FDA: Don't Remove Uterine Fibroids With Ultrasonic Aspirators
October 31, 2017
Excerpts:
Companies that make ultrasonic surgical aspirators should label them as contraindicated for removing uterine fibroids because they could inadvertently disseminate occult cancer,
the US Food and Drug Administration (FDA) said yesterday.
The nonbinding guidance from the FDA reprises the agency's warnings about power morcellators and rekindles the debate in medicine over the risks and benefits of laparoscopic fibroid surgery.
Ultrasonic aspirators are multifunctional devices that break up and emulsify both hard and soft tissues with ultrasound energy and then suck them out of the body through a small incision.
They're used by a wide variety of surgeons in both open and laparoscopic procedures, including the cytoreduction of advanced malignancies that can't be removed completely.
Some devices are explicitly indicated for removing uterine fibroids, while other devices have more general indications —
that is, for laparoscopic, open, and gynecologic surgery — that can be interpreted to include fibroid removal, according to the FDA. . . .
. . . The agency noted that there is "no reliable preoperative screening procedure to detect uterine sarcoma in women with presumed benign fibroids."
Accordingly, the FDA said it was 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."
[Full article at link above and, of course, be sure to search other literature, too.] -
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