Boston Couple Leads Crusade Against Power Morcellator Use

Published on July 9, 2014 by Sandy Liebhard

The story of a Boston woman whose Stage 4 uterine cancer followed a laparoscopic hysterectomy last October has since become the catalyst for a public outcry against power morcellator use in the U.S.

A July 3rd report on The Cancer tells how the husband of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, launched a petition to end the use of power morcellators in minimally-invasive laparoscopic hysterectomy and fibroid removal surgeries. His wife is currently living with uterine cancer that may have been spread by a device that has already been named in power morcellator lawsuit filings.

As of July 9th, a total of 11,738 people had signed the petition to end uterine morcellation, a process that cuts up uterine tissue so that it can be more easily removed via a tiny incision.

The Cancer Letter reports that some 100,000 women undergo these types of procedures each year in the U.S., their rise in popularity owed to smaller patient scars and faster recovery times. Uterine morcellation came under fire in April though, when the U.S. Food and Drug Administration (FDA) issued a public health alert that discouraged doctors against using power morcellators in the future. 1 out of 350 women having fibroids removed have undiagnosed uterine sarcoma or another type of cancer that could be spread as a result of the bladed surgical tool, the federal agency said at the time. Following the FDA warning, companies including Johnson & Johnson’s Ethicon unit have suspended the manufacturing, marketing and sale of their power morcellators, and hospitals across the U.S. have stopped using them in gynecologic and laparoscopic procedures.

According to medical professionals quoted in the Cancer Letter, this would not have been possible without the petition’s creator, Hooman Noorchashm. “His work, unfortunately resulting from personal tragedy, has galvanized all of us to be very aggressive in developing better policies so that we can avoid this horrible result in the future,” said David Challoner, who serves as vice president for health affairs at the University of Florida.

Medical Professionals Take Issue with FDA Clearance Process

The article later points out that power morcellators first received market approval in 1995 via the FDA’s 510(k) process, which allows a product to bypass clinical human testing.

“There is no mechanism by which the health of the public could be protected when moderate risk devices were only cleared to the market place, not approved, under 510(k),” Challoner added.

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