FDA discourages Use of Laparoscopic Power Morcellation for Hysterectomy, Uterine Fibroids Removal

DES Action USA communication:

DES Daughters, with their increased risk for uterine fibroids – pay attention! Find out what your doctor plans to do when surgically treating them. A tool called a power morcellator, that looks and works like the immersion blender found in your kitchen, may inadvertently spread cancer cells while breaking up the fibroid. You may want to be firm with your doctor about options. Sources: here.

Abstract:

Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.

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, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic 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. 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.

Sources:

• FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids, FDA, Press Announcements, ucm393689, April 17, 2014
• Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, FDA, Safety Communications, ucm393576, April 17, 2014
• Uterine Fibroids, NIH Fact Sheets, csid=50, March 29, 2013
• FDA Warns of Cancer Risk With Laparoscopic Device, MedPage Today, 45309, Apr 17, 2014