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Sep 15, 2017

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Clinical trial stirs controversy over power morcellator bags

Morcellation of fibroid tissue has been under scrutiny since the discovery that the spinning blades from power morcellators can spread cancerous tissue within the abdominal cavity, significantly worsening a patient’s survival. In 2014, the FDA warned against the use of laparoscopic power morcellators “in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” Following the FDA recommendation, the number of minimally invasive hysterectomies that used power morcellation declined from 13.7% (95% CI, 13.2-14.2) in the fourth quarter of 2013 to 2.8% (95% CI, 2.4-3.1) in the first quarter of 2015 (P < .001), according to a study by Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, and colleagues. “The controversy surrounding the morcellator is that you’re essentially taking tissue and mincing it into smaller pieces in the abdominal cavity. If there is cancer [in the fibroid tissue], there is the potential that you can spread those cancer cells throughout the abdominal cavity,” Wright told HemOnc Today. “With morcellation occurring in a bag, theoretically, these cancerous fragments of tissue would not be able to spread.” The FDA estimates that approximately one in 352 women who undergo hysterectomy or myomectomy to remove presumed benign fibroids learns she has uterine cancer, and that one in 498 women has an unsuspected leiomyosarcoma. The FDA approved the PneuomoLiner bag in April 2016, noting that heath care providers must share with patients the potential risks of the device. The bag also must include a warning label stating it has not been clinically demonstrated to reduce the risk for spreading cancer.

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