The U.S. Food and Drug Administration (FDA) recently issued a safety communication that the use of laparoscopic power morcellation to remove a patient's uterus (hysterectomy) or uterine fibroids (myomectomy) involves risk of spreading hidden cancers in women.
Every year thousands of women in the U.S. get uterine growths removed using a surgical procedure known as laparoscopic power morcellation. The process has been used for a long time to remove fibroid tumors attached to the walls of the uterus, and sometimes to remove the uterus. Power morcellation involves inserting an electric device through a small incision in a patient's abdomen that then slices off fibroid or uterine tissue, divides it into smaller pieces and removes those pieces.
The FDA says that based on the data analysed, around one in 350 women who are undergoing hysterectomy or myomectomy for fibroids possess uterine sarcoma, which is an unsuspected type of uterine cancer. The FDA suggests that the use of laparoscopic power morcellation may put the patient at risk of spreading the cancerous tissue in the abdomen and pelvis, which may significantly reduce the patient's 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 Dr. William Maisel, 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."
Maisel also added that input from experts will enable the FDA to get a clear picture of the proper clinical role for the process. One possible result Maisel said could happen after discussions with clinical and scientific experts is that a "boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks."
For the time being, the FDA has asked laparoscopic power morcellator manufacturers to review their current labeling to make sure it provides accurate risk-related information to patients as well as health care professionals. It also recommends doctors not perform the procedure in women with suspected or known uterine cancer.
Other treatment options are available to deal with uterine fibroids that are causing problems. They include a traditional hysterectomy or myomectomy surgery that is performed either vaginally or abdominally; a laparoscopic hysterectomy and myomectomy without morcellation; and options that don't require surgery.
