FDA Discourages Use of Morcellation

Morcellation – a procedure that involves the shredding and removal of tissue – is a common surgical technique used during hysterectomy or the treatment of uterine fibroids. Recently, the procedure has come under scrutiny for posing risks of spreading cancer. On Thursday, April 17, 2014 the U.S. Food and Drug Administration (FDA) issued an official press announcement discouraging the use of power morcellation for removal of the uterus or uterine fibroids.

Uterine fibroids are non-cancerous growths that form on the uterine wall and most women will develop them at some point during their lives. In cases where symptoms are severe, surgical intervention may be necessary. Morcellation is one surgical approach performed using a small medical device that divides uterine tissue into small fragments that can be easily removed through a small incision in the abdomen.

The FDA's safety communication notice warns against morcellation based on an analysis of data suggesting that it poses a risk of spreading undetected cancerous tissue in areas outside of the uterus. According to the FDA, roughly 1 in 350 women who undergo treatment for fibroids have an undetected type of cancer known as uterine sarcoma. When laparoscopic morcellation is used to treat these women, there is a risk of the cancerous tissue spreading and "significantly worsening the patient's likelihood of long-term survival." In a previous blog, we discussed reported cases of cancer spreading after morcellation.

The announcement also noted that a warning has been issued because there is no way to determine if a uterine fibroid is cancerous prior to removal, and because patient well-being must always be a top priority. The FDA will continue to work with medical experts and the Obstetrics and Gynecological Medical Devices Panel to discuss the future of power morcellation and whether boxed warnings should be added to device labeling.

What You Can Do

If you or someone you know is currently seeking treatment for uterine fibroids or considering hysterectomy, be aware that the FDA is now discouraging the use of laparoscopic power morcellation. You can also take steps toward speaking with your doctor or seeking a second opinion to learn more about alternatives to morcellation and your available treatment options.

As a leading expert on laparoscopic surgery, hysterectomy, and pelvic pain conditions, Dr. Seckin can serve as a resource to women who would like to learn more about their options. If you live in New York or the Tri-State area or if you are willing to travel to New York, call 888-885-8311 or make an appointment online.