Women implanted with polyproplene experience complications including serious pain syndromes yet women across the world benefit from a polymer called PVDF.
“Women in the USA are getting implanted with 1970 technology polyproplene and are going down like flies with complications caused by chronic inflammatory effects that include serious pain syndromes including pudendal, obturator, ilioinguinal neuralgia as women across the world are benefiting from a polymer called PVDF that has been around for decades. We will get the answers why Ethicon and Boston Scientific have continued to use polypropylene. Surely, the reason wouldn’t be profits?” stated Greg Vigna, MD, JD, national pharmaceutical injury attorney.
Marco Schiffeler, Inhouse Sales Manager for FEG Textiltechnik, says in written correspondence to Dr. Vigna, “We took a commercial decision to not yet register DynaMesh Products in the United States.”
Greg Vigna, MD, JD, mid-urethral sling attorney states, “A generation of women require surgical revision for complications from the current polyproplene slings at a rate of 7.9% at 15 years. This experiment at the hands of Ethicon, Boston Scientific, Coloplast, and the American Urogynecolgy Society (AUGS) must end. PVDF studies to date show that it works for stress urinary incontinence with less inflammation. What is the leadership at AUGS doing? There must be someone there with a spine to standup for the wellbeing of the women they serve. Why is PVDF not in this market when the data and the experience with polypropylene has been a disaster.”
“We will get the answers why Ethicon and Boston Scientific have continued to use polypropylene. Surely, the reason wouldn’t be profits?” — Greg Vigna, M.D., J.D.
Dr. Vigna continues, “We are waiting for a leader in the AUGS field, such as Dr. Howard Goldman at the Cleveland Clinic, to retract the bogus 2014 Position Statement on the safety of mid-urethral slings or at least say that polypropylene retropubic slings are safer when compared with transobturator slings. He has published that chronic refractory neurological symptoms following transobturator slings are caused by ‘inflammation’ and not by direct nerve injury. This at the same time he advertises his unique skills to provide complete mesh removal for women suffering painful complications from transobturator slings. We believe the transobturator sling should have been banned in 2014 as its use has now been essentially eliminated in England. We believe AUGS should support registries as PVDF gets rolled out in the United States. We believe that AUGS needs to write a statement recognizing the errors of the past that will not happen again with PVDF. We believe that AUGS must state that the 7.9% revision rate for polypropylene mid-urethral slings is unacceptable.”
Dr. Vigna adds, “It is like AUGS doesn’t even know what they are citing in their December 2021 Joint Position Statement on Midurethral Slings. The position statement cites the Klinge article (Citation #7) as evidence of safety of polypropylene, when the article is actually about the dangers of heavy-weight, small pore mesh and a proper classification that reflect complications that are occurring with hernia mesh. Do they not know that Klinge published that 94% of hernia mesh that is removed for pain is the current heavy-weight small pore mesh that is being by way of the vaginas of women across the United States. Just a bunch of silly talk. Who is writing this stuff?”
Dr. Vigna concludes, “PVDF to date is not associated with neuralgia. PVDF when compared with polypropylene transobturator slings works and is associated with less pain at one year. It isn’t like the FDA supports the use of polypropylene mid-urethral slings past one year as they recognize that the studies to date are bogus, plagued by dropout and poor study design. I would say the studies to date on mid-urethral slings are as bogus as the leadership at AUGS.”
Vigna Law Group is investigating the Red Flag Warning 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 mid-urethral slings 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. The lawyers represent women in courts across the country.
Learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia. 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/.
For information regarding sling related complications visit https://tvm.lifecare123.com/slingebook.html.
References:
AUGS 2021 Joint Position Statement: https://www.augs.org/assets/1/6/AUGS-SUFU_Joint_Publication.pdf
Citation 7: https://link.springer.com/content/pdf/10.1007/s10029-012-0913-6.pdf?pdf=button%20sticky
https://link.springer.com/chapter/10.1007/978-3-642-11541-7_28
https://www.augs.org/assets/1/6/AUGS-SUFU_MUS_Position_Statement.pdf
https://www.semanticscholar.org/paper/Position-Statement-on-Mesh-Midurethral-Slings-for-Nager-Tulikangas/bc16aa109e172534e51c617e3c9d7d9e146a9766
Dejene, Funk, Pate, Jennifer M. Wu. Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg 2022; 28: 188-193.
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/nau.24586
https://www.auajournals.org/doi/abs/10.1016/j.juro.2016.03.153
https://consultqd.clevelandclinic.org/debilitating-thigh-pain-transobturator-sling-placement-video/
Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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