Mid-Urethral Sling Manufacturers: PVDF and P4HB Safer Materials versus Polypropylene

Dr. Greg Vigna

Mid-urethral sling materials differ in pain outcomes with new alternatives showing safer and more comfortable treatment of female stress urinary incontinence

LOS ANGELES, CA, UNITED STATES, September 12, 2025 /EINPresswire.com/ -- “Polypropylene and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%)… A higher incidence of long-term pain events was observed in the polypropylene group," according to Dr. Jordi Sabadell.

Dr. Greg Vigna, vaginal mesh attorney, states, "Currently in the United States, mid-urethral slings made from PVDF are not available. Sling manufacturers know that they cannot introduce this technology without data from studies, which could potentially highlight the shortcomings of their polypropylene slings."

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

Read Dr. Sabadell’s article: https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/nau.24586

Dr. Vigna adds, "Dr. Sabadell's article also revealed that when compared with polypropylene transobturator slings, PVDF causes significantly less groin pain. There is now a natural material that is completely removed by the body, so patients do not experience any chronic pain from the device.”

What did the study by Dr. Jan-Paul Roovers report in “Safety and Efficacy Report for the Use of Poly-4-Hydroxybutyrate as a Retropubic Mid-Urethral Sling for Stress Urinary Incontinence: A Prospective 24 Months Follow-Up of New Poly-4-Hydroxybutyrate TephaFlex SUI Bioresorbable MUS" published in JMIG, Vol 31, No. 2. February 2024?

“In search of an alternative for polypropylene as material for MUS surgery in women with SUI, we identified P4HB as candidate material based on the degradation profile and in vitro study results. This first clinical study with 17 participants suggests that a MUS procedure with P4HB can be safely performed, based on low SAE (serious adverse events) rates and no material-related AEs (adverse events) within 24 months of follow-up."

Dr. Roovers' article: https://www.sciencedirect.com/science/article/pii/S1553465023009718

Dr. Vigna concludes, “We are examining cases where women suffer acute pain from polypropylene slings caused by the Coloplast Altis and Aris device and Boston Scientific Solyx and Obtryx, who suffer serious and life-altering acute pain. Doctors who fail to remove these devices when there is early pain share in the liability for negligent selection of a bad device and failure to provide complete mesh removal that exacerbates the harm caused by these bad devices."

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, D.C., 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 Law Group is co-counsel and is a national pharmaceutical injury attorney in Dallas, Texas. The lawyers represent women across the country.

Click here for a free book on Vaginal Mesh Pain.

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Greg Vigna, MD, JD
Vigna Law Group
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