April 17, 2012 ~ CTV National News on Tuesday, April 17, ran a taped story of two women who are involved in a multimillion dollar class action lawsuit in Canada over vaginal mesh. The women are now disabled and unable to work as a result of being implanted with synthetic surgical mesh as a treatment for incontinence.
Carol Kouyoumjian had the Johnson & Johnson mesh made by Ethicon inserted around her bladder to treat incontinence six years ago. Since then she’s developed chronic leg pain she says is a “12” on a ten scale. She can no longer work as a nurse because she can't stand for any period of time.
Diane McLaughlin says the mesh, inserted in 2006, solved her bladder problem but it left her with severe leg pain. Both women say they were never warned about the long-term and debilitating problems either by their doctor or in the product literature.
There has been one warning about transvaginal mesh complications issued by Health Canada, however many doctors remain unaware of the warning. Synthetic meshes to treat pelvic organ prolapse, (POP) and stress urinary incontinence (SUI) are still on the market.
In July 2011, the FDA issued its second, 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."
CTV reports the meshcomplication rate may be 15 percent, however the actual number of complications is unknown because patients are not tracked after surgery. In the states, the FDA database of 'adverse events' is thought to represent about ten percent of actual injuries. Mesh is still in wide use with thousands of implants put into unsuspecting women every year.
Ethicon, the mesh manufacturer and a subsidiary of Johnson & Johnson, told the network:
“We are convinced the evidence will show we acted appropriately and responsibly in the research, development and marketing of these products.”
Both women in the CTV story have been told they will have to live with the mesh and the pain because it has now become part of their body.
The Canadian law firm, Siskinds LLP says they want better warnings for women considering mesh.
The Statement of Claim alleges that Johnson & Johnson failed to adequately warn patients and physicians of the magnitude of the risk of serious side effects when using one of their transvaginal mesh products compared to alternative treatments. Possible side effects include mesh erosion through the vaginal wall, infection, pain, bladder perforation, vaginal scarring, pain during sexual intercourse, and other problems which may lead to a significant decrease in quality of life due to discomfort and pain.
Matthew Baer, a lawyer with Siskinds LLP, describes the purpose of the proceeding as:
"We believe that through this lawsuit Johnson & Johnson will be required to explain to Canadians what it knew about the risks associated with using their transvaginal mesh products and when they first became aware of those risks. In this case, as with all of these types of cases, we are concerned about whether Canadians were adequately warned of the risks associated with using the products in question. These products are alleged to have high failure, injury and complication rates which could result in frequent and often debilitating re-operations and potentially cause severe and irreversible injuries, conditions and damage.”
CTV- Top Story
Health Canada warning, February 4, 2010
“Health Canada is concerned about Canadian and international reports of various intraoperative and postoperative complications associated with the use of these medical devices.”
Canadian News Wire on Transvaginal Mesh Class Action, April 17, 2012