Surgical Device Suspected Of Having Problems Under Probe. Last Friday, the U.S. Government Accountability Office (GAO) said it will investigate a surgical tool that was on the market for two decades before the Food and Drug Administration (FDA) warned it can spread uterine cancer.
Twelve members of Congress wrote to the GAO last month requesting an investigation into the laparoscopic power morcellator, a surgical tool used to cut up fibroid tumors so they can be removed through tiny incisions in minimally invasive surgery, the Wall Street Journal reports. Katherine Siggerud, managing director for congressional relations at the GAO, confirmed the investigation, which she said should begin in about five months. Siggerud could not say how long it would take to complete the probe.
The FDA estimates that 1 in 350 women who undergo morcellator procedures has an undetected cancer that a morcellator could spread and make worse. The morcellator’s rapidly spinning blades cut bulky growths or the uterus itself into pieces that can be removed through tiny incisions. But uterine sarcomas usually cannot be detected prior to surgery and the cancer can be spread in the woman’s abdomen, significantly reducing long-term chance of survival, according to the WSJ.
How FDA Handle Issues With Power Morcellators
The GAO investigation increases scrutiny into how the FDA handled issues with power morcellators that date back to 1991, when the first morcellator was cleared for sale in the U.S. Last year, the FDA said evidence indicated that the risk of hidden uterine sarcoma was much higher than many gynecologists believed. Records show the FDA long knew that morcellators could spread sarcoma cells in the patient’s abdomen, but the agency said the magnitude of the risk was not recognized until late 2013, according to the WSJ.
The members of Congress who wrote to the GAO, including Rep. Mike Fitzpatrick of Pennsylvania and Rep. Louise Slaughter of New York, asked the GAO to investigate the regulatory process the FDA used to clear morcellators for use in the U.S. The clearance process has been criticized as too lenient. The lawmakers also want to know whether hospitals and manufacturers complied with rules requiring the reporting of problems with the devices, how doctors were trained to use them, and what the FDA is doing to determine whether morcellators are safe to remain on the market.
The FDA has defended the regulatory process used to approve morcellators but said it is strengthening its surveillance of devices on the market. Johnson and Johnson, which had been the largest morcellator maker, voluntarily pulled its morcellators from the market last year, according to the WSJ.
In November 2014, the FDA amended an earlier morcellator advisory by calling for a black box warning for the device. The black box is the FDA’s strongest warning. Despite calls for a ban, the power morcellator remains on the market, although many hospitals have restricted its use to carefully screened patients and a number of health insurers will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.
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