Health Canada Requires New Laparoscopic Morcellator Warnings on Uterina Sarcoma Risk

In a move that mirrors a recent decision by U.S. regulators, health officials in Canada indicate that new warnings will be placed on electric morcellators that indicate women may face a risk of spreading unsuspected sarcoma following laparoscopic uterine fibroid removal surgery.

Health Canada announced the new laparoscopic morcellator cancer warnings on December 10, just weeks after the FDA made a similar announcement and required manufacturers to place a new “black box” warning about the risk of morcellation disseminating uterine cancers.

Electric morcellators are medical devices used during laparoscopic hysterectomy and myomectomy procedures, allowing the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The tool facilitates a minimally invasive surgery, which reduces recovery time, minimizes scarring and helps avoid many of the risks associated with traditional surgery.

Over the past year, concerns have emerged over the risks associated with the morcellators, as they may cause unsuspected sarcoma contained within the uterus to be spread throughout the body, rapidly upstaging aggressive uterine cancers.

As a result of estimates that suggest up to one in 350 women undergoing a laparoscopic hyesterecomy or fibroid removal may have this unsuspected uterine cancer, which doctors are unable to detect or diagnose before the procedure, many health experts have called for electric morcellator recalls to be issued.

In a controversial decision, U.S. regulators announced last month that the devices will remain on the market subject to stronger warnings and contraindications that eliminate most uses for morcellators.

The label warning requirements announced by Health Canada are nearly identical those announced by the FDA, indicating that electric morcellation during fibroid surgery may spread undiagnosed cancer cells to other organs and result in decreased odds of long-term survival for the patient.

Health Canada is also contraindicating the devices for removal of uterine tissue that contains suspected fibroids in peri-menopausal and post-menopausal women, as well as candidates for en bloc tissue removal. It also contraindicates their use in gynecological surgery where the tissue to be morcellated is known or suspected to be cancerous.

Those contraindications, if followed by doctors, eliminate most power morcellator uses, health experts say.

Laparoscopic Morcellator Cancer Risks

Concerns about the risk of electric morcellators disseminating uterine cancer have gained widespread attention in the medical community over the past year.

In April 2014, the FDA urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures due to the cancer risks and convened an FDA advisory panel meeting over the summer to evaluate the available data on the safety of the devices.

The panel of independent advisors to the FDA concluded that there was no way to make electric morcellators safer, but was split on whether to recommend a recall or stronger warnings.

In recent months, a growing number of women and families nationwide have been filing laparoscopic morcellator cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.

Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.