, according to the Food and Drug Administration.
These devices have the potential to disseminate undetected tumor tissue, and there are no proven preoperative screening methods for detecting uterine sarcoma in uterine fibroids that otherwise appear to be benign, FDA officials wrote in a guidance document issued Oct. 30. The FDA is calling for new product labeling for these devices within 120 days.
The devices deliver ultrasonic energy through an oscillating tip, which leads to tissue fragmentation. This can lead to tissue dissemination that cannot be eliminated by suction/aspiration. In advanced cancers, the risk of dissemination may be outweighed by the benefits of the devices, including the debulking effect with no thermal collateral damage, as well as avoidance of the need for organ removal or resection.
The devices are currently labeled in a way that suggests they could be used in removing uterine fibroids, though the agency said that it is not aware that they are used for this purpose.
The agency recommended against their use in uterine fibroids, in part because there are alternative treatment options available. But the American College of Obstetricians and Gynecologists has challenged that assertion. When the FDA first issued a draft notice of the labeling guidance in November 2016, ACOG commented that abdominal hysterectomy is the alternative treatment option and is associated with significant morbidity and mortality beyond that seen with minimally invasive techniques. ACOG urged the FDA to prioritize informed consent and the weighing of risks and benefits.
Ultrasonic surgical aspirator devices are used for a wide range of surgical applications, but the recommendations apply specifically to laparoscopic surgery, open surgery, and gynecologic surgery.