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FDA Puts Black Box Warning On Power Morcellators With Immediately-In-Effect Guidance

FDA has followed through on the advice of its advisory panel by requiring new labeling for power morcellators used to treat uterine fibroids, emphasizing the procedure’s potential to spread cancer. FDA wants to restrict the power morcellation procedure to younger women who are interested in maintaining their ability to have children and who have been thoroughly informed of the risks.

FDA issued an Immediately-in-Effect guidance

on Nov. 24 recommending that labeling on laparoscopic power morcellators used to treat uterine fibroids include a boxed warning and two specific contraindications to reduce the risk of spreading...

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