Draft Guidance: FDA Calls for Contraindication for Ultrasonic Surgical Aspirators

Regulatory NewsRegulatory News | 09 November 2016 |  By 

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance recommending a contraindication and label changes for some ultrasonic surgical aspirators in light of the risk for the devices to spread cancer cells if used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.

According to FDA, these devices are commonly used to "debulk" malignant tumors. Similar to power morcellators, the agency says that these devices could lead to the dissemination of cancer cells to other parts of the body when used to remove uterine fibroids in women with uterine sarcoma.

"In light of the risk of tissue dissemination from the use of these devices, the FDA is providing specific labeling recommendations in this draft guidance to promote the safe and effective use of ultrasonic surgical aspirator devices," FDA writes.

However, while the labeling of some ultrasonic surgical aspirators would allow for the use of uterine fibroid removal, FDA says it is "not aware of these devices being used for this purpose."

Specifically, FDA says the labeling recommendation will apply to devices intended for general surgery, laparoscopy and gynecologic surgery that are classified under product codes LFL (Instrument, Ultrasonic surgical) and NLQ (Scalpel, Ultrasonic, Reprocessed). However, guidance would not apply to devices within those codes that do not aspirate tissue as part of their function or devices indicated for other types of surgery, such as gastrointestinal, urological or neurosurgery.

For devices that fall under the scope, FDA says device makers should update their product labeling within 120 days of the final guidance being issued to include the following contraindication:

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

FDA also calls on sponsors to review and update the rest of their labeling to ensure it is consistent with the new contraindication and submit both versions of the labeling to the agency within the 120 day window.



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