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Sales Halted for Uterine-Fibroid Surgery Device
– Reported, May 03 2014
Sales of a device used in surgery to remove uterine fibroids have been halted due to concerns that they may worsen a rare but deadly type of cancer, Johnson & Johnson said Tuesday.
The company noted that while worldwide sales, distribution and promotion of the device — called a morcellator — have been suspended, it will not be taken off the market, the Wall Street Journal reported.
J&J took the action after the U.S. Food and Drug Administration warned doctors on April 17 that using a morcellator to remove uterine fibroids risked worsening a type of cancer called uterine sarcoma.
The FDA said 1 in 350 women who undergo uterine fibroid surgery have undetected uterine sarcoma, WSJ reported.
An FDA advisory committee will meet this summer to more closely examine morcellator use during uterine fibroid surgery. In a letter to customers, J&J said it was awaiting input from the FDA and the medical community.