PVDF has proven safe and effective especially when compared with polypropylene
“The most appropriate biomaterial is one that simply works with as little inflammatory response as possible. PVDF is superior to polypropylene as it has reduced inflammatory response, less scarring, and superior safety to polypropylene. Does the FDA not trust AUGS to reasonably study the devices that are available most everywhere in the world, except the United States?” states Greg Vigna, MD, JD, national pharmaceutical injury attorney.
Dr. Greg Vigna, mid-urethral sling attorney continues, “It is time that the leadership of the American Urogynecologic Society (AUGS) make a statement to Boston Scientific, Ethicon, and Coloplast that the 25-year experiment on a generation of women has failed given the revision rate for complications caused by polypropylene slings at 7.9% and PVDF has proven safe and effective especially when compared with polypropylene.”
“2023 will be about Polyvinylidene fluoride (PVDF).”— Greg Vigna, M.D., J.D
Dr. Vigna continues, “In 1997, Dr. Iglesia wrote that the ‘Revision and removal rate among 961 synthetic urethral slings was 7.3%’. Today we know the revision rate at 15-years is 7.9%. That is not progress. The acts of Ethicon, Coloplast, and Boston Scientific has been utterly disgraceful. My law firm is filing combination medical malpractice claims across the country against physicians and the defense manufacturers. 2023 will be about PVDF and malpractice across the United States.”
Dr. Vigna states, “2023 will be about Polyvinylidene fluoride (PVDF). We have an idea why this biomaterial is not in the United States – purely about money and has nothing to do about safety. We will not be talking about weight of mesh, pore size, as defense experts have spun the lies that confuse the juries. Polypropylene is not a suitable biomaterial. PVDF studies even with structural designs that have failed previously including a design that resembles the worst device ever designed out of polypropylene… the Prolift.”
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
Click these links to read more information about PVDF:
https://www.club-hernie-mesh.com/img/communications/2015/10.pdf
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/nau.24586
https://www.sciencedirect.com/science/article/pii/S1743919117301280
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 and read FREE BOOK on Vaginal Mesh Pain. 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:
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.
C.B. Iglesia, Fenner, Brubaker. The Use of Mesh in Gynecologic Surgery. Int Urogynecol J (1997) 8: 105-115.
Greg Vigna, MD, JD
Vigna Law Group
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