According to Nasdaq, the American health insurance company Aetna, Inc., will no longer cover routine procedures involving laparoscopic power morcellators. Aetna provides the nation’s third largest health care plan, with roughly 23 million members, and its decision not to cover routine morcellator operations will likely have a large impact on manufacturers of the device.
Power morcellators are a medical instrument used in minimally invasive, or ...
continue reading...The FDA released a statement discouraging the use of power morcellators in gynecological procedures because of significant cancer risks. A story by CBS Pittsburgh reports of a new study by Columbia University that further confirmed that power morcellators can spread undiagnosed stage 1 cancer.
The Columbia University study concluded that an estimated 1 in 368 women have uterine cancer at the time they undergo a gynecologic procedure. As a result, doctors may be ...
continue reading...A panel of Food and Drug Administration experts says that it is unlikely that power morcellation can be used to remove fibroids from women without the risk of spreading undetected cancers to other parts of the body. The FDA takes into consideration the opinions of its health advisors on these panels when making regulatory decisions about medical devices.
Power morcellators are used in the removal of fibroids and in some hysterectomies. Fibroids can cause ...
continue reading...After much speculation about the risk of spreading cancer with power morcellators, a study published in the Journal of the American Medical Association has assembled information on this risk. The risk was quantified from a review of data from over 200,000 patients.
The medical records review showed that 36,470 women had procedures where the uterus was fragmented using morcellation. Of those, one in every 368 women had an undiagnosed uterine cancer, resulting in 99 patients, or about ...
continue reading...Power morcellation was, until recently, considered a reasonable option for women seeking treatment for uterine fibroids. Amidst FDA warnings and various recalls, this option has been largely advised against. An article in the Wall Street Journal discusses the alternatives to power morcellation that are available to women that want to avoid this risky procedure.
Laparoscopic power morcellators are currently being investigated regarding their potential risk in spreading cancerous tumors in women. ...
continue reading...Two U.S. senators, Charles Schumer and Kirsten Gillibrand have stepped forward to request further FDA action to regulate the use of power morcellators. An article in Modern Healthcare documents the growing debate over whether to end completely or restrict the use of laparoscopic power morcellators.
The plea from the senators is for the FDA to pull all morcellator devices from the market at least until further studies are conducted. The letter cites a study at Brigham & ...
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