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More than 400 people have filed a transvaginal mesh lawsuit in New Jersey state court against Ethicon, Inc. and Johnson & Johnson over problems with their Gynecare mesh products used for treatment of pelvic organ prolapse and stress urinary incontinence.
All of the cases involve complaints filed by women who received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon, which is a wholly owned subsidiary of Johnson & Johnson.
The transvaginal mesh products are used reinforce weakened or damaged tissue during surgery to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Pelvic organ prolapse occurs when the pelvic floor tissues that hold organs in place become weakened or stretched, which can occur following childbirth. Female stress urinary incontinence occurs when the muscles that support the bladder and urethra become weakened, and the surgical mesh may be implanted to act as a bladder sling or hammock to reinforce the muscle.
Although the products were marketed as a safe and effective alternative to traditional products and procedures, a number of women allege that Ethicon Gyncare mesh problems caused them to experience pelvic pain, infections, urinary problems, erosion of the mesh and other complications.
All of the Ethicon Gynecare mesh lawsuits filed in New Jersey state court are centralized for pretrial proceedings before Judge Carol E. Higbee in Atlantic County. At the time the cases were centralized in September 2010, about 60 women had filed a lawsuit over Ethicon Gynecare mesh products. However, according to information released by the court this month, there are now at least 402 cases that have been filed
The complaints allege that Johnson & Johnson knew the products were unreasonably dangerous, but continued to manufacture and sell them. The plaintiffs are charging the company with manufacturing a defective product, negligence, failure to warn, strict liability, fraud and other theories.
According to a study published in August 2010 in the Journal of the American College of Obstetricians and Gynecologists, researchers concluded that there was a high rate of vaginal mesh erosion with Gynecare Prolift mesh, while providing no difference in cure rates.
Earlier this month, the FDA issued a warning about the risk of problems from transvaginal mesh when used for pelvic organ prolapse, indicating that the agency was unable to find any significant benefit for the products over other available means of treatment.
Between 2008 and 2010, the FDA has received more than 1,500 reports of problems with Ethicon Gyncare pelvic mesh and other products placed transvaginally to treat pelvic organ prolapse.
In addition to Johnson & Johnson’s Ethicon mesh products, problems have also been associated with transvaginal mesh sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies.