FDA Cautions Against Use of Power Morcellators in Women Undergoing Laparoscopic Surgery for Uterine Fibroids
November 25, 2014
DOCUMENTS
- FDA Guidance
WASHINGTON, D.C. — The Food and Drug Administration has strongly cautioned against the use of laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids, explaining that it “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
The Nov. 24 updated Safety Communication, which is directed toward healthcare providers, patients and device manufacturers, warns that “while the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
“If laparoscopic power morcellation is performed in women with unsuspected uterine …
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