Manufacturers of surgical mesh used to repair pelvic floor disorders are being sued for $1.5 million by a Louisiana woman who claims the medical device is defective. The lawsuit was filed in Federal Court in New Orleans against Johnson & Johnson Inc. and Ethicon Inc.
The woman’s lawsuit claims that Gynecare Prolift Pelvic Floor System, the Gynecare TVT System, the Gynecare TVT Obturator System, the Gynecare TVT Secure System, the Gynecare Prolift Anterior, Posterior, and/or Total Pelvic Floor System, and the Gynecare Prolift + M Pelvic Floor Repair System are defective transvaginal mesh products.
Transvaginal mesh is a type of surgical mesh used to treat pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2007, the plaintiff was implanted with one or more of the above listed products to repair POP. She claims that the products resulted in urinary incontinence, dyspareunia, infection, bleeding, erosion of the mesh that is part of the Gynecare Systems, discharge, scarring and vaginal prolapse.
In July, the Food and Drug Administration (FDA) issued an alert about surgical mesh, stating that complications were “not rare” and that patients who received the mesh, in particular for POP surgery, may be exposed to greater risk with no added benefit. The agency says it has received nearly 4,000 complaints about the mesh since 2005, with the number of complaints more than doubling in the past two years.
The most frequent complications reported include mesh erosion, pain, infection, bleeding, pain during intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems.
The lawsuit is asking for more than $1.5 million in damages for physical pain and suffering, emotional distress, medical expenses, loss of enjoyment of life, inconvenience, disfigurement, interest and court costs.
Source: The Louisiana Record