Laparoscopic power morcellation not right for removal of uterus or uterine fibroids

The U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.

In the interim, the agency has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and health care professionals.

Source: U.S. Food and Drug Administration, USA



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