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Hysterectomy Device May Spread Undetected Cancer, New Study Finds

The Wall Street Journal reports that a surgical device used to remove uterine fibroids and during hysterectomies may spread previously undetected cancerous tissue inside the body, according to a recent study published in the Journal of the American Medical Association (JAMA).

The study, conducted by Columbia University doctors, found that 1 in 368 women who undergo a hysterectomy have an unsuspected uterine cancer that is at risk of being spread by the surgical device, called a morcellator. The findings also showed the device may spread other types of cancers, such as endometrial cancer. Researchers studied the medical records of 36,000 women treated with the device at 500 U.S. hospitals over a period of 7 years. The importance of this study is that it consists of a much larger group of subjects than the Food and Drug Administration (FDA) initially studied when it approved the device.

Many doctors not involved in the study have expressed concern that the morcellator puts a certain population of women at an unreasonable risk. “This [study] just confirms it”, said Dr. David Mutch, chief of gynecologic oncology at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis.

In April 2014, the FDA released a Safety Communication to medical specialists that because there is no reliable method for predicting whether a women may have a uterine cancer, the laparoscopic morcellator should not be used during a hysterectomy or myomectomy (removal of uterine fibroids). The FDA emphasized that spreading the uterine sarcoma will significantly worsen the patient’s odds of long-term survival.

The JAMA study and data collected by the FDA propelled the agency to hold a two-day hearing earlier this month to assess the danger of the device. The FDA is expected to decide this year whether it restrictions should be placed on the use of morcellators or whether it should ban the tool altogether.

Morcellators use a blade to cut the uterine fibroids or the uterus into fragments so that the pieces can be removed through tiny laparoscopic incisions. Morcellators have been on the market for two decades, but little data exits about the device. Johnson & Johnson, the largest manufacturers of morcellators, has suspended sales of the surgical device after the FDA issued its Safety Communication warning in April. Some doctors suggest that the decision to suspend sales of the device does not go far enough; they are urging the company to recall its morcellators from the market.

 

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