For nearly a year, we have been waiting for the data comparing retropubic slings to transobturator slings.
“We have been waiting for the underlying data for the New England Journal of Medicine, March 31, 2022 article that destroyed the utility of the Altis sling as groin pain was not reduced when compared with full-length mid-urethral slings. We have been waiting nearly a year for the data comparing retropubic slings to transobturator slings. ” remarks Dr. Greg Vigna, national pharmaceutical injury attorney.
Dr. Greg Vigna, national mid-urethral sling attorney states, “The New England Journal of Medicine article by Dr. Abdel-Fattah, Single-Incision Mini-Slings for Stress Urinary Incontinence in Women, shows the Coloplast Altis device is not viable, and there are legitimate questions raised by physicians, including Dr. Cheryl B. Iglesia, Professor Department of Obstetrics and Gynecology at Georgetown University, as to whether these single incision mini-slings should be used in any woman who wants to remain sexually active as dyspareunia is 2.5x greater than full-length mid-urethral slings.”
“We have been waiting for the underlying data for the NEJM 3/31/22 article that destroyed the utility of the Altis sling as groin pain was not reduced when compared with full-length mid-urethral slings” — Greg Vigna, M.D., J.D.
Dr. Vigna continues, “The manufacturers blame the implanting doctors in virtually every case. It is a litigation strategy. Doctors who are sling lovers are going to have to come to grips with the fact that the manufacturers will hang them out to dry in these cases. We are finding that when doctors are sued and see the internal documents they tend to be a bit more forthright in defending themselves when the manufacturers point their fingers directly at them. We are filing cases against these doctors ourselves. At some point they need to stand up for themselves and their patients.
Physicians should know of the unacceptable, foreseeable, and unavoidable risks of the following:
- Pelvic and/or hip adductor myofascial pain acutely after implantation or years later with a properly positioned Altis®/Obtryx/Solyx/TVT-O/Abbrevo sling compared to safer alternative design/procedures including the Burch and autologous sling and safer alternative designs including the polypropylene retropubic sling, a polypropylene retropubic sling with lighter-weight larger pore mesh, a retropubic or transobturator sling made with PVDF, a retropubic mini-sling with PVDF or polypropylene.
- Obturator and/or pudendal neuralgia acutely after implantation or years later with a properly positioned Altis®/Obtryx/Solyx/TVT-O/Abbrevo compared to safer alternative procedures including the Burch, autologous sling and and safer alternative designs including the polypropylene retropubic sling, a polypropylene retropubic sling with lighter-weight larger pore mesh, a retropubic or transobturator sling with PVDF, a retropubic mini-sling with PVDF or polypropylene.
- Risk of dyspareunia acutely after implantation or years later with a properly positioned Altis®/Obtryx/Solyx/TVT-O/Abbrevo compared to safer alternative design/procedures including the Burch, autologous sling and safer alternative designs including the polypropylene retropubic sling, a polypropylene retropubic sling with lighter-weight larger pore mesh, a retropubic or transobturator sling made with PVDF, a retropubic mini-sling with PVDF or polypropylene.”
Dr. Vigna adds, “We know that implanting physicians are freaking out when they see the internal documents of the defense manufacturers as AUGS AND THEIR PHYSICIAN MEMBERS HAVE BEEN DUPED as to the frequency, severity, and duration of risks of serious complications including pain.”
Dr. Vigna RED FLAG WARNING SYMPTOMS of neurological injury or the myofascial pain syndromes including Complex Regional Pain Syndrome from mid-urethral slings include:
- Groin pain
- Hip pain
- Inability to wear tight pants
- Clitoral pain or numbness
- Severe pain that makes vaginal penetration impossible
- Tailbone pain
- Anorectal pain
- Painful bladder
- Pain with sitting
Dr. Vigna concludes, “I am at the point where I am ready to sue physicians who don’t timely diagnose and treat acute injuries that they cause through their implantation of these defective slings. That will be the next shoe to drop on AUGS and the defense manufacturers.”
Learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia. Download a FREE BOOK on Vaginal Mesh Pain and, for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or visit: https://tvm.lifecare123.com/.
For information regarding sling related complications, click here: https://tvm.lifecare123.com/slingebook.html
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by mid-urethral slings including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and complex regional pain syndrome. Ben Martin is a national pharmaceutical injury attorney in Dallas, Texas. The lawyers represent women in courts across the country.
References:
Abdel-Fattah, et al. Single-Incision Mini-Slings for Stress Urinary Incontinence in Women. The New England Journal of Medicine. March 31, 2022.
https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf
https://www.nice.org.uk/guidance/ng123/resources/urinary-incontinence-and-pelvic-organ-prolapse-in-women-management-pdf-66141657205189
https://www.sciencedirect.com/science/article/pii/S2772974522000138
https://cdn.mdedge.com/files/s3fs-public/issues/articles/obgm0340813_evidence_iglesia.pdf
Greg Vigna, MD, JD
Vigna Law Group
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