Long use of cancer-spewing surgical device exposes weakness in FDA oversight

Enlarge (credit: Getty | Congressional Quarterly)

A government report released this week on a cancer-spreading surgical device highlights a weakness in the Food and Drug Administration’s ability to spot harms from drugs and devices on the market.

The surgical device, called a power morcellator, has been on the market since 1991 and is FDA-approved for use in minimally invasive gynecological surgeries, including removing benign uterine tumors (fibroids). The device shreds tissue into small pieces so it can be removed from the body through small incisions. But in the event that a patient has an undiagnosed cancer, the device can fling cancer cells throughout the body, where they can seed new tumors. The first time the FDA got a report of this happening was in 2013—and it was from a patient, not a doctor or hospital using the device. By that time, at least 50,000 US women were having surgery with the device a year, The New York Times reports.

The patient, Dr. Amy Reed, then 40, underwent a hysterectomy due to fibroids, unaware that she had a hidden, aggressive type of cancer. The surgery spread the tumor cells, which became advanced Stage 4 cancer. According to the Times, she has been fighting it ever since, undergoing surgeries for cancer in her abdomen, spine, and lungs, as well as undergoing chemotherapy, radiation, and other treatments.