.
"While the PMA is supposed to be the FDA’s ‘gold standard’ of safety, I think we all understand that even the most well-intentioned federal bureaucracies aren’t perfect — and it’s obvious this process has failed in some instances, yet for those impacted there is no option," Fitzpatrick told the House Rules Committee.
In 2008, the Supreme Court's decision in Riegel v. Medtronic limited the reach of legal assistance for people injured by premarket devices. The proposed law, named for a baby stillborn from a placental abruption, comes after Essure has been linked to hundreds of device failures, fetal deaths, and debilitating side effects.
Medical Device Safety: Medical Device Guardians Act
Hospitals and manufacturers are required to report injuries and deaths caused by medical devices to the FDA, but doctors and doctors' offices are held to no such standard. The second bill, H.R.5404, would mandate that doctors share information about harm caused by medical devices to the FDA.
Directly related to the controversy surrounding morcellator procedures, the law works to improve communication between doctors and the FDA. Dr. Amy Reed, an anesthesiologist who developed cancer after a morcellator hysterectomy, was the first to report the dangers of morcellators to the FDA. Despite her medical background, Reed was not informed about the uterine cancer risk.
“I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price,” Fitzpatrick said in a news release. “It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety."