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Morcellator Uterine Cancer -- When a Hysterectomy Turns Deadly

Under normal circumstances, a hysterectomy – the surgical removal of a woman's uterus – is a fairly routine procedure. Though it is major surgery that entails a certain amount of risk and requires a convalescent period of up to five days, complications are relatively rare.

When Donna Burkhart of Philadelphia, Pennsylvania, underwent her hysterectomy, she was told that having the procedure done laproscopically rather than through the abdomen would be easier, less painful and reduce her convalescence time to as little as two days. Two years later, she was dead of metastatic leiomyosarcoma, a rare, but aggressive form of cancer that attacks smooth (involuntary) muscle tissue. Prior to her surgery, there was no indication that she was at risk for cancer of any kind.

Recently, her husband filed the first lawsuit over the surgical instrument used in his late wife's surgery – known as a morcellator. This device literally minces up tissue (in this case, the uterus) in order to facilitate its removal without invasive surgery. Laproscopic power morcellators, originally designed for removal of the uterus, have been in use since 1993, and use of this instrument has become fairly widespread for a variety of surgeries, including the removal of uterine fibroids (leiomyomas), a type of benign growth that can nonetheless cause pain and discomfort and even interfere with reproductive function.

What is now becoming apparent is that procedures using power morcellators can spread materials in which cancerous or pre-cancerous cells may be hiding throughout the abdomen. Even if fibroids are benign, it can cause complications and make management of the condition far more difficult.

This week, the U.S. Food and Drug Administration updated a warning, originally published in April 2014, against the use of laproscopic power morcellators. The FDA previously estimated that as many as 1 in 350 women undergoing surgery for hysterectomy or the uterine fibroids (myomectomy) have undetected cancer cells. Laproscopic power morcellation greatly increases the risk of these cancer cells spreading, also known as upstaging. While stopping short of banning use of the device altogether, the FDA has issued an “Immediately In Effect”(IIE) advisory warning against the use of power morcellators in the vast majority of female patients. In addition, the FDA has recommended that manufacturers immediately include a statement about risks and safety concerns in a “black box” warning on the product labeling. (One manufacturer, Ethicon, has already withdrawn its product from the market.)

Specifically, the FDA recommends that power morcellators not be used on older women who are either going through menopause or are post-menopausal, as these patients appear to be at highest risk for undetected cancerous or pre-cancerous fibroids. The FDA has also contraindicated the use of morcellators in women that are candidates for en bloc tissue removal. The FDA has also urged patients to have a thorough discussion with their physicians, and learn about all the surgical options available to them.

For more information regarding the morcellator caused uterine cancer, click Morcellator Cancer Lawsuit.

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