The FDA has released draft guidance on product labeling for ultrasonic surgical aspirator devices that it says will contribute to their safe and effective use.
The agency recommends that manufacturers of ultrasonic surgical aspirator devices with a general indication for use in general surgery, laparoscopy, or gynecologic surgery prominently include the following contraindication in their product labeling:
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the removal of uterine fibroids.
The FDA also recommends that manufacturers review and update other portions of their labeling to be consistent with this contraindication. For example, a manufacturer may revise the list of procedures in the labeling for which the ultrasonic surgical aspirator can be utilized.