House legislation was introduced earlier this month seeking speedier action by federal regulators to remove dangerous medical devices from the market, such as power morcellators and the Essure medical birth control system.
The two bipartisan bills are expected to simplify the process for patients who have endured serious adverse reactions over faulty devices to sue the manufacturers of these devices, Cincinnati.com reported. The Medical Device Guardians Act of 2016 would mandate doctors to report problems caused by medical devices to the FDA, covering existing and future devices. The second bill would allow Essure’s maker—Essure is a permanent sterilization system that has been tied to the deaths of at least four women—to be held liable for patient harm.
The power morcellator, which has been used regularly in minimally invasive fibroid removal surgery and hysterectomies is constructed with “high-speed blades that cut tissue,” making the process of removing tissue easier through small incisions, wrote Cinncinati.com. The bill’s sponsors have said that serious health problems seen with power morcellator devices—including devices previously manufactured by Ethicon—prompted their proposal. Under today’s laws, hospitals and device makers must provide adverse reaction reports to the FDA; however, patient advocates argue that this law does not enable full reporting, according to Cinncinati.com.
U.S. Representatives Louise Slaughter (Democrat-New York) and Michal Fitzpatrick (Republican-Pennsylvania) co-introduced the legislation after they were both approached by constituents who gave very personal and persuasive accounts about how power morcellators led “otherwise treatable cancers to spread,” according to Cinncinati.com. Representative Slaughter said, “What should have been a routine procedure has ended with a death sentence” and asked the Government Accountability Office (GAO) to investigate why the FDA approved the power morcellator. The device chops the uterus and/or fibroids, which may be hosting malignant cancers that have not spread; however, once diced, the cancer may then spread to other parts of the body.
In April 2014, Johnson & Johnson suspended sales of Ethicon’s power morcellator and withdrew the device in July 2014. J&J, Ethicon’s parent company, settled more than 100 legal claims and lawsuits tied to power morcellators’ potentially cancer-spreading risks, co-lead counsel for a consolidated lawsuit against J&J told the Wall Street Journal, Cinncinati.com reported.
“All of us share a similar sad story,’’ said Frank Interlichia, whose wife died following serious adverse reactions from a morcellator procedure. Mr. Interlichia was speaking to some two-dozen patient advocates who traveled from around the nation to be there when the announcement of the proposed bill was made. He told the group it was his wife’s burning desire “to make sure this never happens to anyone else.’’
Married physicians, Hooman Noorchashm and Amy Reed, approached Representative Fitzpatrick after use of a power morcellator during Reed’s hysterectomy led her undetected cancer to spread. The two were the first to file an official complaint with the FDA in November 2013. “While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,’’ Fitzpatrick said, “we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health,’’ Cinncinati.com reported.
Neither bill has a Senate sponsor as yet; however, Representative Fitzpatrick believes the legislation will be considered by year-end.