Members of Congress Call for Government AccountabilityAug 13, 2015
Twelve members of Congress have written to the Government Accountability Office (GAO) to ask the agency to investigate why a surgical tool used in gynecologic surgery was sold for two decades before the Food and Drug Administration (FDA) issued safety warnings about the device's risks.
The tool in question, the power morcellator, allows minimally invasive fibroid surgery and hysterectomy. Fibroid tumors and uterine tissue can be cut into tiny pieces that can be removed through tiny abdominal incisions. But the device can also spread and worsen undetected uterine cancer, Philly.com reports.
Uterine cancers that are difficult to detect prior to surgery can be spread in the woman's abdomen by the morcellator's rapidly spinning blades. Once the cancer is spread it can rapidly become more aggressive and this significantly reduces the woman's long-term chance of survival, according to the Wall Street Journal. This is what happened to Dr. Amy Reed, an anesthesiologist, whose cancer was spread through morcellation. Reed and her husband, Dr. Hooman Noorchashm, a heart surgeon, have been campaigning for a ban on the power morcellator. Philly.com reports that Reed has recently been treated for a recurrence of uterine leiomyosarcoma.
In response to the couple's campaign, the FDA conducted a review of the device and last year issued a warning about the morcellator's risk, using a new type of directive called "immediately in effect guidance." The agency did not hold a public comment period before issuing the warning. Since the warning, a number of hospitals have curtailed the use of the device, some health insurers 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.
Current FDA estimates are that up to one in 350 women undergoing hysterectomy might have an undetected cancer that could be spread by the morcellator. According to William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, 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 members of Congress asked, "How did they get it so wrong for so long?" The letter writers "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 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.
The letter's lead signer, Rep. Mike Fitzpatrick of Pennsylvania, has joined Reed and Noorchashm's push for broad changes in the medical-device approval process. Chuck Young, a GAO spokesman, said the agency would carefully consider whether to investigate, taking into account the availability of data, potential legal obstacles, and investigations that may be underway, Philly.com reports.