FDA Still Undecided About Ban on Power Morcellator

Cancer-Risk-Associated-with-Surgical-ToolIn July, the Food and Drug Administration (FDA) held hearings on whether to ban the power morcellator, a surgical tool that opponents say can spread cancer during minimally invasive hysterectomies and uterine fibroid removal.

The morcellator uses high-speed blades to mince uterine tissue so that it can be removed through small incisions during minimally invasive surgery. Critics of the device say that if the tissue being sliced up contains undetected cancer, the morcellator can spread malignant cells in the patient’s abdomen, the Rochester, NY Democrat & Chronicle reports. An FDA spokesperson said the agency “is considering all available information, including the advisory committee’s input, in determining any future regulatory action,” but did not say when the agency would announce its decision.

Dr. Hooman Noorchashm is among those calling for the power morcellator to be banned. His wife had a gynecological procedure with a power morcellator and was later diagnosed with stage 4 cancer. Noorchashm accuses the FDA of putting industry interests ahead of patient safety, and he calls for the resignation of Dr. William Maisel, the deputy director and chief scientist at the FDA Center for Devices and Radiological Health, according to the Democrat & Chronicle.

Johnson & Johnson pulled the device from the market after an FDA warning in April about the risks of spreading cancer. Many hospitals have placed a moratorium on the use of power morcellators, but some gynecologists continue to use the tool, The Wall Street Journal reported. These doctors say they believe the risks have been overblown and the government should not interfere with their treatment choices. According to the FDA’s latest analysis, one in 352 women undergoing hysterectomy or fibroid removal has sarcoma, an aggressive, hard-to-detect cancer, which could be spread if a power morcellator is used in her surgery.

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