FDA Examines For Cancer Risk Of Fibroid Removal Devices
There is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body, according to FDA health advisers.
FDA further added that women who do undergo the procedure should sign a written consent form stating they understand the serious risks of laparoscopic power morcellation, in which electronic tools are used to grind tissue and remove it through a small incision in the abdomen.
Surgeons developed this technique as an alternative to traditional surgery that required a larger incision, resulting in more bleeding and longer hospital stays. However, FDA in a meeting concluded that the risk of accidentally spreading undetected cancer to other organs may be far more common than previously thought.
"There's no evidence that the bags or any containment devices prevent the outcome we are trying to prevent," said Dr. Craig Shriver of the Walter Reed Medical Center, in the press release.
"It doesn't sound like anyone has confidence that those will be able to predict the vast majority of leiomyosarcomas," said Dr. Michael Diamond, of Georgia Regents University.
According to agency estimations, as many as 1 in 350 women may have undetected uterine cancer that can be ruptured by the technique. Previously the rate was estimated to around 1 in 7,000.