The underlying data compared complications of the retropubic slings with transobturator slings and compared the Altis mini-sling to Bard’s mini-sling.
We have been waiting for the underlying data from the New England Journal of Medicine, published on March 31, 2022. The underlying data compared complications of the retropubic slings with transobturator slings and compared groin pain and dyspareunia between the Altis mini-sling to Bard’s mini-sling. There was a 14% risk of groin pain at 3-years and 2.5x dyspareunia risk in the mini-sling group and this data for important to women and for the doctors who choose to use the Altis for their patients.” 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, there are legitimate questions that remain unanswered as to which single incision mini-slings, the Altis or the Bard’s Adjust, was responsible for the 2.5x greater risk of dyspareunia in the mini-sling group than full-length mid-urethral slings”.
“The mini-sling group in Dr. Abdel-Fattah’s widely cited study causes dyspareunia 2.5x more than full-length mid-urethral slings.” — Greg Vigna, MD, JD
Dr. Vigna continues, “The manufacturers blame the implanting doctors in virtually every case for groin pain, when in fact Abdel-Fattah show that mini-slings and full-length mid-urethral slings cause groin pain in approximately 14% of women at three-years.”
Dr. Vigna continues, “The Altis® 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 make this device unacceptable as the Altis can cause groin pain, obturator, pudendal neuralgia acutely after implantation or years later.”.
Dr. Vigna adds, “The mini-sling group in Dr. Abdel-Fattah’s widely cited study causes dyspareunia 2.5x more than full-length mid-urethral slings. The Altis is too short, too stiff, and the polypropylene from the Altis causes chronic inflammation more than PVDF.”
Dr. Vigna RED FLAP WARNING SYMPTOMS of neurological injury or the myofascial pain syndromes including Complex Regional Pain Syndrome from mid-urethral slings include:
1) Groin pain
2) Hip pain
3) Inability to wear tight pants.
4) Clitoral pain or numbness
5) Severe pain that makes vaginal penetration impossible
6) Tailbone pain
7) Anorectal pain
8) Painful bladder
9) Pain with sitting
Dr. Greg Vigna, MD, JD 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.
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Resources:
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.nejm.org/doi/full/10.1056/NEJMoa2111815
https://cdn.mdedge.com/files/s3fs-public/issues/articles/obgm0340813_evidence_iglesia.pdf
Greg Vigna, MD, JD
Vigna Law Group
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