Trial data published in New England Journal of Medicine show that mini-slings don’t reduce risk of groin pain when compared with full-length mid-urethral slings
“I think TOT (transobturator slings) is done. It seems like there is no further reason to pass a sling all the way through the muscles of the inner thigh. It seemed to be that was the cause of pain, and if you stop at the obturator internus membrane and muscle, it seems more of that pain is avoided,” states Catherine Ann Matthews, MD, Wake Forest Baptist Health.
Greg Vigna, MD, JD, national pharmaceutical injury attorney, says, “Simply because the surgical management of complications of a mini-sling are perceived by Dr. Matthews to be easier than management of traditional transobturator sling doesn’t mean that the Altis and Solyx mini-sling are safe. There is no reliable evidence that a mini-sling reduce the long-term risk of life-altering groin and pelvic pain. The data from the SIMS trial by Abdel-Fattah published in the New England Journal of Medicine showed that mini-slings do not reduce the risk of groin pain when compared with full-length mid-urethral slings and carried with it an increased risk of dyspareunia. That is bad news for women. That is bad for women implanted with mini-slings.”
Dr. Cheryl Iglesia, MD, Professor of the Department of Obstetrics and Gynecology at Georgetown University School of Medicine also has concerns with mini-slings based on the finding of the SIMS trail by Abdel-Fattah, “The higher dyspareunia rate in women undergoing single-incision mini-slings deserves further evaluation.”
Dr. Vigna adds, “Dr. Matthews needs to understand that her comment that mini-slings ‘seems’ to avoid pain is not acceptable. There is no reliable basis for that opinion that groin pain is meaningfully reduced long-term by mini-slings as the literature to date hasn’t accounted for the dropout phenomenon that injured women don’t return to the implanting doctors as they seek specialists with the skill, knowledge, experience, and training to confidently remove all the mesh. Dr. Matthews will rarely see the most injured as she admits that she ‘didn’t have full confidence in my competence at getting out’ the mesh from the inner thigh.”
“The polypropylene mesh health crisis continues as the rate of serious complications are increasing at 15-years after implantation due to the defective nature of polypropylene. ” — Greg Vigna, M.D., J.D.
Dr. Vigna continues, “The Long-Term study from the University of North Carolina at 15-years has a cumulative revision rate at 7.9% with over half of these for surgeries for reasons other than erosion into the vagina. The revision rate for reasons other than for vaginal erosion or urinary retention are increasing. This is very bad data and clearly shows that the American Urogynecology Society has been duked by the manufacturers as to the safety of these devices. We have big problems with the number of severely injured women from polypropylene devices now and into the future because most of these injuries occur after two years. Academic physicians in the position of Dr. Matthews need to step up and learn the skills for providing complete mesh removal and teach their fellows.”
Dr. Vigna concludes, “The polypropylene mesh health crisis continues as the rate of serious complications are increasing at 15-years after implantation due to the defective nature of polypropylene. There is a perceived lack of physicians with the skills to confidently provide complete mesh removal which needs to be addressed by AUGS at a national level. There is plenty of blame to go around for all the responsible parties and I will continue to sue the responsible parties.”
Symptoms of neurological injury 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 is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and complex regional pain syndrome. Ben Martin and Laura Baughman are national pharmaceutical injury attorneys in Dallas, Texas.
Learn more about the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia and read a FREE BOOK on Vaginal Mesh Pain.
For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/ and visit https://tvm.lifecare123.com/slingebook.html for information regarding sling related complications.
References:
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.nejm.org/doi/full/10.1056/NEJMoa2111815?af=R&rss=currentIssue
https://www.sciencedirect.com/science/article/abs/pii/S0020729210003863
Dejene, Funk, Pate, Wu. Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence. Female Pelvic Med Reconstru Surg 2022; 28: 188-193.
https://www.urologytimes.com/view/multicenter-trial-to-evaluate-single-incision-slings
Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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