Laparoscopic power morcellation is one of several treatments available for removal of the uterus (hysterectomy) and uterine fibroids (myomectomy). This procedure uses a medical device to divide the uterine tissue into smaller pieces so it can be removed through a small incision in the abdomen, allowing for a shorter recovery time.
Recent analysis of available data illustrates a significant risk of spreading unsuspected cancerous tissue beyond the uterus. According to the FDA, 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.
In a statement issued by William Maisel, M.D., M.P.H. of the FDA’s Center for Devices and Radiological Health, he discouraged the procedure: “The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients. 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.”
Currently, the FDA is gathering input from clinical and scientific experts regarding whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators so that patients and health care professionals are informed of the risks of this procedure. The FDA has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information.
If you or someone you know has undergone a laparoscopic power morcellation and now are facing a cancer diagnosis, please contact Slack & Davis for a free consultation with our experienced medical device litigation team, which includes a full-time legal nurse consultant.