The use of TVM slings leads to life-altering pain syndromes that make sexual relations impossible, reduces mobility, and causes bowel and bladder dysfunction.
Transvaginal mesh (TVM) polypropylene slings continue to be pushed by the American Urogynecologic Society (AUGS) and American Gynecological & Obstetrical Society (ACOG) as the de facto ‘Gold Standard’ for the treatment of stress urinary incontinence despite the risk of severe, life-altering pain syndromes that make sexual relations impossible, reduces mobility, and causes bowel and bladder dysfunction.
The definition of de facto is ‘whether by right or not.’ Clearly in the case of TVM slings it was a wrong decision for AUGS and ACOG to carelessly buy into the lack of long-term clinical studies as these devices were pushed into the market-place replacing the “Right” Gold Standard which were autologous slings that are made from a patient’s own tissues.
Late complication profiles for retropubic slings and transobturator slings (TOTs) were published well after Ethicon, Coloplast, American Medical Systems, and Boston Scientific had pushed their products into the marketplace, paid for training of physicians, and paid for key opinion leader physicians in AUGS and ACOG to have ‘ghost written’ articles written under their good names.
“Women and doctors clearly have not been warned of the magnitude of risk of retropubic slings as there are many women with catastrophic pain syndromes with neuropathic (nerve related) pain.” – Dr. Greg Vigna
It is now clear as ACOG has written on its website that autologous pubovaginal slings are as effective as synthetic polypropylene slings without all of the serious complications related to polypropylene devices which include dyspareunia (painful sexual function), erosion into the bladder and other organs and structures, and chronic pain. What is clear now is that TOTs compared with retropubic slings have 6x the risk of dyspareunia (18% vs. 3%) and persistent 3x the risk of persistent pain.
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “Women and doctors clearly have not been warned of the magnitude of risk of retropubic slings as there are many women with catastrophic pain syndromes with neuropathic (nerve related) pain from ilioinguinal neuralgia caused by the manufacturer’s blind placement of the arms of the mesh and complications such as reflex sympathetic dystrophy (also referred as complex regional pain syndrome type 1) which oftentimes results.
Dr. Vigna adds, “AUGS and ACOG have failed to require mandatory CME (Continued Medical
Education) on the neurological complications of TOTs and retropubic slings, and those same manufacturers have failed to describe the magnitude of risks for these devices. My team is filing catastrophic injury cases across the country for women who describe crippling pain and severe sexual dysfunction caused by TVM retropubic and TOT slings.”
Greg Vigna, MD, JD is a practicing pharmaceutical injury attorney, California and Washington DC Law Firms, who focuses on catastrophic injuries caused by the TVM devices. His team includes Ben Martin, Esq. and Laura Baughman, Esq. of Martin-Baughman of Dallas Texas, who have decades of product liability experience and catastrophic injury experience. Mr. Martin is Co-Lead counsel of the Cook IVC filter MDL and is representing women who are awaiting remand from the TVM MDL, women with catastrophic injuries from the TVM whose cases have been dismissed without prejudice from the MDL, and is representing new injury cases arising from pelvic organ prolapse devices and slings across the country’s long with local attorneys.
For resources related to pudendal and obturator neuralgia visit: https://tvm.lifecare123.com/pudendal-portal. For a free eBook on Pudendal Neuralgia visit: https://tvm.lifecare123.com/page/e-book.html. For Video Related to Obturator Neuralgia visit: http://hibner.phaktory.net/video/65674772.
Dr. Greg Vigna is a practicing physician, medical expert in Life Care Planning, and a national pharmaceutical injury attorney.