A multimillion-dollar lawsuit has been filed by a group of women who say their lives have never been the same since they had a surgical mesh inserted in them to help treat an embarrassing problem.
All the women had the mesh inserted to help relieve their urinary incontinence and a problem with sagging pelvic organs. But now, some are saying they are suffering severe complications from the treatment and say they were never fully warned of the risks.
Carol Kouyoumjian is one of the women involved in the suit. The former nurse had a stubborn case of incontinence. So six years ago, doctors inserted a transvaginal mesh product around her bladder to try to stop the leaking.
It didn't work. What's more, Kouyoumjian says she developed chronic leg pain and lost her nursing job because she could no longer stand for more than a couple hours at a time.
"I woke up from surgery and the pain was absolutely unbelievable," she says. "If the pain scale runs from 1-10, mine was a 12. My legs were literally vibrating."
Kouyoumjian believes the transvaginal mesh is to blame for her ongoing pain six years after her surgery.
Diane McLaughlin also had the mesh implant in 2006. It solved her bladder problem, but she says it also left her with bouts of severe leg pain.
"I never had this before, nothing so bad that you could just sit down and cry. You don't know what is going on with your body," she says.
Both women allege in the lawsuit that neither the product literature, nor their doctors warned them of the possible risks of the procedure.
Transvaginal surgical mesh products (also referred to as pelvic mesh, or pelvic slings) are used to treat two conditions: stress urinary incontinence (SUI), which is the leakage of urine during such activities as coughing, sneezing, laughing, or exercise; and pelvic organ prolapse (POP), which occurs when the tissues that hold pelvic organs such as the uterus in place become weak, so that organs bulge into -- and sometimes past -- the vaginal opening.
Surgery can help tighten the tissue and relieve SUI and POP, but about a decade ago, the mesh products were introduced that promised to improve success rates. They were sold under such names as Gynemesh, Prolene Mesh and Prolift.
Some studies show the implants do help women and relieve symptoms. But other research suggests around 15 per cent suffer serious complications. In 2008 and again in 2010, U.S. authorities and Health Canada issued two warnings, about the risk for complications. They said the complications can include:
- pain during intercourse
- pain during urination
- vaginal and urinary infections
- injuries to the bowel, bladder and vagina
Then, in July, 2011, the U.S. FDA issued a stronger warning about complications.
"The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare," the agency wrote to health care providers.
"Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk."
Lawyer Matthew Baer with Siskinds LLP, the law firm that is representing Canadian clients says the aim of his firm's lawsuit is to prompt better warnings for women considering the mesh.
"One of the key components of the class action, is to make sure there is a proper warning put in place that reflects the magnitude of the risks and the failure rate so that doctors and patients can make informed decisions," he says.
The defendants in the suit include Johnson & Johnson Inc., Ethicon Inc. and Gynacare.
In a statement to Â鶹´«Ã½, Ethicon, a subsidiary of Johnson & Johnson that manufactured the mesh named in the suit, defended its actions.
"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of these products," the company said in a prepared statement.
Meanwhile, both Carol and Diane have been told they have to live with the mesh, and the pain.
"I have been advised not to have it removed because over time, it becomes part of your body and that can cause many complications," says Kouyoumjian.
Canadian women who have had a transvaginal mesh product and want more information on the lawsuit can visit classaction.ca or call Siskinds LLP at 1-800-461-6166.
With a report from CTV medical specialist Avis Favaro and producer Elizabeth St. Philip
