Synthetic polypropylene mid-urethral slings used in the surgical management of SUI became standard of care … claims as to the safety of devices were false.
Synthetic polypropylene mid-urethral slings used in the surgical management of stress urinary incontinence (SUI) became the de facto standard of care by aggressive marketing by mesh manufacturers. Unfortunately for a generation of women many of the claims as to the safety of these devices were false and misleading.
In May 2016, the California Department of Justice sued Johnson & Johnson alleging that the company had neglected to inform patients and doctors of the potential for severe complications and misrepresented the frequency and severity of risks of their products. On January 30, 2020, Ethicon Inc., Johnson & Johnson’s subsidiary, was ordered to pay $344 million by a California Court for false and deceptive marketing Ethicon engaged in to the detriment of women victims.
After two decades and hundreds of thousands of complications caused by polypropylene transvaginal devices and the largest Multidistrict Litigation in history, the laparoscopic Burch procedure is again the go to procedure for responsible physicians across the country as it offers similar success in the treatment of SUI as polypropylene slings without the added risk of blind placement of the polypropylene sling. Evidence is clear that the Burch procedure, a non-mesh surgical treatment developed in the 1960s, is effective without the catastrophic life-altering pain syndromes known to be caused by retropubic slings and transobturator (TOT) slings.
“A substantial percentage of physicians now understand the risk of synthetic slings as they observe catastrophic injuries in their offices.” — Dr. Greg Vigna
Retropubic synthetic polypropylene slings including Ethicon’s TVT, Coloplast Supris, and Boston Scientific Advantage Fit cause ilioinguinal neuralgia and Complex Regional Pain Syndrome, both of which are catastrophic pain syndromes that interfere with mobility and sexual function. These diagnoses are not associated with the Burch procedure.
Transobturator slings including Ethicon’s TVT-O and Abbrevo, Coloplast Aris, and Boston Scientific’s Obtryx cause obturator neuralgia and pudendal neuralgia which are both catastrophic pain syndromes. Obturator neuralgia interferes with mobility and sexual function and pudendal neuralgia interferes with sexual function, mobility, bowel and bladder function. These diagnoses are not associated with the Burch procedure.
Mini-sling devices that are inserted into the obturator internus muscles by way of a “tissue fixation terminal device” which appears to look much like a harpoon include the Coloplast Altis and the Boston Scientific Solyx. These devices were designed to eliminate the mesh in the thigh required in TOT slings. Unfortunately, these devices are known to cause obturator neuralgia and pudendal neuralgia.
Greg Vigna, MD, JD, national pharmaceutical injury attorney, practicing physician, and Certified Life Care Planner states, “A substantial percentage of physicians now understand the risk of synthetic slings as they observe catastrophic injuries in their offices. The laparoscopic Burch procedure is becoming the go to procedure for the surgical treatment of stress urinary incontinence because of its proven safety. My team will be litigating these cases until the last device is surgically removed.”
Dr. Vigna adds, “Proper physician education of the adverse events associated with medical devices is required by law for the device manufacturers. Despite two decades of serious complications, current warnings provided by manufacturer’s instructions for use remain inadequate for the TOT, retropubic, and mini-slings. We argue that there should be specific naming of the neurological complications associated with each device in the instructions for use as opposed to the generic description of “neuromuscular” injury. Only then will patients be in a position to reasonably know the risks.”
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome. He has filed cases around the country with Martin Baughman, a Dallas Texas firm. Ben Martin and Laura Baughman are national pharmaceutical injury trial attorneys in Dallas, Texas.
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Greg Vigna, MD, JD
Vigna Law Group
1155 Coast Village Rd., Suite 3, Santa Barbara, CA