Health Canada Warns About Laparoscopic Morcellation Spreading Cancer

Following similar warnings issued in the U.S. late last month, Canadian health officials are warning doctors in that country about the risk of cancer being spread by power morcellators used during laparoscopic hysterectomies or myomectomies to remove uterine fibroid tumors.  

On May 7, Health Canada released a notice to hospitals, warning that laparoscopic morcellators could accidentally spread unsuspected sarcoma throughout a woman’s body cavity. This may take aggressive cancers, such as leiomyosarcoma, from Stage I to Stage IV, potentially cutting years off of a woman’s life.

Electric morcellators are medical devices used in recent years during a number of different uterine fibroid surgical procedures, such as a laparoscopic supracervical hysterectomy, robotic hysterectomty or laparoscopic myomectomy. Morcellation cuts the tissue or uterine fibroid into small pieces that can be removed through a port incision, reducing recovery time and providing a minimally invasive surgery.

On April 17, the FDA issued a similar warning, indicating that about 1 in 352 women undergoing the procedures for presumed benign leiomyoma actually have unsuspected uterine sarcoma and 1 in 498 women have unsuspected uterine leiomyosarcoma. For these women, use of the laparoscopic morcellator may send cancerous tissue throughout the pelvis, bladder and other remote areas of the body.

“Though screening methods exist to detect cervical cancers, there are no reliable ways to detect uterine sarcomas preoperatively,” noted Health Canada in the warning issued this week. “During minimally invasive gynecologic surgery, morcellation in cases of unsuspected uterine sarcoma has been linked with disseminated peritoneal sarcomatosis. Furthermore, electric morcellation and inadvertent spread of uterine sarcoma would likely negatively impact prognosis, lowering the disease-free and overall survival of affected patients.”

Health Canada issued a list of recommendations to doctors similar to those issued by the U.S. The Canadian agency calls for doctors to:

• Recognize the prevalence of undiagnosed uterine cancer in women who are recommended for uterine fibroid removal.
• Consider alternatives to power morcellation for women with symptomatic uterine fibroids or consider the use of closed morcellation involving a surgical bag as a way to reduce the risk of inadvertently spreading cancerous uterine tissue.
• Adequately warn women about the potential risk of spreading undiagnosed cancer with a laparoscopic power morcellation procedure and what health effects could result.

Laparoscopic Morcellation Lawsuits

As more women and families learn that advanced stage leiomyosarcoma diagnosed following uterine fibroid surgery may have been spread by morcellators, a growing number of product liability lawsuits are being filed against the manufacturers of these devices.

According to allegations raised in laparoscopic morcellation cancer lawsuits filed on behalf of women diagnosed with leiomyosarcoma and other uterine cancers, manufacturers knew or should have known about the potential risk yet withheld information from the medical community and failed to make the product as safe as possible.

In response to the FDA warnings, many hospitals have indicated that they will no longer be performing laparoscopic hysterectomy or uterine fibroid removal surgery with morcellators.

The leading manufacturer of electric morcellators was Ethicon, which announced earlier this month that it was halting sales, distribution and promotion of all power morcellators until the FDA and medical communities can determine the correct course of action regarding the devices.

In a safety communication issued last month, the FDA has indicated that it will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the clinical role of laparoscopic morcellators in treatment of uterine fibroids and whether surgical techniques or the use of accessories like tissue collection bags may make the devices safer. The FDA advisory committee will also review whether a “boxed warning” should be placed on all laparoscopic power morcellators regarding the risk of spreading cancer.