Power morcellation rates plunged after FDA warnings

Use of electric power morcellation for hysterectomy procedures has significantly declined after the FDA warned against the use of such devices in 2014, according to a new study.

Data from the study was published this month in the Journal of the American Medical Association.

The study examined a total of 203,520 women who underwent hysterectomy procedures from 2013 to the 1st quarter of 2015 as recorded in the Perspective database, which includes more than 500 hospitals in the U.S.

Researchers found that the use of power morcellators peaked in the 4th quarter of 2013 at 13.7%, and dropped to only 2.8% by the 1st quarter of 2015, according to the report.

The overall rate of complications did not change over the time, the study reported, while the rate of complications for declined for abdominal hysterectomies but were stable for minimally invasive hysterectomy and vaginal hysterectomy procedures.

“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,” study authors wrote.

The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.

The FDA in April 2014 issued a warning about the devices, later convening a special advisory panel to evaluate their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas, including the deadly leiomyosarcoma. In November of that year, the FDA ordered so-called “black box” warnings for the labels on morcellators, advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.

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