Patients allege faulty hernia patches caused infections
Published Sunday, January 24, 2010 10:29PM EST
A lawsuit has been filed on behalf of Canadians who received a medical device that was supposed to lead to successful hernia surgery, but that may have severely injured some patients instead.
The device is called the Kugel mesh. It was a patch used to repair the hole in the abdominal wall caused by hernias. Thousands of the patches have been used for hernia surgeries in Canada and most have caused no problems.
But dozens of patients have developed serious complications and are now hoping to sue. What's more, lawyers working on the lawsuit say there could be many more patients suffering as well.
Kristie Pells, 39, is part of the $300-million class action suit. Pells had her first hernia 12 years ago, when she was pregnant with her son. She says the problems reappeared six years ago, when three more abdominal hernias reappeared.
So in 2003, she had surgery that included using a Kugel mesh to reinforce her abdominal wall. The mesh her doctors used had entered the Canadian market in 2002, and was designed to allow hernias to heal as well as to prevent further recurrences.
Pells says she had no problems for five years. But last July, Pells suddenly developed severe abdominal pain.
"It was almost like a burning sensation, which I thought was a little peculiar. And then this hole appeared with fluid coming out," she remembers.
She says the fluid was caused by a life-threatening infection that had developed in her abdomen. Doctors told her the patch and the ring had broken away from her hernia site and cut into her bowels, triggering the infection. At well, she had developed an abscess and intestinal fistulae. Doctors had to remove part of her lower intestine because of the damage, she says.
Now, still trying to recover, Pells says she's angry about what she had to go through.
"Your health is very important and you trust that things put out onto the market will make you better and when it doesn't make you better and it makes you worse, it makes you very angry and upset," she says.
A family friend who was going for hernia surgery herself did some research and noticed that some Kugel mesh patches had been recalled and that lawsuits were brewing in the U.S. That was the first Pells heard about the recall.
She had a lawyer contact her surgeon and found that she had been given one of the Kugel mesh products.
Now, she is one of two lead plaintiffs involved in a class action lawsuit against, collectively, the Kugel patch manufacturer and distributor, Bard Canada; its U.S. parent company C.S. Bard Inc.; and the Bard subsidiary, Davol Inc.
The statement of claim was issued in Ontario Superior Court in May, 2009. The claim alleges the defendants negligently breached their duty of care to patients in the development, testing, manufacture and promotion of their Kugel Mesh products.The claim has not been proven in court.
Some of the patches were ordered off the Canadian market in February, 2006, three years after Pells had her surgery, because of reports the devices were linked to infections, and abdominal damage.
Many people who undergo hernia surgery have had no patches used. Even in those who have had the patches, doctors say that if they've had no health problems, they should not worry.
But lawyer Harvin Pitch from the law firm that's representing Pells, Stevensons LLP, says he believes there are thousands of Canadians who may be having health problems but don't realize they are linked to this now-banned product.
"They know they have bowel or abdominal problems, but may think it's from an operation, or just 'one of those things'," he says.
Pitch says there are now 144 patients involved in this class action but he believes there could be more to come.
At the famed Shouldice Hospital in Toronto, which specializes in hernia surgeries, doctors say they rarely use mesh products, since the majority of hernias can be repaired without them.
"To introduce yourself to a foreign body like mesh, you open yourself up to a whole bunch of complications," says surgeon Dr. Byrnes Shouldice.
Shouldice says surgeons at his clinic are more likely to be asked to repair the damage caused by patches that dislodge and move around
"We are finding more and more reoccurrences coming with mesh, and these cases are more difficult to repair," he says.
Pells has recovered from her colon surgery and is back to work, but says she is in constant pain.
She no longer participates in sports, has her husband lift everything for her, from a pot of water to a bottle of laundry detergent. She is even afraid to go out for a walk in the snow, in case she slips and causes an internal tear.
She wants others to know about the lawsuit so that others like her can be compensated.
Pitch said the hope is to get the lawsuit certified by the end of February and if they can satisfy the court, to have it approved as a class action by fall.
Thousands of patients have filed claims in the U.S. in connection with personal injuries associated with the Kugel mesh. Bard has refuted most of the claims, saying it acted responsibly and began the recall voluntarily as soon as troubles with the patch surfaced.
If you would like more information on the Canadian class-action lawsuit or would like to be included, please contact the lawyers involved, Stevensons LLP, at: Kugel Mesh Class Action Lawsuit in Canada.
With a report from CTV's medical specialist Avis Favaro and producer Elizabeth St. Philip