J&J Halts Sales of Device Used in Uterine Fibroid Surgery
Wednesday, April 30, 2014 (Last Updated: 05/01/2014)
WEDNESDAY, April 30, 2014 (HealthDay News) -- Morcellator sales have been halted due to concerns that use of the device in fibroid removal may worsen undetected uterine sarcoma, Johnson & Johnson said Tuesday.
The company noted that while worldwide sales, distribution, and promotion of the device 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 uterine sarcoma. The FDA said that one in 350 women who undergo uterine fibroid removal procedures 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.
Hematology & Oncology
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