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FBI Targets J&J Over Morcellator Cancer Risk: WSJ
May 27, 2015
2 Min Read
The Wall Street Journal cited "people who have been interviewed by the agency."
The Gynecare Morcellex Tissue Morcellator, as shown on Ethicon's website.
The FBI is looking into what Johnson & Johnson officials knew about the dangers of power morcellators spreading cancer when they sold the once-popular surgical device, according to The Wall Street Journal.
A J&J spokesman told the newspaper that the company is unaware of an FBI inquiry into laparoscopic power morcellators.
The news comes just weeks after Aetna said that it will not pay in most cases for the use of power morcellators in myomectomies or hysterectomies.
The decision came amid FDA warnings that the spinning blades of the once-popular devices can spread unsuspected uterine sarcoma in the abdomen and pelvis.
Johnson & Johnson's Ethicon subsidiary already pulled its morcellators from the market last year, including the Gynecare Morcellex tissue morcellator, Morcellex Sigma tissue morcellator, and the Gynecare X-tract tissue morcellator.
The problems surrounding the morcellators have not only affected the companies that make them, such as Ethicon, but also companies such as Intuitive Surgical, which makes surgical robots for the early stages of hysterectomies, before morcellation takes place.
FDA now estimates that 1 in 350 women undergoing hysterectomy or myomectomy might have such an unsuspected uterine sarcoma, which is higher than previously estimated, Aetna spokeswoman Cynthia Michener noted via email.
When it comes to power morcellators, the "safety and efficacy of this approach has not been demonstrated," Michener said.
The Wall Street Journal first raised concerns about morcellators in late 2013. WSJ reported in March that doctors have already found other noninvasive ways to perform hysterectomies. Most are instead engaging in a "mini-laparotomy" that involves removing the uterus through a tiny incision above the pubic bone.
Refresh your medical device industry knowledge at MD&M East in New York City, June 9-11, 2015.
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