F.D.A. Warns About Morcellator Hysterectomy Procedure
According to the FDA, doctors should stop using a procedure performed on thousands of American women a year in the course of hysterectomy uterine surgery, because it increases the risk of spreading cancerous tissue.
The procedure, power morcellation, cuts uterine tissue into pieces that can be pulled out through the incisions made during laparoscopic surgery.
The morcellator devices, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.Morcellator Devices: No Clinical Trials
Morcellators were allowed onto the market in the 1990s without the usual clinical trials in patients because they were similar to other devices that had already been approved.
This is the controversial 510(k) fast track process that medical device experts say lead to current safety debacle with the metal on metal hip implants and other medical devices.FDA Concerns
The F.D.A. became concerned about morcellators because of recent news reports about patients harmed by them. A cancer case in Boston, first reported in December, focused national attention on the sarcoma cancer risk.
Dr. Reed, a patient, had a hysterectomy because of fibroids in October 2013. A biopsy after the surgery found a hidden sarcoma, an extremely aggressive type of cancer. Morcellation had spread the tumor around inside her pelvis and abdomen, causing advanced Stage 4 cancer.Hysterectomies is Big Business
According to the FDA, about a half-million women a year have hysterectomies to remove the uterus, and some 50,000 of those operations involve power morcellation of tissue containing fibroid tumors.
Fibroids are benign, but can sometimes hide cancers. If an unsuspected cancer is present, as in Dr. Reed’s case, the rapidly spinning blades of a morcellator can spray cancer cells around and speed the progression of the cancer.Sarcoma Cancer Spread by Morcellators
Sarcomas are extremely aggressive and almost never detectable before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the woman’s chances of long-term survival are reduced.Sarcoma Cancer Risks
According to the FDA, one in 350 women who have a hysterectomy or fibroid removal have unsuspected sarcomas. That figure, is considerably higher than estimates that gynecologists had been using, which ranged from one in 500 to one in 10,000.
FDA had the authority to ban morcellators, but did not. The FDA said that doctors and patients could weigh the risks on a case-by-case basis.
The FDA emphasized that women must be informed of the risks, something that has not been routinely done, in part because the threat was thought to be low. Many women having hysterectomies were not even told that morcellation was being performed.