morcellation: FDA warning

How power morcellators inadvertently spread uterine cancer

imagesUntil a few weeks ago, I’d never even heard of a “power morcellator.” Nor was I aware of the controversy that has pitted defenders of a woman’s right to choose a minimally invasive laparoscopic procedure in removing fibroids—enabled by the power morcellator–and those who decry the danger it poses in spreading an undetected uterine cancer throughout a woman’s abdomen. The most outspoken member of the anti-morcellation group is surgeon Hooman Noorchashm. His wife, Dr. Amy Reed, had a laparoscopic hysterectomy that resulted in morcellating a hidden cancer, progressing it to Stage IV sarcoma. Below is their video (link is here), followed by a recent FDA warning. I may write this in stages or parts. (I will withhold my view for now, I’d like to know what you think.)

Morcellation: (The full Article is here.)

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FDA Safety Communication:images-1

UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

The following information updates our April 17, 2014 communication.

Date Issued: Nov. 24, 2014

Product: 
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Purpose: 
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.

Summary of Problem and Scope: 
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.

Based on an FDA analysis of currently available data, we estimate that approximately 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. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.

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 long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. Continue reading

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