FDA Updates Warning on Use of Power Morcellation of Uterine Fibroids

A series of articles in the Wall Street Journal details investigation into the marketing, training and use of power morcellation for the removal of uterine fibroids and hysterectomies. The issue at hand is that if a fibroid turns out to be cancerous, the morcellation can cause rapid spread of cancer. Below one article tells the story of a New Hampshire woman who died from cancer when she was diagnosed with a uterine fibroid that was removed by morcellation at Dartmouth-Hitchcock health system. Her fibroid turned out to be cancer.

Excerpt from FDA Safety Communication

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 myomectomy. 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.

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

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