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Home E-Weekly August 15, 2017

Is Revamped Morcellator Safe?

Published: August 14, 2017

CATCH ALL The PneumoLiner bag acts as a barrier between target and non-targeted tissue.

Will a new morcellator that comes with a bag intended to prevent cancerous tissue from escaping during power morcellation reduce the risk of spreading cancer? Olympus Medical plans to test its redesigned device in 140 hysterectomy patients in a clinical trial led by gynecologists at the University of North Carolina. Talk of the trial is igniting debate over whether the troubled gynecological device's spinning blades can spread cancerous tissue within the abdomen and pelvis.

Olympus's Contained Tissue Extraction System features a PneumoLiner bag that catches potentially cancerous cells. Intended for use with Olympus's laparoscopic PK Morcellator, the system provides certain patients with a laparoscopic surgery option to avoid open hysterectomy and myomectomy for uterine fibroid removal, says the company.

The FDA's April 2016 approval of the PneumoLiner bag came with some important caveats: Healthcare providers must share the potential risks of the device with patients, including that the use of laparoscopic power morcellators during fibroid surgery can spread cancer and that the FDA has warned against using a morcellator in the majority of women with uterine fibroids. The FDA also requires the product information to warn that it "has not been clinically demonstrated to reduce the risk" of spreading cancer.

The planned clinical trial has drawn the ire of Hooman Noorchashm, MD, a cardiothoracic surgeon in Philadelphia, Pa., who in May lost his 44-year-old wife Amy Reed, MD, a Philadelphia-area anesthesiologist, to uterine leiomyosarcoma after she underwent a power morcellation procedure in 2013. Dr. Noorchashm believes the technology caused his wife's cancer to spread and has become an advocate for increasing the awareness of the dangers associated with morcellation. He has contacted UNC to express his concerns about the design and ethics of the planned trial.

Kate Luck, a spokeswoman for UNC, says the university is committed to protecting the rights, safety and welfare of research participants. "Consistent with this commitment, we take seriously any questions or concerns arising from third parties about our research studies," she adds. "Our institutional review board is currently reviewing the matters Dr. Noorchaschm raised. At the conclusion of this review, we will provide further information."

Ms. Luck notes that the study is not yet open for participation recruitment. Olympus did not respond to a request for comment.

About 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma, according to the FDA. The agency says the PneumoLiner has not been proven to reduce the spread of potentially cancerous tissue during power morcellation and is intended as an alternative to more invasive surgery only in very limited cases, including women without uterine fibroids undergoing hysterectomy and some premenopausal women with fibroids who want to preserve fertility.

"This new device does not change our position on the risks associated with power morcellation," says William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids."

Daniel Cook

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