The FDA has issued a warning against the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids after finding that the procedure, which uses a medical device to slice uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, poses a risk of spreading hidden cancerous tissue throughout the rest of their bodies.
While most uterine fibroids are non-cancerous, 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,” explained William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
“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,” he stated.
Fibroids are growths that originate from the smooth muscle tissue in the wall of the uterus.Though most are not problematic, they can result in symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy, according to the National Institutes of Health, which went on to state that “most women will develop uterine fibroids at some point in their lives.” Treatments include traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options. To learn more, women should consult with their gynecologists.