J&J Pulls Hysterectomy Tool Tied to Cancer Risk
Controversial device had been used for minimally invasive hysterectomies, uterine fibroid removal
Concerns about an increased cancer risk with morcellators have been percolating since the FDA first issued its warning in April.
Earlier this month, an FDA advisory panel said there is no way to guarantee there is no risk of spreading undetected cancer to another part of a woman's body, and they recommended that women who undergo procedures that use the morcellator should sign a written consent stating they understand the potential risks. The agency isn't obliged to follow the advice or recommendations of its advisory committees, but usually does so.
The FDA has estimated that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma. About 60,000 such surgical procedures are performed every year, according to Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.
A study published just last week in the Journal of the American Medical Association more clearly pinpointed the risk of spreading cancer if morcellation was used to remove the uterus in a laparoscopic hysterectomy. The researchers noted that the risk was higher for older women.
Women who already have undergone power morcellation don't need to get a cancer screening, because some of the tissue removed during the procedure would have been sent for pathologic analysis, Maisel said. If cancer had been detected, they would have been informed, he added.
"We think that most women who have undergone these procedures require routine care," he said. "If they don't have any ongoing or recurrent symptoms, they should be fine."
Women who need a hysterectomy or fibroid removal can still undergo traditional or laparoscopic surgery, just without the use of a power morcellator, Maisel said.
The FDA approved the first power morcellator for use in 1995, Maisel said.
The medical community has been aware of the risk of cancer spread during power morcellation since the devices came onto the market, Maisel said, but "the magnitude of the risk appears to be higher than what was appreciated in the clinical community."