FDA Warns Against Procedure Used in Removing Fibroids

Image: JAMA, ©AMA

Image: JAMA, ©AMA

The US Food and Drug Administration (FDA) is discouraging the use of a surgical technique often used during minimally invasive surgery to treat uterine fibroids because it poses a risk of inadvertently spreading cancer cells from an undetected uterine tumor.

The focus of the agency’s concern is the use of medical devices called electric or power morcellators during laparoscopic (minimally invasive) surgery to remove the uterus or fibroids, noncancerous growths that develop from the muscular tissue of the uterus. The morcellator is used to cut uterine tissue into fragments that can be removed through the small incisions used in laparoscopic surgery. But in a safety communication released today, the FDA said that, based on its analysis of currently available data, 1 in 350 women who are treated for fibroids with surgery—a hysterectomy or myomectomy (fibroid removal)—is found to have an unsuspected uterine sarcoma, such as a leiomyosarcoma.

“If power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA said. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

As a JAMA news feature published earlier this year noted, in recent months, some critics of the procedure have said that use of the technique may be too risky, whereas others said that more research on risks was needed before banning it outright. The Society of Gynecologic Oncology issued a statement in December about the potential risks and the concern that no reliable methods exist to distinguish benign growths from cancers before they are removed. Some prominent US medical centers, including Brigham and Women’s Hospital, Massachusetts General Hospital, and the Cleveland Clinic issued statements stressing the importance of counseling patients about the procedure and potential risks.

An estimated 600 000 hysterectomies are performed annually in the United States. According to the National Institutes of Health, more than 200 000 hysterectomies are performed each year for uterine fibroids.

Various therapies, including drugs, surgical removal of individual fibroids, and hysterectomy, are used to treat symptoms caused by fibroids, which may include heavy or prolonged menstrual bleeding or pelvic pressure or pain. “Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids,” the FDA said.

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For more information:

Critics of Fibroid Removal Procedure Question Risks It May Pose for Women With Undetected Uterine Cancer. Hampton, T. JAMA. 2014;311(9):891-893.

Evaluating the Risks of Electric Uterine Morcellation. Kho, KA and Nezhat, CH. JAMA. 2014;311(9):905-906.

 

 

 

 

 

 

 

 

 

 

 



Categories: Gynecology, Oncology, Surgery, Women's Health

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