Health Canada Warns About Risk that Uterine Surgery Tool May Spread Cancer

In a Notice to Hospitals, Canada’s national health regulatory agency, has warned about the use of laparoscopic morcellators during hysterectomies and surgeries for uterine fibroids.

The notice warns that the use of a morcellator during minimally invasive hysterectomy or fibroid surgery may result in the spread and “upstaging” of an undetected uterine cancer.  These cancers cannot “reliably” be detected preoperatively, according to Health Canada. The frequency of such unsuspected uterine cancer is estimated to be about 1-in-350, a higher rate than previously reported.

The power morcellator uses rapidly spinning blades to cut uterine tissue into small pieces that can be removed through tiny incisions.  But when the woman has an undetected cancer, the morcellator can spread cancerous tissue in the patient’s abdomen, leading to a more aggressive cancer and diminishing the woman’s overall survival rate.

Health Canada is working with device manufacturers to revise the instructions for morcellator use. The agency is requesting that manufacturers include the following warnings in the labeling of electric morcellators:

• 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’s notice says the use of the device is contraindicated:

• 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.

• in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

Health Canada says the risks and benefits of using tissue extraction bags to contain tissue released during laparoscopic electric morcellation procedures have not been determined.

The U.S. Food and Drug Administration (FDA) has recently issued similar warnings and labeling cautions, though the FDA stopped short of banning the device altogether.