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Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States

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Washington, DCThe US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.

The concern around the use of ultrasonic aspirators appears to be similar to that of power morcellators, in that the device could inadvertently spread cancerous cells during procedures to remove uterine fibroids.

Ultrasonic aspirators are used surgically to break up both hard and soft tissues with ultrasound energy. The device then sucks out the broken up tissue from the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures.

The FDA states in its guidance document that despite the suction of the ultrasonic aspirator, the oscillating tip of the device can disperse the fragmented tissue, which poses a risk of spreading cancerous tissue. Therefore, the agency states that in removing uterine fibroids, the benefits do not outweigh the risks, "particularly since there are alternative treatment options available," the FDA states.

Accordingly, the FDA is recommending the following addition to labels for ultrasonic aspirators indicated for 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."


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