Congressman Demands Criminal Probe into Power Morcellator Deaths
Congressman Mike Fitzpatrick of Pennsylvania is demanding that the U.S. Food and Drug Administration (FDA) investigate fatalities linked to power morcellators, devices used in laparoscopic hysterectomies and myomectomies. He not only wants the FDA to investigate Ethicon, a subsidiary of Johnson & Johnson that manufactures the device, he is also demanding the agency look into the protocols followed by three prominent hospitals.
The “Horrific Consequences” of Power Morcellators
Fitzpatrick recently sent a letter to the FDA stating that “hundreds, if not thousands” of women have died due to the use of power morcellators. He wrote that if manufacturers of the device, as well as hospitals, followed the proper protocol, women could have avoided what he termed the “horrific consequences” associated with morcellation.
Power morcellators are devices used during hysterectomies and myomectomies to remove benign growths called fibroids from the uterus and surrounding areas. Fibroids look extremely similar to tumors associated with a form of cancer known as uterine sarcoma. If a tumor appearing to be a fibroid is “morcellated,” or torn apart, the cancerous tissue can quickly spread to other areas of the body.
Hospitals Under the Microscope
Fitzpatrick also wants the agency to examine the procedures followed by three well-regarded hospitals – Brigham and Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center (URMC). He alleges the facilities failed to properly report deaths linked to procedures involving power morcellators.
One fatality occurred at the URMC’s Strong Memorial Hospital in 2012. A URMC spokesperson told Bloomberg News that while the FDA requires medical facilities to report serious injuries or deaths due to a device failure, malfunction, improper design or user error, the hospital did not report the death because it did not fit the facility’s interpretation of how a “device failure” is defined. According to the hospital, while the outcome was tragic, the power morcellator functioned as intended.