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FDA Warns That Laparoscopic Power Morcellators Used in Hysterectomy and Fibroid Removal May Spread Cancerous Tissue

4/17/2014

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The FDA has issued a new warning about laparoscopic power morcellators, the medical devices used during minimally invasive surgeries such as hysterectomy and uterine fibroid removal.  Morcellation is the process by which the tissue is divided into smaller pieces or fragments in order to remove it through the small incision sites.  The FDA reports that when used for hysterectomy or fibroid removal, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue beyond the uterus.  

Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus.  Most women will develop uterine fibroids at some point, but most fibroids cause no symptoms.  In some cases, however, fibroids can cause symptoms including heavy or prolonged menstrual bleeding, pelvic pain, and/or frequent urination, requiring medical therapy or surgery.  

Women often choose laparoscopic surgery over traditional abdominal surgery because of the shorter recovery time and reduced risk of infection.   However, if there is an unsuspected uterine cancer, the process of breaking up the tissue to remove from the small incision may spread cancerous tissue.  Therefore, the FDA is now discouraging the use of laparoscopic power morcellation during hysterectomy and the removal of uterine fibroids and is encouraging doctors and patients to carefully consider alternative treatment options.

[1] FDA Safety Communication, "Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication," April 17, 2014.

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