Questioning the FDA estimate of occult sarcoma

November 20, 2015

Dispatches from the 44th AAGL Global Congress looks at the incidence of occult sarcoma and a look at what patient characteristics may lead to using morcellation during hysterectomy.

Results of a study of minimally invasive hysterectomies presented at the 44th AAGL Global Congress casts new light on the oft-quoted incidence of occult sarcoma included in the Food and Drug Administration (FDA) warning about use of power morcellation. The large single-surgeon experience, the author said, suggests that the 1 in 350 estimate of the disease’s diagnosis following hysterectomy for a benign indication may be too high.

More: Claim of unnecessary hysterectomy

The retrospective observational study reflects outcomes from 1432 consecutive patients in a private practice in Scottsdale, AZ. Done for benign conditions, the minimally invasive hysterectomies were performed in hospitals and ambulatory surgery centers.

Preoperative indications included abnormal bleeding (52.09%), enlarged uterus (18.02%), and pelvic prolapse (15.36%). None of the procedures resulted in a postoperative diagnosis of uterine sarcoma, whereas 45.39% of the women were ultimately diagnosed with leiomyomata and 29.33% with no pathology. The surgeries performed were laparoscopic supracervical, total laparoscopic, and vaginal hysterectomies.

Mechanical morcellation was employed during all 674 laparoscopic supracervical hysterectomies versus 120 (21%) of the laparoscopic surgeries and none of the vaginal surgeries. In 230 (43%) of the total laparoscopic hysterectomies, manual morcellation was used, as was the case in 86 (48%) of the vaginal procedures. Overall, 775 of the hysterectomies involved morcellation (55% mechanical, 22% manual).

Demir RH. Incidence of uterine sarcomas in 1432 consecutive minimally invasive hysterectomies. J Min Invasiv Gynecol. 22 (2015) S35 Abstract 87. Presented Tuesday, November 17, 2015 in Las Vegas, Nevada.

NEXT: Vaginal morcellation and patient characteristics


Patient characteristics and vaginal morcellation

Youth, body habitus, and presence of uterine leiomyomata in a patient are factors likely to trigger use of morcellation during vaginal hysterectomy, according to results of a 5 ½-year study presented at the 44th AAGL Global Congress. The findings are from a retrospective cohort at an academic medical center.

A total of 743 women who underwent total vaginal hysterectomy at Mayo Clinic Arizona between January 1, 2009 and August 31, 2015 were included in the analysis.  Among the cohort, 383 had their uteri removed intact and 360 had morcellation.

Next: Impact of FDA's power morcellation safety communication

Characteristics associated with a higher likelihood of morcellation included younger age, higher uterine weight, non-Caucasian race, higher American Society of Anesthesiologists class, lack of prolapse requiring colporrhaphy, and pathologically confirmed uterine leiomyomata. The multivariate logistic model used by the authors to determine the factors that influenced morcellation resulted in an area under the curve of 0.85, suggesting that it would be highly predictive of the use of the technology.

For every unit increase in body mass index, the authors said, the odds of morcellation increased by 3.8%, whereas those odds decreased by 5.9% for every year of increase in a woman’s age. The odds of vaginal morcellation being needed also rose when uterine pathology showed uterine leiomyomata.

Wasson MN, Butler KA, Temkit M, Magrina JF. Necessity of morcellation at time of vaginal hysterectomy. J Min Invasiv Gynecol. 22 (2015) S12 Abstract 29. Presented Wednesday, November 18, 2015 in Las Vegas, Nevada.