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FDA Warning for Hysterectomy Morcellator Cancer Risk

FDA Warning for Hysterectomy Morcellator Cancer Risk

April 17, 2014 — In a Safety Communication, the U.S. Food and Drug Administration (FDA) is warning against the use of morcellators, a popular surgical device that is used to cut up the uterus during a hysterectomy, because it can leave tiny pieces of cancerous tissue that spread in the abdomen.

Every year, approximately 55,000 to 75,000 women undergo a hysterectomy with a morcellator, according to the Wall Street Journal.

The devices are mostly used in women who have a hysterectomy because their uterus is filled with fibroids, which are benign tissue growths. A fibroid-filled uterus is too cumbersome to be removed with traditional laparoscopic techniques, so a morcellator is used to cut up the uterus into tiny pieces, which are then sucked out in a tube.

There are two big problems with this: morcellators tend to leave behind tiny pieces of tissue, and there is no way to tell if a fibroid is actually cancer until after the procedure.

If a morcellator is used on a woman with cancer, the malignant cells can potentially spread and grow throughout the abdomen. Approximately 1 in 350 women who have a hysterectomy to remove fibroids also has a type of cancer (uterine sarcoma) that can spread after morcellation.

Lawsuits have already been filed by women who allege that doctors did not warn them about this risk, despite studies dating back to 2011. The risk can be minimized by placing the uterus in a surgical bag before morcellation, but the bag is difficult to use and unpopular. In the last few days, several hospitals have mandated the use of bags and provided stronger warnings for patients.

Do I have a Morcellator Lawsuit?

The Schmidt Firm, PLLC is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know has been injured by cancer after a hysterectomy using a morcellator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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