Devices such as the Johnson & Johnson’s TVT-O and Prolift device and the Boston Scientific’s Pinnacle Pelvic Floor System and Obtryx device by design unreasonably place the pudendal nerve in peril.  The result of these devices left several thousand catastrophically injured women in need for life time medical services including physical therapy, medication management, pudendal nerve blocks, and other invasive therapies.  Future care cost for pudendal neuralgia following complete mesh removal for those who suffer from chronic pain is an enormous financial burden that will, for the most part, be paid for by government payor sources for the next 3-4 decades.  The result is a huge financial burden on tax payors who fund the Medicare and Medicaid programs that serve the medically indigent women who become disabled from the vaginal mesh debacle.

Dr. Greg Vigna, MD, JD, damages expert, Certified Life Care Planner, and pharmaceutical injury attorney recognizes this as a “unacceptable cost shift from the defendant manufacturers to the tax payors.  These unacceptable costs have become the basis of law suits by State Attorney Generals in California, Washington State, and Mississippi in attempt to recoup the financial harm to the States.”

Dr. Vigna has researched the national cost of care for essential medical and non-medical services required in the management of mesh complications including Complex Regional Pain Syndrome, Pudendal Neuralgia, and Obturator Neuralgia and the cost of necessary care for a 50-year-old woman to their expected life expectancy can be between 1.5-2.5 million dollars.  Dr. Vigna states, “The cost of care being passed to tax payors is staggering.  When you just think about Interstim, an FDA approved treatment for chronic pelvic pain, the trial and implant cost approximately $96,404.00.”

Dr. Vigna goes on, “Compounding this issue has been the unacceptable compensation for catastrophically injured women negotiated by the various settlements that largely left behind those who are most injured.  With every inadequate settlement that is accepted by an injured woman who believe there are no other litigation option for adequate compensation or those who financially have no other choice to accept an inadequate matrix settlement, there is an inadequate amount funded to the required Medicare Set-Aside amount to protect government payor sources going forward.  Essentially, inadequate compensation is pushing the financial burden to tax payors as opposed to the manufacturer’s shareholders.”

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