Gynecologists Continue Using Power Morcellators Despite FDA Warning, The Wall Street Journal Reports
The Wall Street Journal reports that doctors nationwide are continuing to use a popular surgical tool, known as power morcellators, even after the United States Food and Drug Administration (FDA) warned that the device can spread undetected cancer. The Wall Street Journal notes that this demonstrates “the limits of the regulator’s reach into clinical practice.”
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.
A recent study, published in the Journal of the American Medical Association (JAMA) and 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.
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.
A power morcellator is a surgical device used to remove fibroid tumors and during hysterectomies. The devices uses a blade to cut the uterine fibroids or the uterus into fragments so that the pieces can be removed through tiny laparoscopic incisions. Power 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. However, other doctors continue to use these surgical devices in their normal practice, as reported by The Wall Street Journal.
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