Health Canada Issues Updated Warning on Power MorcellatorsDec 15, 2014
Health Canada, the nation's health regulatory agency, has issued updated safety information on power morcellators. In a Safety Notification issued on December 10th, the agency stated that new information should be added to the warning labels of power morcellators
Power morcellators have become a subject of safety concerns because they can spread the risk of a hidden cancer. These tools are used in minimally invasive, or laparoscopic uterine procedures; they cut up tissue into smaller pieces so they are more easily removed through small incisions. If there is a hidden cancer however, morcellators can spread the cancerous tissue and worsen a patient's diagnosis.
In May, Health Canada warned about the risk of spreading cancer when using morcellators in laparoscopic hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) to treat benign fibroids. It is estimated that 1 in 350 women undergoing this procedure has an undetected cancer.
According to the updated notification, Health Canada has asked manufacturers to include new warnings on the labeling of morcellators. The agency wants the labels to state “Uterine tissue may contain unsuspected cancer. The use of laparoscopic electric 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.”
Health Canada also wants the labels to mention contraindications; the agency says the tools should not be used “for the removal of uterine tissue containing suspected fibroids in patients who are (i) peri- or post-menopausal, or (ii) candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.” The devices are also contraindicated “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”
The agency notes that efficacy of using bags to contain potentially cancerous tissue during morcellation is undetermined.
The U.S. Food and Drug Administration (FDA) has also warned about power morcellators and the risk of spreading an occult cancer. Last month, the agency said that the devices should no longer be used in uterine surgeries for “the vast majority” of women.