House Members Call on GAO to Investigate FDA over Morcellators

August 14, 2015

A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate the root cause failure that led to power morcellators remaining on the market for more than two decades before being slapped with a black box warning last year.

“Hundreds, if not thousands, of women in America are dead,” because of the power morcellator, which is used to remove uterine fibroids, the lawmakers say. They cite historical studies going as far back as 1990 showing the increased risk of spreading cancer in women.

“Despite these studies, as late as last year, the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only 1-in-10,000,” the letter states. “How did they get it so wrong for so long?”

Morcellators came under scrutiny after the FDA issued a safety alert last year saying the instrument’s blades could spread unsuspected cancers in as many as one in 352 cases.

As part of the probe into morcellator safety, the group is asking the GAO to consider several questions:

  • Did the FDA’s reliance on 510(k) clearance sufficiently identify morcellators’ risks?
  • Were medical device reporting regulations followed appropriately by manufacturers, importers, user facilities and the FDA?
  • What activities or training did manufacturers provide clinicians, and what professional society standards were applied for training on the use of these devices?
  • What additional steps are being taken, beyond the black box warning, to determine whether the devices are safe to remain on the market?

The Aug. 7 letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr., (D-N.J.), Lou Barletta, (R-Pa.), Doug LaMalfa, (R-Calif.), Anna Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.) and Rick Larsen (D-Wash.).

During markup of the 21st Century Cares Act, which passed the House last month, Fitzpatrick offered seven amendments focused on getting unsafe devices off the market, particularly power morcellators. None of the amendments made the final bill (IDDM, July 10).

To read the letter, visit www.fdanews.com/081715-morcellator-letter.pdf. – Elizabeth Hollis