Power morcellators are surgical devices used to mince up tissue during a minimally invasive surgery, such as a laparoscopic hysterectomy. By cutting up the tissue into smaller pieces, surgeons can remove it more easily through small incisions. However, power morcellators have come under scrutiny during gynecologic procedures because there is a risk that they can spread hidden uterine cancers.
Morcellators are sometimes used to removed uterine fibroids, benign growths in the uterus. When the fibroids are cut up they are vacuumed out through a tube. In some instances, however, a presumed fibroid is actually an undiagnosed cancer known as a uterine sarcoma. These cancers cannot be reliably detected prior to surgery, and morcellating the cancerous tissue can greatly worsen patient’s prognosis.
Morcellators became a public safety issued after Dr. Amy Reed went public with her morcellator-linked cancer in 2013. In April 2014, the FDA issued a safety alert warning that power morcellators could spread hidden cancerous tissue. The agency placed a “black box” warning on the device. The Government Accountability Office is now investigating the issue and numerous lawsuits have been filed.
Concerns over power morcellator risks prompted lawmakers to propose a new bill known as the “Medical Device Guardian’s Act”. U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) proposed the legislation following the delayed awareness surrounding power morcellators. The lawmakers stated, in reference to Dr. Reed, that it should not have fallen on the patients to shed light on safety concerns. The bill would require doctors to report serious injuries and deaths related to medical devices. Doctors are encouraged to report deaths and serious injuries to the FDA, but it is not mandatory. The agency only requires this of device manufacturers and hospitals. Under the proposed bill, doctors and their offices would be added to the list of mandated reporters. The sponsors of the bill say it prevents these reports from being used against them in a civil lawsuit.