Power Morcellator Use Drops in Light of FDA Warning

The use of power morcellators in gynecologic procedures has decreased substantially after the U.S. Food and Drug Administration (FDA) warned in 2014 that the devices could spread undetected uterine cancers. A study published in JAMA examined trends in power morcellation among women undergoing a hysterectomy. Researchers found that in the first quarter of 2013, 13.5 percent of minimally invasive hysterectomies involved the use of a power morcellator. By the first quarter of 2015, after the FDA issued its safety communication, usage dropped to 2.8 percent.

Power morcellators are used to cut up tissue into smaller pieces, making them easier to remove through small incisions during a minimally in invasive surgery. In 2014, the FDA discouraged use of the devices due to its cancer-spreading risks. In November 2014, the agency advised against the use of power morcellators in perimenopausal and postmenopausal women. The issue is that some women undergoing a minimally invasive gynecologic procedure have a uterine cancer that is not reliably detected before surgery. This cancer can masquerade as a uterine fibroid, and morcellating the malignant tissue can spray the cancer cells through the pelvic area, greatly worsening a patient’s prognosis.

Concerns over power morcellators were brought to light by husband-and-wife physicians Hooman Noorchashm and Amy Reed. Dr. Reed shared her own personal story after undergoing a procedure with a morcellator. Her previously undetected sarcoma was greatly worsened, or “upstaged”, following morcellation. The couple have become advocates and made it their mission to raise awareness. It was previously believed that these hidden cancers were extremely rare, but now it is known that 1 in 350 women undergoing morcellator procedures may have a hidden uterine cancer.

The JAMA study involved data from 203,520 adult women who underwent a hysterectomy between 2013 and the first quarter of 2015. In the fourth quarter of 2013, 59.7 percent of hysterectomies were minimally invasive. This decreased to 56.2 percent during the first quarter of 2015. Researchers found that the overall complication rate did not change significantly during the study period.

“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection,” the authors 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.”

In light of morcellator concerns, U.S. Reps. Louise Slaughter, D-N.Y. and Michael Fitzpatrick, R-Pa. introduced the Medical Device Guardians Act of 2016. Under the new bill, doctors would be required to report medical device problems to the FDA. Currently, this is only required of hospitals and manufacturers. Physicians are already required to report drug-related injuries. The bill is meant to identify medical device hazards as early as possible.

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