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FDA tightens guidelines on technique for uterine fibroid surgery

By Toni Clarke

WASHINGTON, Nov 24 (Reuters) - The U.S. Food and Drug Administration has tightened its guidelines on the use of a uterine surgical technique, saying it has been linked to the spread of a rare type of cancer.

The agency said on Monday it is recommending that a boxed warning be placed on laparoscopic power morcellator devices used to treat uterine fibroids. Such an FDA warning is the strongest that a medication or treatment can carry while still remaining on the U.S. market.

The devices are used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening. The procedure is designed to shorten recovery time and reduce wound-site infections.

Yet the technique can cause injury to local tissues and organs and spread unsuspected malignant tissue to places outside the uterus. In April, the FDA issued an alert discouraging use of the devices to remove fibroids due to these concerns.

The FDA estimates that 1 in 350 women who have fibroid surgery have an unsuspected uterine cancer.

Fibroids are often benign and may cause pelvic pain and bleeding. Sometimes a hysterectomy is required to remove them.

Johnson & Johnson's Ethicon unit, the biggest maker of morcellator devices, suspended sales of the device following the FDA's advisory.

A spokesman for the company was not immediately available to comment on the FDA's latest announcement.

The agency said the devices should not be used to remove tissue containing fibroids in patients who are peri-or post-menopausal, or whose fibroids could be removed intact through the vagina or small incision. This group accounts for most women with fibroids who undergo surgery.

The devices should also not be used in procedures in which the tissue is known or suspected to be cancerous, the agency said.

"The two contraindications help to clarify the narrow population of patients in which laparoscopic power morcellation may be an appropriate therapeutic option," the FDA said in a statement.

"For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure."

The recommendation follows a July meeting of an FDA advisory panel, which suggested a boxed warning - in which the risks are highlighted in a black box - would be useful.

(Editing by Bernadette Baum)