English Health Authorities after a lengthy appraisal of the transobturator slings used in the surgical management of SUI wrote damning assessment
English Health Authorities after a lengthy appraisal of the transobturator slings used in the surgical management of stress urinary incontinence wrote their damning assessment: “serious adverse events such as nerve damage, leg pain and mobility issues (are occurring). In addition, a TVT-O is much harder to remove in its entirety than a TVT (retropubic sling).” Their recent guidance states “the TVT-O should not be offered routinely. In the future, we feel the TVT-O should only be used in exceptional circumstances, if at all.”
Greg Vigna, MD, JD, national pharmaceutical injury attorney, practicing physician, and Certified Life Care Planner clarifies, “Transobturator slings can be inside to out technique or outside to in. The Ethicon TVT-O device is implanted via an inside to out procedure and the remaining transobturator slings on the market are outside to in and these devices are referred to as TOT slings. The long-term disabling conditions caused by the TVT-O and the TOT devices are identical and the mini-sling devices that implant into the obturator internus muscle have the same neurological risks to the TOT and TVT-O.”
“As retropubic sling injured women come to my law firm there is little doubt that RETROPUBIC SLINGS AND TRANSOBTURATOR SLINGS WILL BE LITIGATED OFF THE MARKET as these neurological diagnoses come in.” — Dr. Greg Vigna
Dr. Vigna states, “We are in the process of prosecuting obturator neuralgia and pudendal neuralgia cases caused by TOT, TVT-O, and mini-slings that are inserted into the obturator internus. This litigation will go on for the next decade as latent injuries are occurring, sometimes occurring 10 or more years after implantation. My law firm’s efforts with law firms I co-counsel with will result in these devices being removed from the market. They are trash devices, unreasonably dangerous, and have literally destroyed the quality of the lives of a generation of women. These injuries are not rare and are catastrophic. The risks these devices pose far outweigh their utility. Unfortunately, the Multidistrict Litigation failed to fully compensate the most injured plaintiffs and these catastrophic injuries were, mostly, not worked up so the world could see that these devices needed to be removed from the market. My legal teams are doing that now and our hope is that it will be economically not viable for Ethicon, Coloplast, or Boston Scientific to continue to market these devices.”
The Vigna Law Group target include the transobturator slings and mini-slings that insert into the obturator internus muscle on the market include the following:
Ethicon: TVT-O, Abbrevo
Boston Scientific: Obtryx, Solyx
Coloplast: Aris, Altis
Dr. Vigna clarifies, “We are representing women with latent neurological injuries from transobturator slings from device manufacturers who smartly voluntarily removed them from the market or closed their doors, such as AMS and its Monarc sling and the Bard Align TOT device.”
Dr. Vigna concludes, “Unfortunately the studies sponsored by the manufacturers were biased and would not capture the catastrophic neurological pain syndromes for transobturator slings that relate to pudendal neuralgia and obturator neuralgia. As retropubic sling injured women come to my law firm there is now little doubt that RETROPUBIC SLINGS AND TRANSOBTURATOR SLINGS WILL BE LITIGATED OFF THE MARKET as these neurological diagnoses come in. The neurological complications caused by retropubic slings include ilioinguinal neuralgia and Complex Regional Pain Syndrome and these injuries, like pudendal and obturator neuralgia many times require future medical care between 1.2 to 3.0 million dollars over an injured woman’s lifetime. Those costs must be borne by the companies that caused the harm and we will see to it as the neurological diagnoses provide specific causation and allow for testimony that relates to safer alternative designs that are required in a majority of jurisdictions to prosecute a case. These injuries were not captured by the manufacturer’s biased studies and women are finding their way to specialists who have the skill, knowledge, experience, and training to diagnose and treat the neurological injuries.”
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 clients with these diagnoses filed around the country with Martin Baughman, a Dallas Texas firm. Ben Martin and Laura Baughman are national pharmaceutical injury trial attorneys in Dallas, Texas.
Click here for a FREE BOOK on Vaginal Mesh Pain. For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. Click here for information regarding sling related complications.
References: https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
Greg Vigna
Vigna Law Group
+1 800-761-9206
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