The withdrawal of the power morcellators follows on just weeks after the US Food and Drug Administration (FDA) held hearings on the risk for cancer associated with the surgical device. A spokesperson for Ethicon said this is not a recall. In a corporate statement, Ethicon noted that its morcellators are not inherently defective; they functioned as designed. However, hospitals are being asked to return the devices.
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In April, the FDA issued a 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, the FDA 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.