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A class action lawsuit has been filed in Canada against Johnson & Johnson over problems with its transvaginal mesh products, which have been linked to reports of severe pelvic pain, infection and erosion of the mesh through the vagina.
The transvaginal mesh class action lawsuit was filed on behalf of two Canadian women who suffered severe leg pain after being implanted with surgical mesh made by Johnson & Johnson subsidiaries, Ethicon and Gynecare.
According to allegations raised in the complaint, the manufacturers failed to adequately warn women about the potential side effects of transvaginal mesh, which is used to repair pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
Hundreds of similar vaginal mesh and bladder sling lawsuits are already pending in the United States against Johnson & Johnson and other manufacturers. Although the federal transvaginal mesh cases have been consolidated for pretrial proceedings, as part of an MDL or multidistrict litigation, the lawsuits are not considered a class action lawsuit in the United States.
The Canadian suit was filed on behalf of Carol Kouyomjian and Diane McLaughlin, but the case seeks to attain class action status to represent all women in Canada who have been injured by Ethicon or Gynecare mesh products.
Both women allege that after they received the vaginal mesh in 2006, sold under the Gynemesh, Prolene Mesh and Prolift labels in Canada, they suffered intense pains and have been told that removing the mesh could cause further complications. Kouyoumjian indicates that the problems cost her a nursing job because she could no longer stand for long periods of time due to the intense pain.
In addition to Ethicon/Gynecare mesh lawsuits brought in the United States, similar lawsuits over Bard Avaulta mesh, Boston Scientific mesh and AMS pelvic mesh have been filed in state and federal courts throughout the country in recent years.
Public awareness about the risk of the vaginal mesh problems increased last year, after the FDA issued warnings about an increasing number of adverse event reports associated with the products.
In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.