AndrusWagstaffLogoTransThe FDA says that laparoscopic power morcellators—surgical devices commonly used to remove fibroid tumors from the uterus or the entire uterus—should not be used to perform these procedures in the vast majority of women because they can spread unsuspected cancer.

The FDA’s Immediately in Effect (IIE) guidance, issued November 24, updates a safety communication issued by the agency in April that discouraged doctors from using morcellators but didn’t ban them.

While the latest FDA announcement also doesn’t ban the devices it warns that in the vast majority of women, morcellation should not be performed. It also recommends that manufacturers include on morcellator packaging a boxed warning and two contraindications (cases where morcellators should not be used).

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