Ultrasonic surgical aspirators should not be used to remove uterine fibroids because there is a risk that the devices could cause the unintended spread of uterine cancer, worsening the patient’s odds for survival, the Food and Drug Administration (FDA) said. The agency issued a nonbinding guidance recommending that companies that make a devices label them with a contraindication for uterine fibroid removal due to this risk.
Ultrasonic aspirators are devices fitted with an oscillating tip that break up and emulsify both hard and soft tissues into fragments with ultrasound energy and then remove them from the body through a small incision. They are used by a wide variety of surgeons for both open and laparoscopic procedures, including the cytoreduction – or the removal of cancer cells – of advanced malignancies that cannot be completely removed. Some devices are specifically for removing uterine fibroids.
The FDA says that the devices carry a similar risk as power morcellators, devices fitted with a tube-like blade that minces uterine growths or entire uteruses within the body and removes them through a small incision in the abdomen. Power morcellators have come under scrutiny for these procedures in recent years because they can fling bits of cancerous tissue throughout the abdomen, spreading cancer and making the disease more difficult to treat. In November 2014, a black box warning regarding cancer spread was added to the device’s label.
In the case of cytoreduction, ultrasonic aspirators can offer more extensive tumor removal, little or no collateral thermal damage, and the ability to avoid organ resection. However, the agency said that the risk of cancer outweighs any benefits ultrasonic aspirators offer, “particularly since there are alternative treatment options available,” the agency said.
As a result, the FDA is recommending that companies that sell ultrasonic aspirators add to the products’ labels the following language in regard to laparoscopic, open or gynecologic surgery: “Contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.”