The FDA is discouraging doctors and patients from using laparoscopic power morcellation for the removal of the uterus (hysterectomy) or the removal of uterine fibroids (myomectomy) since it could spread unsuspected cancerous tissue beyond the uterus. It has released a safety communication with its recommendations for physicians and for women that warns of the risks and lists considerations for parties who will perform or undergo hysterectomies and myomectomies, including alternative treatment options. The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Device Panel to gain “input from clinical and scientific experts.”
Most women will develop uterine fibroids (leiomyomas), noncancerous tumors that arise from uterine muscular tissue, at some point during their lives. While generally not problematic, leiomyomas can become symptomatic, causing heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes growing to the size of cantaloupes, and may necessitate medical or surgical treatment. Surgical options include traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. More than 200,000 hysterectomies are performed each year for uterine fybroids. Laparoscopic power morcellation involves the use of a power morcellator to divide uterine tissue into small pieces or fragments that are removed through an incision in the abdomen. Patients sometimes choose a laparoscopic procedure because it is associated with a shorter post-operative recovery time and a reduced risk of infection.
According to 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.” The FDA has determined that one in 350 women undergoing a hysterectomy or myomectomy due to fibroids will unknowingly have uterine sarcoma, a rare form of cancer that usually develops after menopause. Laparoscopic power morcellation in these women could spread cancerous tissue from the uterus to the abdomen and pelvis, “significantly worsening the patient’s likelihood of long-term survival.” Previously, the threat of spread was thought to be less common, affecting anywhere from one in 500 to one in 10,000 women.
In light of this information, the FDA has instructed manufacturers of power morcellators used in laparoscopic hysterectomies and myomectomies to review their current labeling to ensure that it includes accurate risk information. It has also advised physicians not to use the procedure in patients with suspected or known cancer. Physicians who deem the procedure the best option should discuss the risks with their patients. The FDA notes that some clinicians and medical institutions advocate the use of a specimen bag during morcellation to attempt to contain the uterine tissue and minimize the risk of spreading it. Women who have previously undergone the procedure and whose tissue tested normally (at noncancerous levels) should undergo routine follow-up with their physicians.
When the FDA convenes a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee, in addition to discussing the clinical role of laparoscopic power morcellation to treat uterine fibroids, it will discuss the use of a specimen bag and other surgical techniques that could reduce risks, as well as whether a boxed warning related to the risk of cancer spread should be required for laparoscopic power morcellators.