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Physicians Warned of Risks in Fibroid Removal Procedure: Morcellation

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According to the FDA about half a million women undergo hysterectomies every year; about 50,000 of those operations involving ‘power morcellation’ of tissue containing fibroid tumors. “The procedure involves using a device to cut tissue into pieces that can be pulled out through the tiny incisions made during minimally invasive surgery. The devices, known as morcellators, have been widely used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the entire uterus.” (NYT, 4/17/14)

The morcellator features tiny blades that slice through the tumors, spreading bits of tissue and any undetected cancer cells through the body. Fibroid tumors are benign but they can hide small sarcomas, which are aggressive, hard to detect cancers. A sarcoma is usually diagnosed after a tissue biopsy—at which point the damage has been done if a morcellator was used to cut into the tissue in order to remove a sample.

The use of morcellators gained popularity because it allows for hysterectomies and surgical removal of tumors without having to perform an open surgery. Laparoscopic surgeries are considered less dangerous and have a faster recovery. Most women were not made aware of the details of how the surgery was performed or the risks involved. It was only after hearing stories of patients who were diagnosed with cancer – after such surgeries – that the FDA began to study the procedure and issue the recent advisory.

The FDA is urging doctors to stop performing the procedure in uterine surgeries. It has suggested guidelines for doctors on informing patients of the surgery and the risks involved.

According to Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, one in 350 women who have a hysterectomy or fibroid removal have unsuspected sarcomas. This revised figure (based on review of medical literature) is significantly higher than the previous estimate gynecologists used, predicting the risk of sarcomas to be from one in 500 up to one in 10,000. (NVO News, 4/18/14)  Dr. Maisel stated, “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. In general, the procedure should not be performed.”

One doctor quoted in the New York Times article notes that doctors are taught that cutting into cancerous tissue is not advised. Any suspected tumor or mass should be removed intact to minimize chances of spreading the cancer.  (NYT, 4/17/14)

Any woman planning on a hysterectomy or removal of uterine fibroid tumors should talk to her gynecologist about this procedure.  The full FDA report is here.

 

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