FDA issued a
guidance against use of Ultrasonic Surgical Aspirators for removal of uterine
fibroids because of risk of unintended spread of uterine cancer in the process
of suction by the aspirators, thereby, worsening the patient’s odds for
survival.
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.
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.”
However,
when it comes to removing uterine fibroids, the risk of spreading occult cancer
is not outweighed by the benefits, "particularly since there are
alternative treatment options available," the FDA stated. The agency noted
that there is "no reliable preoperative screening procedure to detect
uterine sarcoma in women with presumed benign fibroids."
Under this
guidance, the FDA also requires the manufacturers to add a contraindication
label to labeling of the devices, with or without 510(k) clearances, within 120
days of the Oct. 30 release of the guidance: CONTRAINDICATION:
This ultrasonic surgical aspirator device is not indicated for and should not
be used for the fragmentation, emulsification, and aspiration of uterine
fibroids.
ACOG has however openly opposed the
FDA guidance against use of ultrasonic aspirators for fibroid removal by
stating it to be “too rigid and eliminates patient choice.” ACOG also disagrees
with FDA regarding existence of other safer alternatives to remove the fibroids
and claims that abdominal hysterectomy carries more risk.
The US FDA has already issued a communication
discouraging the use of power morcellator was issued on April 17, 2014 and have
resulted in 4% decline in rate of laparoscopic hysterectomies, says the results
of cross sectional study published in forthcoming issue of Journal Obstetrics
and Gynecology.
FDA issued the statement because of
advocacy and anti-morcellator campaign by Amy Reed, MD, PhD, an
anesthesiologist who died because of uterine leiomyosarcoma on
Wednesday, May 24 at age of 44.
She underwent a laparoscopic
hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was
upstaged because of dispersion in abdominal cavity by the use of power
morcellator. Since then, the power morcellator is the focal point of a four-year debate that has divided the surgical field.
Based on an analysis of currently
available data, the FDA has estimated that approximately 1 in 350 women who
undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected
uterine sarcoma.
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