Safety concerns surrounding power morcellators have prompted lawmakers to team up with patient advocates and introduce new legislation. The Medical Device Guardians Act of 2016, which was introduced by U.S. Reps. Louise Slaughter, D-N.Y. and Michael Fitzpatrick, R-Pa., would require physicians to report any medical device problems to the U.S. Food and Drug Administration (FDA). Doctors already have to report problems with drugs, but not medical devices. Only hospitals and manufacturers are required to report medical device problems.
Under the new legislation, it would be easier for patients to file lawsuits over defective medical devices. The advocates are headed by husband-and-wife physicians, Hooman Noorchashm and Amy Reed. Dr. Reed brought morcellator safety risks to the public sphere when she shared her personal story in 2013. They were the first people to file an official complaint with the FDA about the cancer-spreading risks of power morcellators in gynecologic procedures.
Power morcellators are used to cut up tissue into smaller pieces. They are used in minimally invasive gynecologic procedures such as a hysterectomy or myomectomy (uterine fibroid removal). However, these devices can greatly worsen, or “upstage” an undetected uterine cancer in some women. Before Amy went public with her story, the chances of this type of uterine sarcoma was believed to be rare; 1 in 10,000. However, after the couple began investigating the literature, they found that the risk is substantially greater. They now make it their mission to get the device banned and raise awareness.
In 2014, the U.S. Food and Drug Administration (FDA) discouraged the use of power morcellators in laparoscopic gynecologic procedures. The agency estimated that 1 in 350 women undergoing a procedure for fibroid removal suffered from an unsuspected uterine sarcoma, which cannot be reliably detected before surgery.
“What should [have] been a routine procedure has ended with a death sentence,’’ Slaughter said, according to USA Today. The Government Accountability Office has agreed to investigate power morcellators, in response to a request from Slaughter.
“While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,’’ Fitzpatrick said according to USA Today, “we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.’’
Johnson & Johnson has settled over 100 morcellators lawsuits alleging the device spread cancerous tissue. The company pulled its Ethicon morcellator from the market in July 2014.