NEJM article is just another chapter of the ever-growing history of the failure of heavy-weight polypropylene vaginal mesh devices
“The New England Journal of Medicine published that 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,” explains, Greg Vigna, MD, JD.
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “Manufacturers believed that mini-slings were innovative because it would reduce the risk of groin pain when compared to the full-length mid-urethral slings. Unfortunately, the NEJM article is just another chapter of the ever-growing history of the failure of heavy-weight polypropylene vaginal mesh devices by the manufacturers who brought these terrible devices to market. This is yet another disaster for women.”
Dr. Vigna adds, “Soon we will get the opportunity to review the underlying data from the NEJM article. I would expect this data to support the conclusion that transobturator slings were a very bad idea from the start and that mini-slings do little to reduce the risk of long-term pain when compared with full-length transobturator slings.”
“The retropubic slings on the market are made of heavy-weight polypropylene that leads to excessive tissue contraction that causes the same neurological injuries as the transobturator sling when placed” — Greg Vigna, M.D., J.D.
Dr. Vigna concludes, “Unfortunately, the retropubic slings on the market are made of heavy-weight polypropylene that leads to excessive tissue contraction that causes the same neurological injuries as the transobturator sling when placed according to the Instructions for Use. We are investigating cases across the country where the arms of the retropubic slings are found to be lateral to the arcus at explant which is one of several causative factors as to the occurrence of pain with these devices. It is unconceivable how physicians have not been warned of the frequency of a laterally positioned retropubic sling and the literature that supports early and complete removal of the device if acute pain occurs following implant, including the arms.”
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.
Click here for a FREE BOOK on Vaginal Mesh Pain and, for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal. For information regarding sling related complications visit: https://tvm.lifecare123.com/slingebook.html.
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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