FDA Warns Hysterectomy Morcellator Linked to Cancer Risk

April 17, 2014 — Experts are warning against the use of morcellators — an electric device used to cut up or “morcellate” the uterus — during hysterectomies due to the risk of spreading aggressive cancer. Lawsuits have already been filed by women who allege that they were never warned about the increased risk of cancer from morcellation.

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication describing the problem:

“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.”

Approximatley 1 in 350 women who get a hysterectomy to have fibroids removed also has uterine sarcoma, a type of cancer that can spread after undergoing morcellation.

According to the Wall Street Journal, about 55,000 to 75,000 hysterectomies a year involve morcellators. The commonly-used devices are a popular alternative to minimally-invasive “laparoscopic” surgery, especially for women who cannot undergo laparoscopy because they have a uterus filled with fibroids (benign growths that affect a high percentage of women). The solution is a morcellator, which is an electrical device that cuts up the uterus into small pieces and sucks those pieces out though a tube.

The problem is that there is no way to know if a fibroid is actually cancer until the tissue is removed. When a morcellator cuts up the uterus and the doctor does not use a protective surgical bag, small pieces of tissue can be left behind. If the tissue is cancerous, it can spread in the abdomen and significantly increase a person’s risk of death.

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