On April 17, 2014, the FDA issued a safety communication discouraging physicians from using laparoscopic power morcellation for removing uterine fibroids. Studies and reports have revealed that the procedure creates a slight risk of spreading cancerous tissues beyond the uterus.
Now, Health Canada has issued a similar warning, sending a notice to hospitals about the concerns associated with these electrically powered instruments.
When Uterine Fibroid Surgery Turns Dangerous
Uterine fibroids are tumors that grow in the wall of the uterus. They are usually benign, but rarely can be malignant. Current screening tests, however, cannot accurately detect the cancer.
Many women can get by without surgery, but some have serious symptoms requiring the removal of the fibroids. Modern methods involve laparoscopic techniques, in which the surgeon can go through very small incisions to cut up the fibroids with an electric morcellator and then pull them out. They can also perform a hysterectomy in this way.
There have been reports, however, of some of the cut-up tissues migrating to other areas of the body where, if they are malignant, they can cause serious and sometimes life-threatening cancer diagnoses.
No Screening for Uterine Cancers
On May 7, 2014, Health Canada sent out a notice to hospitals concerning the use of electric morcellators during laparoscopic hysterectomy and myomectomy. They noted that while these morcellators have allowed surgeons to remove large surgical specimens through small incisions, creating benefits like reduced blood loss and faster recovery, they may also potentially spread “unsuspected uterine malignancies.”
According to the notice: “Though screening methods exist to detect cervical cancers, there are no reliable ways to detect uterine sarcomas preoperatively.” Women who have gone through uterine fibroid surgery with a morcellator and were later diagnosed with cancer were surprised for this very reason—currently, there is no way to tell for sure if the uterine fibroids or other uterine tissues may contain cancerous cells.
Unfortunately, prior to the FDA and Health Canada notices, women were never told about this rare, but possible risk. Dr. Amy Reed, an anesthesiologist at Beth Israel Hospital in Boston, went through the surgery thinking it was a routine procedure, and was told a few days later that she had uterine cancer. She and her husband have started a campaign to raise awareness of the issue.
The Risks of a Negative Outcome
Health Canada added that when a morcellator spreads cancerous tissues during a laparoscopic procedure, the patient’s prognosis is much worse than it would have been before the procedure. Cancer contained in the uterus is more treatable than cancer that has spread to other areas of the body.
The FDA recently determined that one in 352 patients will have an unsuspected sarcoma when undergoing hysterectomy or myomectomy for “presumed benign” tumors.
In light of these findings, Health Canada advised physicians to recognize the risk, make the patient aware, consider alternative treatments when warranted, and potentially consider the use of a “closed morcellation” bag, which can catch cut-up tissues, reducing the risk that they will spread.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.