The US FDA
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.
The
researchers examined data from 4 states inpatient and ambulatory surgery
database for year 2013 to 2014, and compared the rates of laparoscopic
hysterectomy 15 months before and 9 months after the FDA announcement.
Women with a
diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included
in the analysis.
Total 77,637
hysterectomies and myomectomies were performed during that period. The rate of
laparoscopic hysterectomies declined from 62% of all hysterectomies before to
58% afterward with an accompanying increase in abdominal hysterectomies of 8% from
71% to 79%.
The rate of
myomectomies in women with leiomyoma remained the same as compared to hysterectomies.
On April 7,
2016 The U.S. Food and Drug Administration today permitted the marketing of the
first tissue containment system for use with certain laparoscopic power
morcellators to isolate uterine tissue that is not suspected to contain cancer.
"PneumoLiner
is intended to contain morcellated tissue in the very limited patient
population for whom power morcellation may be an appropriate therapeutic option
- and only if patients have been appropriately informed of the risks," FDA
deputy director William Maisel said in a news release.
"This
new device does not change our position on the risks associated with power
morcellation. We are continuing to warn against the use of power morcellators
for the vast majority of women undergoing removal of the uterus or uterine
fibroids," Dr Maisel added.
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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