FDA Discourages Power Uterine Morcellation to Treat Fibroids
April 23, 2014 | Strategic Insights for Health System
Based on currently available information, the U.S. Food and Drug Administration (FDA) discourages the use of laparoscopic power morcellation to remove the uterus or uterine fibroids, states an April 17, 2014, FDA safety communication. An estimated 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids has an unsuspected uterine sarcoma. FDA believes that laparoscopic power morcellation poses a risk of disseminating unsuspected cancerous tissue beyond the uterus. Instead, healthcare providers and patients should consider all available treatments and thoroughly discuss the risks and benefits of each. Alternatives include traditional surgical hysterectomy and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery, high-intensity focused ultrasound, and drug therapy.