FDA Discourages Uterine Procedure for Cancer Threat

May 12, 2014 5:12 pm ET

(Corrects last paragraph in story published April 17 to show doctor’s wife wasn’t treated with the da Vinci robot.)

April 17 (Bloomberg) -- The U.S. 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.”

The FDA’s Obstetrics and Gynecological Medical Devices Panel will meet to discuss the risks and other information on to the procedure, the agency said.

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 published in the Journal of the American Medical Association in March.

Traditional Surgery

The tissue taken during surgery is typically tested for cancer, so women who have already undergone the procedure and told their results were normal should get routine care. The method is discouraged for anyone who will undergo a hysterectomy or fibroid removal. Traditional surgery or minimally-invasive approaches that don’t require tissue to be shaved are available, the agency said.

Along with Johnson & Johnson’s Ethicon unit, the equipment for the process is manufactured by closely-held companies including Karl Storz GmbH & Co., Richard Wolf Medical Instruments Corp., LiNA Medical and Blue Endo.

While Intuitive Surgical Inc.’s da Vinci robot doesn’t use morcellation, it deserves mention since it is being used more often and the uterus must be broken into smaller pieces to be removed from the abdomen during the procedure, according to Hooman Noorchashm, a Boston-based cardiothoracic surgeon.

Noorchashm filed a petition on Change.org to stop use of morcellation after it was performed on his wife, also a Boston- based doctor. She was subsequently diagnosed with cancer.