A Massachusetts couple who have done so much to bring attention to the cancer risks associated with power morcellators finally had a chance to tell their story to federal regulators, as they presented poignant testimony on the second day of a U.S. Food & Drug Administration (FDA) advisory panel meeting convened to address the issue, Bernstein Liebhard LLP reports. According to the Rochester Democrat and Chronicle, Dr. Hooman Noorchashm and his wife, Dr. Amy Reed, held back tears as they addressed the FDA’s Obstetrics and Gynecology Devices Panel. Dr. Noorchashm began by presenting a collage featuring photos of women who died, allegedly after they suffered the spread of undetected cancers due to uterine morcellation.
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.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”