Laparoscopic power morcellators used to treat uterine fibroids in women could spread cancer, according to the U.S. Food and Drug Administration (FDA). This could potentially turn a sometimes painful, but treatable condition into something far more dangerous.
The FDA recommends that laparoscopic power morcellators should not be used to remove fibrous tissue during myomectomies, or for hysterectomies (removal of the womb). They are used to "slice" pieces of the fibroid tissues, allowing removal of the material through a small, minimally-invasive incision.
"Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy," the Food and Drug Administration reported in an safety communication issued by the FDA in April 2014.
Roughly one out of every 350 women undergoing surgeries for hysterectomies or removal of fibroid tissues exhibit the uterine cancer which has not been diagnosed. Officials from the FDA believe these women are put at significant risk by the medical devices.
The federal agency is recommending manufacturers of the devices include a new boxed warning, advising doctors of the risk.
"Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices," the FDA warning advises.
The FDA warning also recommends a pair of additional contra-indications, stating when treatments and medicines should not be administered. The first of these advises health care professionals not to undertake the treatment during the time of life when many women first develop uterine fibroids.
"Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal," FDA officials stated in the new warning. This warning covers women currently experiencing menopause or those who are past their change of life.
In July 2014, the FDA sponsored a meeting of the Obstetrics and Gynecology Devices Panel, in an effort to determine the populations for which the devices should be discouraged. This group determined the need for the new warnings, and discussed other mitigation strategies. In their findings, they stressed the need for doctors to discuss dangers of the devices with their patients.
The FDA recommends development of other methods to prevent cancer deaths, such as improved detection techniques.
