Devices

Guide on Labeling for Ultrasonic Surgical Aspirator Devices

FDA has released a guidance entitled: “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices” that describes the agency’s current thinking on such devices’ labeling and makes recommendations. The devices are commonly used in procedures to break down, liquefy, and remove hard and soft tissue.

“Although the agency is not aware of evidence to suggest health care providers are routinely using aspirators for fibroid removal, the labeling of certain ultrasonic surgical aspirator devices includes an indication for use in patients with symptomatic uterine fibroids,” the guidance says. “Since there are currently no reliable preoperative screening procedures to detect uterine sarcoma in women with presumed benign fibroids, there is a chance that women undergoing surgery to remove fibroids using an aspirator may have an unknown cancer. Use of an aspirator on uterine fibroids in a woman with an unknown uterine sarcoma could cause the cancer to spread. This risk outweighs any potential benefits in this patient population, particularly since there are alternative treatment options available.”

The guidance recommends manufacturers of ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, or gynecologic surgery do the following:

include a contraindication in the product labeling stating that the device should not be used to remove uterine fibroids; and
review and update other portions of the device’s labeling to be consistent with this contraindication.

The agency notes that the guidance does not apply to aspirators specifically indicated for other surgical subspecialties, such as gastrointestinal and affiliated organ surgery, urological surgery, and neurosurgery.

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