FDA Remains Undecided Regarding the Potential Ban on Power Morcellators
The Democrat & Chronicle reports that the Food and Drug Administration (FDA) held hearings more than two months ago regarding the issue of whether to ban power morcellators. However, the FDA has yet to rule on the issue and affected families are outraged about the delay.
FDA spokesperson Morgan Liscinsky provided, “The FDA is considering all available information, including the advisory committee’s input, in determining any future regulatory action.” She added, “If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register.”
Power 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. The problem is that some of the tissue being cut may contain undetected cancer. In April 2014, the FDA released a Safety Communication to medical specialists warning 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. Johnson & Johnson, the largest manufacturers of morcellators, has suspended sales of the surgical device after the FDA issued the Safety Communication.
Morcellators have been on the market for two decades, but little data exits about the device. According to a recent study published in the Journal of the American Medical Association (JAMA) and conducted by Columbia University doctors, 1 in 368 women who undergo a hysterectomy have an unsuspected uterine cancer that is at risk of being spread by the 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.
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