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FDA Issues Warning on Procedure for Uterine Fibroids

The U.S. Food and Drug Administration warns that laparoscopic power morcellation can inadvertently spread cancerous tissue beyond a woman’s uterus and into other parts of her body.

This procedure, which is performed on tens of thousands of women every year, involves the use of a device to cut tissue into small sections that can be more easily extracted through tiny incisions during surgery. This allows for a much less invasive procedure than traditional abdominal surgeries. Morcellators are widely used in laparoscopic procedures to remove the entire uterus (hysterectomy) or to remove fibroid tumors (myomectomy) from the uterus.

Uterine fibroids, according to the National Institute of Health, are the most common benign tumors in women of childbearing age. Fibroids are made of muscle cells and other tissues that grow in and around the wall of the uterus or womb. The cause of fibroids is unknown. Risk factors include being African-American or being overweight.

In fact, the NIH reports that by age 50, 80 percent of African-American women have had fibroids. Although for some women, the fibroids are small enough that they never know they have them or they do not cause other complications. For others, surgery is necessary and the laparoscopic procedure had been around as a less invasive alternative with a much faster recovery than major surgery.

But the FDA estimates that about one in 350 women undergoing a hysterectomy or fibroid removal has an unsuspected type of cancer called uterine sarcoma.

Thus, this procedure may inadvertently spread the cancerous tissue to other parts of the body. The spreading of uterine sarcoma beyond the uterus can dramatically worsen a patient’s long-term prognosis.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement.

The diagnosis is usually made only after surgery, when the tissue is biopsied.

The FDA is not outright banning laparoscopic power morcellation, but it is urging patients and doctors to weigh the risks and consider alternative procedures. They are also advocating that women must be informed of these risks, something that has not been routinely done.

S.C. Rhyne is a blogger and novelist in New York City. Follow the author on Twitter @ReporterandGirl, and visit her website at

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