In a guidance statement released October 30, the U.S. Food and Drug Administration (FDA) made a non-binding recommendation that the makers of ultrasonic surgical aspirators should label them as not recommended for removing uterine fibroids, because doing so could inadvertently spread occult cancer.
The FDA said that the device’s oscillating tip can disperse the tissue that it breaks up with ultrasonic waves, despite the fact that it is designed to suck up the tissue, and the risk of disseminating cancer cells is outweighed by the aspirator’s benefits, which include “more extensive tumor debulking, little or no collateral thermal damage, and the ability to avoid organ resection,” according to the statement.
Guidance Statement Sounds Familiar
This guidance from the FDA echoes earlier warnings regarding power morcellators and the risks and benefits of laparoscopic fibroid surgery. Like power morcellators, ultrasonic aspirators are devices that break up tissue and then remove it from the body through a small incision. Ultrasonic aspirators are used by a wide variety of surgeons in both open and laparoscopic surgical procedures, including for advanced malignancies that cannot be removed completely. Some such devices are explicitly recommended for uterine fibroid removal, while others have more general uses – for laparoscopic, open and gynecological surgery, which could be interpreted to include fibroid removal, according to the FDA.
It is unclear what prompted the October 30 guidance statement that was first proposed in November 2016, as the FDA said the agency knows of no circumstances when surgeons using ultrasonic aspirators to remove uterine fibroids spreading or upstaging uterine cancer. The American College of Obstetricians and Gynecologists (ACOG) previously agreed that the device was capable of spreading occult uterine cancer but said that the recommendation was “too rigid and eliminates patient choice,” and pointed out that abdominal hysterectomies present greater health risks.