Dynamesh makers taking a responsible and deliberate path toward acceptance of PVDF as a useful biomaterial for transvaginal treatment of pelvic organ prolapse.
“The makers of Dynamesh (PVDF), in a 2023 study from Taiwan, appear to be taking a responsible and deliberate path towards general acceptance of PVDF as a useful biomaterial for the transvaginal treatment of pelvic organ prolapse” … Greg Vigna, MD, JD, national pharmaceutical injury attorney. (https://www.mdpi.com/2075-4418/13/18/2991)
What did the study show for the treatment of women with anterior/apical vaginal prolapse with a mean follow-up period for those implanted at 3 years? (Modified Vaginal Mesh Procedure with DynaMesh for the Treatment of Anterior/Apical Vaginal Prolapse. Diagnostics 2023, 13(18), 2991).
“PVDF is a biomaterial used nearly everywhere in the world, but not in the U.S. PVDF is available for mid-urethral slings outside the United States and appears to be safer with less pain and erosions.” — Greg Vigna, MD, JD
“Twenty-three patients (85.2%) achieved postoperative anatomic success, while four patients (14.8%) experienced Stage II cystocele. All recurrent cases were asymptomatic.
During outpatient follow-up, one patient (3.7%) was found to have mesh protrusion. No vaginal oozing, pain, or negative impact on intercourse was reported. One patient (3.7%) complained of buttock pain during a visit.
The three-year objective outcome revealed a subjective/objective success rate of 100%/85.2%, respectively.
The recurrent rate was 14.8%, with all cases involving the anterior compartment, or within the hymen, and all were asymptomatic.”
Dr. Vigna continues, “Polyvinylidene fluoride (PVDF) is a biomaterial used nearly everywhere else in the world, but not in the United States. PVDF is available for mid-urethral slings outside the United States and appears to be safer with less pain and erosions. There is no real downside with using PVDF when compared to polypropylene except cost.”
Dr. Vigna concludes, “I expect a second wave of mass marketing will commence for prospective clients injured by polypropylene mid-urethral slings and polypropylene transvaginal mesh devices once PVDF is brought to the United States market and implanters understand the differences between polypropylene and PVDF, as PVDF is ‘known for its stability and non-reactive properties’ compared with polypropylene.”
Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from mid-urethral slings including:
- 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 is a national pharmaceutical injury attorney in Dallas, Texas. The lawyers represent women in courts across the country.
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.
Click for a FREE BOOK on Vaginal Mesh Pain.
Resources:
https://en.dyna-mesh.com
https://repositorio.uchile.cl/bitstream/handle/2250/139184/Comparative-study-of-polyvinylidene-%20uoride.pdf?sequence=1
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/nau.24586
https://www.sciencedirect.com/science/article/pii/S1743919117301280
https://www.mdpi.com/2075-4418/13/18/2991
https://www.mdpi.com/2075-4418/13/18/2991
Greg Vigna, MD, JD
Vigna Law Group
+ +1 800-761-9206
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