Devices

Ban ‘Uncontained’ Power Morcellators: Petition

Cardiac surgeon and anti-power morcellator activist Hooman Noorchashm is petitioning FDA to ban the use of “uncontained” laparoscopic power morecellator devices in gynecological operations involving resection of the uterus and its associated tumors. The 10/9 petition says recent epidemiological data from Yale University demonstrated that 2%-10% of women with gynecological uterine symptoms harbor an occult or missed cancer diagnosis.

Noorchashm says those findings follow a major women’s health controversy surrounding the incidence of occult Leiomysarcomas of the uterus in symptomatic women in which the FDA commissioner’s office has been intimately involved since 12/2013.

The petition notes that FDA issued a Boxed Warning against the use of laparoscopic power morcellator devices in the vast majority of women and reiterated that Boxed Warning 12/14/17.

“Unfortunately,” Noorchashm says, “despite the stern warnings from FDA and the current availability of an FDA cleared ‘contained’ power morcellator, many gynecological surgeons across the United States are continuing to utilize uncontained laparoscopic power morcellation and uncontained manual morcellation techniques as the means of extracting resected uterine tissue through small incisions…. Therefore, in order to prevent the premature or unnecessary deaths of any more unsuspecting American women from upstaged occult/missed cancers of the uterus, it is critical that the FDA commissioner immediately reconsider the new data on the incidence of gynecological cancer … as well as the availability of a FDA cleared ‘contained’ laparoscopic power morcellator, to ban all ‘uncontained’ versions of this device from the U.S. healthcare environment.”

Noorchashm has been a vocal critic of power morcellation devices for several years, including calling for the resignation of CDRH director Jeffrey Shuren. In 2017, his wife, Amy Reed, died from complications from disseminated uterine cancer following treatment with a power morcellator.

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