How Did the FDA Blow it on Power Morcellators?
Members of Congress, as well as the U.S. Government Accountability Office (GAO), want to know how the U.S. Food and Drug Administration (FDA) could have erred so badly in its oversight of the power morcellator device. They want to know why the device was marketed for approximately 20 years before the FDA finally warned that it could cause uterine cancer to spread throughout a woman’s abdomen.
Power Morcellators and Uterine Cancer
Power morcellators can be used during a hysterectomy to remove a uterus that contains fibroids or a myomectomy, which is a procedure to remove only the fibroids. Fibroids are benign growths that can occur on the uterus and surrounding areas. Unfortunately, tumors associated with a rare form of cancer known as uterine sarcoma can often mimic a fibroid. When these hidden tumors are torn apart by the morcellator, cancerous tissue is often left behind in the body, causing the cancer to spread to other areas of the body.
Members of Congress asked the GAO to investigate how the FDA could possibly have missed the dangers associated with power morcellators for so long. On March 18, a terse FDA statement said only that the agency has been notified of the GAO investigation and will fully cooperate.
There is evidence that the FDA was aware of the risk of power morcellators for several years prior to late 2013, when they claim they were made aware of the dangers associated with these devices. Johnson & Johnson, the largest manufacturer of the device, told the Wall Street Journal in 2015 that its instructions have long cautioned about the potential spread of malignant tissue.
A letter from 12 members of Congress to the GAO in August 2015 stated that the FDA warning came decades after studies indicated a serious problem with power morcellators. In fact, the letter pointed to a study conducted as far back as 1990 stating that as many as 1 in 200 women had a hidden uterine sarcoma. However, the FDA maintained that the risk of the problem was 1 in 10,000.
As the letter stated, “How did they get it wrong for so long?”