GAO asked to investigate FDA over morcellator device

Twelve members of Congress have asked the U.S. Government Accountability Office to investigate why an electric device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration.

The tissue-dissecting device, called a power morcellator, enables hysterectomies to be done through small rather than large abdominal incisions, but it can also spread and worsen an undetected uterine cancer.

After that horrible scenario befell anesthesiologist Amy Reed at a Boston hospital in late 2013, she and her husband, heart surgeon Hooman Noorchashm, launched a campaign to ban electric morcellators. The couple and their six children have since moved to the Philadelphia area, where she has recently been treated for a second recurrence of uterine leiomyosarcoma.

Their campaign prompted an FDA review that led hospitals and insurers to sharply curtail use of the device. The FDA concluded that up to one in 350 women undergoing hysterectomy with power morcellation might have a hidden cancer - not one in 10,000, the risk that gynecologists cited after the power morcellator first came on the market in 1993.

"How did they get it so wrong for so long?" asks the Aug. 7 letter to the GAO, which investigates how the government spends tax dollars. "We respectfully request that you investigate the root cause failure that ultimately led to the FDA's black box warning on ... morcellators in November 2014."

The lead signer is Rep. Mike Fitzpatrick (R., Pa.), who has joined Reed and Noorchashm in pushing for broad changes in the medical-device approval process. The other signers include high-ranking House members Louise Slaughter (D., N.Y.) and Rosa L. DeLauro (D., Conn.).

Noorchashm, who now works for Thomas Jefferson University Hospital, praised Fitzpatrick's leadership Friday.

GAO spokesman Chuck Young said the agency would decide whether to investigate after considering factors including the availability of data, potential legal obstacles, and investigations that may be underway.

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