WASHINGTON – The Food and Drug Administration is warning women that a surgical procedure used to eliminate growths in the uterus could inadvertently spread cancer to other parts of the body.
The agency is discouraging doctors from performing the procedure, which uses an electronic device to grind and shred uterine tissue so it can be removed through a small incision in the abdomen. Known as laparoscopic power morcellation, the technique is widely used to treat painful fibroids, either by removing the noncancerous growths themselves or the entire uterus.
Doctors have long recognized the risk of accidentally spreading cancer from undetected tumors, but FDA officials said Thursday the problem now appears far more common than previously thought. An FDA analysis estimates that 1 in 350 U.S. women who undergo fibroid procedures each year have a form of cancer called uterine sarcoma.
“There is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly reducing the patient’s likelihood of long-term survival,” said Dr. William Maisel, the FDA’s director for medical devices. He added that there is no reliable way to spot cancerous uterine tumors before removing them.
Electronic uterine procedures were developed as a less invasive alternative to traditional surgery, in which the uterus or fibroids are removed through the vagina or a large incision in the abdomen. Studies suggest the device-assisted approach results in faster recovery and smaller scars.
Fibroids can grow to the size of cantaloupes, causing severe pain, heavy bleeding, and bladder and bowel dysfunction, mostly among women in their late 30s and 40s. It’s unclear what causes the tumor-like growths.
The FDA approved the first electronic morcellators in 1995 and about two dozen are now available in the U.S.
Despite the risks outlined in a press teleconference, agency officials said the devices will remain on the market because there still may be patients who benefit from the procedure.
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