The suspension follows on from a recent Food and Drug Administration (FDA) safety communication discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
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Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.
The FDA is planning to convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.