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Power morcellation use declines following FDA safety warning

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August 23, 2016

The use of power morcellation among women undergoing minimally invasive hysterectomy significantly decreased in the wake of an FDA recommendation against its use, according to a research letter published in JAMA.

The use of abdominal hysterectomy increased during this period, results also showed.

Jason D. Wright, MD
Jason D. Wright

Electric power morcellation may cause the spread of undetected gynecologic malignancies. The FDA issued a safety communication to discourage use of power morcellation in April 2014. In November 2014, the FDA recommended against power morcellation in perimenopausal and postmenopausal women.

Some have suggested that the FDA’s communications against power morcellation may result in an increase of hysterectomies via laparotomy, which may result in increased complications.

Jason D. Wright, MD, clinical associate professor and division chief of gynecologic oncology at Columbia University Medical Center, and colleagues sought to observe trends in hysterectomy method (abdominal, minimally invasive or vaginal), power morcellator use, and abnormal pathology before and after the FDA’s April 2014 safety alert.

Wright and colleagues used the Perspective database to identify 203,520 adult women (mean age, 48 ± 12 years; range, 18-95) who underwent hysterectomy between 2013 and the first quarter of 2015. The researchers stratified patients by route of hysterectomy; 58% (n = 117,653) underwent minimally invasive hysterectomy.
evaluated among women who underwent power morcellation included uterine cancer, other gynecologic malignancies, uterine tumors of indeterminate potential and endometrial hyperplasia.

The proportion of hysterectomies that were minimally invasive declined from 59.7% (95% CI, 59-60.4) during the fourth quarter of 2013 to 56.2% (95% CI, 55.3-57.2) during the first quarter of 2015 (P < .001).

Power morcellation accounted for 13.5% (95% CI, 13-14.1) of minimally invasive hysterectomies in the first quarter of 2013, reaching a peak usage of 13.7% (95% CI, 13.2-14.2) in the fourth quarter of 2013. However, power morcellation use declined to 2.8% (95% CI, 2.4-3.1) in the first quarter of 2015, following FDA recommendations (P < .001).

Abdominal hysterectomy use increased from 27.1% (95% CI, 26.4-27.7) in the first quarter of 2013 to 31.8% (95% CI, 30.9-32.7) in the first quarter of 2015 (P = .004).

The overall complication rate did not significantly change during the study period (first quarter of 2013, 8.3%; first quarter of 2015, 8.4%; difference, 0.1%).

However, the incidence of complications declined among women who underwent abdominal hysterectomy (first quarter of 2013, 18.4%; first quarter of 2015, 17.6%; P < .001 for trend), which the researchers attributed to a decline in intraoperative complications (first quarter of 2013, 7%; first quarter of 2015, 6.1%; P = .001 for trend).

Complication rates remained stable for minimally invasive hysterectomy (first quarter of 2013, 4.4%; first quarter of 2015, 4.1%) and vaginal hysterectomy (first quarter of 2013, 4.7%; first quarter of 2015, 4.2%).

The incidence of uterine cancer, endometrial hyperplasia, gynecologic cancers and uterine tumors of indeterminate behavior did not significantly change among women undergoing power morcellation.

The researchers acknowledged limitations of their analysis, including the potential misclassification of pathology and the potential undercapture of power morcellation.

“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection,” Wright and colleagues wrote. “However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology. Continued caution is needed to limit the inadvertent morcellation of uterine pathology.” – by Cameron Kelsall

Disclosure: The researchers report no relevant financial disclosures.

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