Government Accountability Office Considering Request to Investigate Controversial Surgical Tool

The Government Accountability Office (GAO) is considering a request from 12 members of Congress that it investigate the Food and Drug Administration’s handling of the power morcellator, a surgical tool used in gynecologic surgery for two decades before the FDA issued safety warnings about the device’s risks.

The power morcellator, allows minimally invasive fibroid surgery and hysterectomy. The device cuts fibroid tumors and uterine tissue into tiny pieces that can be removed through small abdominal incisions. But the device can also spread and worsen undetected uterine cancer, Philly.com reports.

Dangerous uterine cancers can masquerade as benign fibroids prior to surgery and the cancerous tissue can be spread in the woman’s abdomen by the morcellator’s rapidly spinning blades. Once spread, the cancer becomes more aggressive, significantly reducing the woman’s long-term survival chances, according to the Wall Street Journal.

Dr. Amy Reed, an anesthesiologist, experienced the spread of uterine cancer through morcellation. Reed and her husband, Dr. Hooman Noorchashm, a heart surgeon, have since campaigned for a ban on the power morcellator. According to Philly.com, Reed has recently been treated for a recurrence of uterine leiomyosarcoma.

Last year the FDA issued a warning about the cancer risk through a new type of directive, “immediately in effect guidance,” bypassing the usual steps of draft guidance and public comment. Last November, the FDA ordered a black box warning, its most serious warning, for the device. In response to the warning, many hospitals curtailed the use of the device and health insurers, including Aetna, will no longer cover routine use of morcellators. Manufacturers, including Johnson & Johnson’s Ethicon division, have taken the device off the market. The FDA advised that morcellator use should be avoided for women at or near menopause or in patients whose tissue can be removed intact through the vagina or via a small abdominal incision. Morcellators should never be used when the tissue is known or suspected to be cancerous.

As many as one in 350 women undergoing hysterectomy might have an undetected cancer that could be spread by the morcellator, according to the FDA’s most current figures. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said there is “no reliable way” to determine if a uterine fibroid is cancerous prior to removal. When the power morcellator came on the market in 1993, the risk was estimated to be one in 10,000, Philly.com reports. In the August 7 letter to the GAO, the letter writers asked, “How did they get it so wrong for so long?” The letter writers “respectfully’ requested that the GAO “investigate the root cause failure that ultimately led to the FDA’s black box warning on . . . morcellators in November 2014.” But the FDA said the magnitude of the risk was not clear until the issue came into the spotlight in late 2013, according to the Wall Street Journal.

GAO spokesman Chuck Young said the agency will decide whether to investigate, after evaluating such factors as the availability of data, potential legal obstacles, and investigations that may be underway, Philly.com reports.

 

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