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Medical Devices / Postmarket Safety

FDA Adds Contraindication to Labeling of Certain Ultrasonic Surgical Aspirator Devices

Nov. 8, 2017

The FDA has recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids.

In a new labeling guidance document for manufacturers of such devices with indications for use in laparoscopic surgery, open surgery or gynecologic surgery, the agency explained that using the devices during the treatment of symptomatic uterine fibroids on a woman with an occult uterine sarcoma could result in dissemination of the cancer, a risk that outweighs the potential benefits.

The agency said the following contraindication should be added to labeling of the devices, with or without 510(k) clearance, within 120 days of the Oct. 30 release of the guidance:

CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

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