gao to investigate fda actions around power morcellators

The U.S. Food and Drug Administration (FDA) made headlines last November when it strongly urged surgeons not to use power morcellators in either hysterectomies or myomectomies, and decreed black-box warnings, the highest warning level issued by the agency, would henceforth be used on the devices.  

These rather definitive actions by the FDA came on the heels of its announcement in April 2014 that power morcellators, drill-like devices that cut uterine tissue into smaller segments to be removed laparoscopically, could pose a danger to the roughly one in 350 women who have undetected cancer . Specifically, power morcellation could actually spread the malignancy throughout the abdominal cavity. 

As definitive as these actions may seem, 12 members of Congress actually penned a letter to the Government Accountability Office (GAO) just last month asking it to undertake a two-pronged investigation designed to find answers to the following questions:

  • Why did it take the FDA so long to take this action against power morcellators given they have been on the market since 1991 and long linked to an elevated uterine cancer risk?
  • Did the FDA’s expedited approval process, known as 510(k), somehow miss this elevated cancer risk?

For those unfamiliar with 510(k), it essentially allows a medical device manufacturer to get its product approved without either premarket safety testing or postmarket monitoring, provided it can show be shown the device is substantially similar to several already on the market.     

In recent developments, the GAO has indicated it will launch the requested investigation in roughly five months. It will certainly be fascinating to see what the investigation into power morcellators, which are being abandoned by physicians, manufacturers and insurers in great numbers, will determine.

Stay tuned for updates.

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