Mid-urethral slings made from PVDF are still not available in the United States, despite being available across the rest of the world

Polyvinylidene fluoride (PVDF) is known to have better textile and biological properties”… Dr. Ann-Sophia Page, European Journal of Obstetrics & Gynecology and Reproductive Biology, Volume 279, December 2022, pgs. 60-71.

Dr. Greg Vigna, national product liability attorney states, “Currently in the United States, mid-urethral slings made from PVDF are still not available, but PVDF mid-urethral slings are available across the world. I would expect the American Urogynecologic Society (AUGS) to support testing mid-urethral slings made with PVDF versus polypropylene slings.”

Dr. Vigna continues, “Dejene, et al is the largest study to date that showed that 7.9% of women who have undergone a mid-urethral sling implantation for stress urinary incontinence will undergo another surgery to remove or cut the mesh for complications caused by it, and 17.9% of women will undergo another surgical treatment for failed treatment of stress urinary incontinence.”

What did a randomized polypropylene trans obturator sling versus PVDF trans obturator sling show in Dr. Jordi Sabadell’s article “Polypropylene and polyvinylidene fluoride trans obturator slings for the treatment of female stress urinary incontinence: 1-year outcomes from a multicentre randomized trial”. Neurourology and Urodynamics. 2021: 40: 475-482?

“PVDF is available for mid-urethral slings outside the United States and appear to be safer and at least just as effective in the treatment of stress urinary incontinence than the older devices.” — Greg Vigna, MD, JD

“Polypropylene and PVDF slings showed similar high cure or improvement rates (91.0% vs. 95.6%)

A higher incidence of long-term pain events was observed in the polypropylene group.

The study is underpowered to find differences in specific complications owing to the low number of events.”

Dr. Vigna continues, “PVDF is available for mid-urethral slings outside the United States and appear to be safer and at least just as effective in the treatment of stress urinary incontinence than the older devices made from polypropylene with less pain.”

Dr. Vigna concludes, “Dr. Sabadell’s article also revealed that PVDF when compared with polypropylene trans obturator slings have significantly less groin pain. That is very important, and women in the United States should have the opportunity to benefit from PVDF mid-urethral slings if they desire.”

Vigna Law Group is investigating the Red Flag Warning symptoms of neurological injury from mid-urethral slings including:

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. 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 regarding extrapelvic pain syndromes: https://vignalawgroup.com/mid-urethral-sling-pain-syndrome/.

Click here for a FREE BOOK on Vaginal Mesh Pain: https://vignalawgroup.com/publications/.

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.

Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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