New England Journal of Medicine published evidence that mini-slings carry at least a 2x risk of dyspareunia when compared with full-length mid-urethral slings
“The New England Journal of Medicine published the best evidence to date that the mini-slings that insert into the obturator internus muscle do not reduce the risk of groin pain and are twice as likely to cause dyspareunia when compared to full-length mid-urethral slings. These devices have little utility, if any,” stated Greg Vigna, MD, JD.
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner continued, “Mini-slings were supposed to reduce the risk of groin pain and that doesn’t happen and at the same time these devices carry at least a two times risk of dyspareunia when compared with full-length mid-urethral slings. The data is very bad for women with these single-incision devices and reflect what we have been seeing from women who have come to my firm.”
Dr. Vigna adds, “This was the largest study done to date and was paid for by England’s National Institute for Health Research and published in the New England Journal of Medicine on March 31, 2022. I don’t see how this data supports the routine use of mini-slings in any clinical situation. We have been filing life-altering pain syndromes caused by Boston Scientific’s Solyx and caused by the Coloplast Altis and have been seeing acute injuries following implantation as well as injuries months and sometimes years later.”
“The data is very bad for women with these single-incision devices and reflect what we have been seeing from women who have come to my firm.” — Greg Vigna
Dr. Vigna continues, “We are awaiting the author’s second publication that will disclose all the data for the women in the TVT (retropubic sling) group, the transobturator sling group, and mini-sling group so we can directly compare the groups for the occurrence rate for complications, pain in groin, dyspareunia, need for surgical revision, and efficacy. We are concerned with the data that has been published as there was substantial dropout from the study at four weeks in the full-length mid-urethral sling group and that this dropout might reflect acutely injured women who go elsewhere for care. It will be interesting to know more about the full-length mid-urethral sling group.”
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
Ben Martin and Laura Baughman are national pharmaceutical injury attorneys in Dallas, Texas. 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.
To learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia click here: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
Read our FREE BOOK on Vaginal Mesh Pain and, for articles, video resources, and information, visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. You can also read information here 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
Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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