Pharmaceutical

Widower driven to call for ban of surgical tool that spread wife’s uterine cancer

morcellator Widower driven to call for ban of surgical tool that spread wifes uterine cancerGeorge Leuzzi says he will do what he can to push for a ban of power morcellation tools used to remove uterine fibroids or perform hysterectomies in an effort to protect women from the aggressive spreading of uterine cancer that took his wife’s life.

Brenda Leuzzi passed away earlier this month, just two years after undergoing laparoscopic surgery using a power morcellator to remove uterine fibroids. Once the removed tissue was examined, doctors discovered that she had a type of uterine cancer known as uterine sarcoma. The surgical tool, which shreds fibroids and in some cases entire uteruses to be removed through a small incision in the abdomen, can spread cancer throughout the abdomen, which in turn lessens the odds of survival.

The Leuzzis have filed a lawsuit in New York federal court against Ethicon, maker of the Morcelex-brand morcellator used on his wife. The lawsuit claims that the company did not adequately test the surgical tool before marketing it.

About a year ago, a physician whose wife had undetected cancer that was worsened by power morcellation launched a grassroots effort to end the procedure for uterine fibroid treatment. In April, the Food and Drug Administration (FDA) issued a safety advisory for doctors to stop using the devices for uterine fibroid treatment. Leading power morcellator maker Johnson & Johnson also announced it would discontinue sales of the surgical tool.

In July, the FDA held hearings on laparoscopic power morcellation for uterine fibroid treatment and again urged doctors not to use the devices for this purpose. The agency also recommended doctors follow up with patients they had performed power morcellation procedures on. Women who had undergone procedures with the surgical tools were also advised to keep regular appointments with their doctors and to seek prompt medical care if they experience any symptoms of uterine cancer, such as unusual bleeding or pelvic pain, or feel a mass in their pelvic region.

George Leuzzi, however, says the agency should have taken its warning one step further and banned power morcellators for uterine fibroid treatment. “I’m very disappointed in the FDA. They should have banned this by now. They’re just stalling and finding some other way to convince themselves it’s OK. If anybody saw Brenda and the way she died, it’s pretty far from OK. I wouldn’t wish it on my worst enemy.”

Source: Democrat & Chronicle