FDA warns against common uterine procedure

MINNEAPOLIS — The Food and Drug Administration is warning doctors against using a popular method to remove the uterus or uterine fibroids without open surgery because it can spread cancer cells.

The technique, called laparoscopic power morcellation, involves shaving down the tissue or growths into pieces that can be removed through the tiny holes used to insert the equipment. The agency found that 1 in 350 women who get a hysterectomy or have their fibroids removed have a type of cancer that can spread beyond the uterus with the approach.

Distribution of cancerous cells in the abdomen and pelvis can significantly worsen the woman’s chances of long-term survival, the agency said in a safety communication. Companies that make equipment for the procedure, including Johnson & Johnson, were urged to ensure they give accurate information about the risks on their product materials, the FDA said.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.”

It’s not known how many women undergo such procedures each year in the U. S., though more than 20,000 minimally invasive or robotic hysterectomies are done annually, according to an article in the Journal of the American Medical Association.