FDA Has Yet to Decide on Power Morcellators

FDA_Yet_to_Decide_on_Power_MorcellatorsThe safety of power morcellators is highly questioned following reports that the tools can spread hidden cancers in women undergoing procedure to remove uterine fibroids. In April, the U.S. Food and Drug Administration (FDA) warned against using power morcellators because of this risk, and held a meeting two months ago to discuss banning the device. Currently, however, the FDA has not yet decided the fate of the tools, Democrat & Chronicle reports.

“I cannot speculate regarding FDA action on this issue,” wrote FDA spokeswoman Morgan Licinsky wrote in response to whether the FDA was going to make a decision. “The FDA is considering all available information, including the advisory committee’s input, in determining any future regulatory action,” she stated. “If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register.”

In a minimally invasive hysterectomy or myomectomy, power morcellators cut up tissue into smaller pieces so they are easier to remove through small incisions. The issue is that some women have sarcomas, a cancer that is difficult to detect prior to surgery. In these situations, morcellation can spread or “seed” the cancer. According to an FDA analysis, 1 in 350 women undergoing hysterectomy or fibroid removal have sarcomas.

According to Democrat & Chronicle, affected families are outraged at the FDA’s silence. Dr. Hooman Noorchashm, who spoke out against the devices when his wife developed  stage 4 cancer following a minimally invasive gynecological surgery, called for the resignation of Dr. William Maisel, chief scientist at the FDA Center for Devices and Radiological Health. Noorchashm accused Maisel of putting industry needs ahead of patient safety in an email shared with media nationwide. Some believe the FDA is delaying a decision for the use of morcellation within a bag. In theory, this would be safer than current morcellation procedures but it is uncertain how this would be tested ethically.

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