Ontario woman sues over surgery device, alleges it caused cancer to spread
Published Sunday, August 13, 2017 10:18PM EDT
An Ontario woman has become the first to file a lawsuit against the makers of a surgery tool once widely used during minimally invasive hysterectomies, claiming that the device meant to improve her quality of life may have caused her cancer to spread.
Dawn Green underwent a hysterectomy for fibroids in 2010, and says what should have been a routine surgery became a life-changing crisis instead.
Five years after the surgery, Dawn woke up in severe abdominal pain. After conducting several scans, doctors discovered growths in her abdomen -- growths that turned out to be a rare type of cancer called uterine leiomyosarcoma.
The aggressive cancer is usually found in the uterus, but Green's was in her abdomen and was Stage Three.
"(Doctors) said that the life expectancy is typically five years, so that's when it sunk in that, wow, this is really serious," she said.
When Green began to research her cancer, she discovered that several women in the U.S had also had the same cancer diagnosed in their abdomen -- a cancer that can't be cured with chemo or radiation.
And all the women had linked their cancer to the use of a hysterectomy surgical device called a laparoscopic power morcellator.
Morecellators are drill-like devices that can cut up large chunks of tissue, allowing doctors to remove pieces of the uterus or fibroids though small, keyhole incisions, rather than through the large incision used in traditional hysterectomies.
The device helped drive the growth of minimally invasive hysterectomies, which tend to have quicker recoveries, and even allow some people to leave hospital the same day.
But as the use of the devices increased, research began to emerge showing the morcellators could also take small, undetected tumours inside the uterus or a fibroid and "spray" the cancer cells through the abdomen.
Green had surgery to remove the cancer in her abdomen. She also had her ovaries removed so as not to fuel any remaining cancer with hormones. She is now in early menopause at age 40 and must be monitored by doctors in case the tumours return.
"Every three months, I go for scans and that will be the rest of my life, essentially," she said. Her most recent scans show she is in remission.
Still, Green is suing the makers of the device, filing what's believed to be the first lawsuit of its kind in Canada. In the U.S., more than 300 similar suits are underway.
Green's Toronto-based lawyer, Paul Miller, alleges that women were needlessly put at risk of aggressive cancers because of the devices.
"If you go in for a procedure, thinking that this is going to cure your problem, and then you've come out a year or two later, and now you have stage 3 cancer...something has to change. Companies have to be held accountable if they are responsible," he said.
Leeann Noye of Langley B.C. also is at risk, after her minimally invasive hysterectomy in 2014.
Shortly after her surgery doctors discovered a small leiomyosarcoma that was undetected in her uterus -- and that may have been dissected and spread through her abdomen by a morcellator used in her procedure.
Recent scans show no cancer, but the risk is ever-present because the chances of recurrence with this cancer type are so high. A five-years survival rate is only 50 per cent.
"It feels like I am waiting for the bomb to go off," Noye says.
One of the first people to draw attention to the problems with morcellators was U.S. physician Amy Reed, who developed leiomyosarcoma following a hysterectomy and discovered other women with the same cancer.
She called for changes and although the FDA agreed to issue a warning about the devices, they didn't ban them.
Reed, a mother of six, died in May from uterine cancer.
But, the devices remain in use in many hospitals because doctors say the benefits -- such as faster surgery and faster recovery -- outweigh the small risk that the device will spread an undetected sarcoma.
The FDA says the risk of cancer spread is 1 in 350 women. Other research says it's even lower, affecting only 1 in 1,500 to 1 in 2,000 women.
Dr. Sony Singh, a gynecologist and researcher at the Ottawa Hospital, says doctors in Canada established guidelines in 2015.
They say morcellation is discouraged in women in menopause or older, since their cancer risk is higher, and in women with a history of pelvic cancer.
Others are testing alternative approaches -- using morcellators with plastic bags to contain tissue as it is broken up. This is called "contained morcellation." Some break up the uterus and fibroids using just a scalpel to minimize risks.
Whatever technique is used, Dr. Singh says women need to learn their options -- and physicians need to do a proper work up to ensure the women are not at increased risk.
"Morcellation still has a place but we need to make sure we do it in the best way possible...So is morcellation still performed in Canada today? Yes it is. But we hope it's done safer than it was in the past," said Dr. Singh.
"If women don't feel comfortable, we would go with the traditional surgery," despite its longer recovery time and higher risk of complications, he added.
In the U.S., where morcellator use has dropped dramatically since 2014, Dr. Singh says there has been an increase in complications from increased use of traditional hysterectomy surgery.
Still traditional surgery is an option Dawn Green wishes she'd been offered.
"Given what I know about my situation, had my uterus been removed in one piece I would not be going through this."
Noye says she agreed to be interviewed by CTV News because she wants others choosing surgery to have the facts and ask questions.
"I tell them to ask a long list of questions to see how their procedure is completed. It might sound like a small risk, but it is a real risk," she said.
CTV News requested comment from Karl Storz Endocsopy Canada, the maker of the morcellator named in Dawn Green's lawsuit. We did not receive a reply.
With a report from CTV medical specialist Avis Favaro and producer Elizabeth St. Philip