U.S. FDA’s Canadian Counterpart – Health Canada – Follows the Lead with Stronger Warnings on Laparoscopic Morcellators, Used in Fibroid Surgeries and Hysterectomies

Following the FDA’s decision in November 2014, to beef up warning labels on laparoscopic morcellators, health officials in Canada are following suit, placing nearly identical labels on the surgical device to warn patients about the risk of spreading uterine cancer. The minimally invasive tool used during laparoscopic hysterectomies and myomectomies enables doctors to grind up the uterus or uterine fibroids and remove the tissue through a small abdominal incision, but the process has been linked to the spread of unsuspected cancer and other uterine diseases in women who undergo the procedure. In addition to the stronger warnings, Health Canada, akin to the FDA in the U.S., is also advising against use of the device in peri-menopausal and post-menopausal women, candidates for en bloc tissue removal, and for other gynecological surgeries—which effectively eliminates most morcellator use.