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...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 & ...
continue reading...The FDA’s Obstetrics and Gynecology Devices Panel has scheduled a hearing in July to discuss whether to ban power morcellators. According to the FDA, the agency has only banned a medical device once before.
Morcellation is sometimes used in minimally invasive laparoscopic hysterectomy operations to remove the uterus and/or fibroids that can cause pain, bleeding and ...
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A report published in the Pittsburgh Business Times indicates that the Johnson & Johnson subsidiary responsible for manufacturing power morcellators was warned eight years ago that their device could increase the risk of spreading cancer. The news is based on a series of communications between the company and a Pennsylvania pathologist, Dr. Robert Lamparter, who requested that Johnson & Johnson reconsider the ...
