In a study appearing in the August 23/30 issue of JAMA, Jason D. Wright, M.D., of the Columbia University College of Physicians and Surgeons, New York, and colleagues examined trends in the route of hysterectomy (abdominal, minimally invasive, or vaginal), use of electric power morcellators (a procedure in which the uterus is fragmented into smaller pieces, and may result in the spread of undetected malignancies), and prevalence of abnormal pathology before and after a Food and Drug Administration (FDA) warning.
Concern about the safety of electric power morcellation for gynecologic surgery led the FDA to issue a safety communication in April 2014 discouraging use of the devices and, in November 2014, to recommend against use of morcellation in perimenopausal and postmenopausal women. Concern has been raised that these actions may result in performance of a greater number of hysterectomies via laparotomy (surgical incision into the abdominal wall), with an increased risk of complications.
The study included women age 18 to 95 years who underwent hysterectomy from 2013 to the first quarter of 2015 recorded in the Perspective database, which includes more than 500 hospitals across the United States and approximately 15 percent of hospitalized patients. Outcomes were compared before and after the FDA's alert in April 2014.
The researchers identified 203,520 women, including 117,653 women (58 percent) who underwent minimally invasive hysterectomy. Among women who underwent minimally invasive hysterectomy, power morcellation was used in 13.5 percent in Q1 2013, peaked at 13.7 percent by Q4 2013, and declined to 2.8 percent by Q1 2015. The overall complication rate was unchanged over time. Complications declined for abdominal hysterectomy, attributable to a decline in intraoperative complications, but were stable for minimally invasive hysterectomy and vaginal hysterectomy. The prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior in women who underwent morcellation were unchanged.
"The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. 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," the authors write.
###
(doi:10.1001/jama.2016.9432; the study is available pre-embargo to the media at the For the Media website)
Editor's Note: This article was funded by grants from the National Cancer Institute. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Journal
JAMA