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FDA Calls for Contraindication for Ultrasonic Surgical Aspirators
Nov 11, 2016
The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance recommending a contraindication and label changes for some ultrasonic surgical aspirators in light of the risk for the devices to spread cancer cells if used to remove uterine fibroids.
Ultrasonic surgical aspirators are used in numerous surgical areas, including general, orthopedic and gynecologic surgery, and are used to emulsify and aspirate tissues by delivering ultrasound energy to the targeted tissue...