“There is a biodegradable mesh approaching the market that is resorbed from the body over two years and replaced by collagen. Not a permanent device because it is 100% degraded and removed from the body. This and other technology should push the defective cash cow polypropylene mid-urethral slings from the market that have injured two generations of women,” states Greg Vigna, MD, JD. National mid-urethral sling attorney.
What is P4HB (Poly-4-hydroxybutyrate)?
Dr. David C. Chen explains what is P4HB in “Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review” published in Frontiers in Surgery. 12 April 2023?
“An implantable fiber or mesh can presently only be achieved by fermentation, and there are currently no chemically synthesized P4HB-based products used in commercial medical products or devices. Rather, P4HB is typically produced through a biologic recombinant fermentation process using Escherichia coli K12.
P4HB is free of the residual metal catalysts that are common in chemically derived polymers.
P4HB is a strong and flexible material, with a tensile strength comparable to permanent synthetic polymers such as polypropylene and ultrahigh molecular weight polyethylene and can be stretched up to 10x~ its initial length prior to failure.”
Is P4HB available today? Not yet.
Dr. Vigna adds, “Early study with P4HB mesh (TephaFlex) when implanted as a retropubic sling revealed cure rates comparable with polypropylene at 12 and 24 months. This is an important first step as this will eliminate erosions after two years and eliminate the need to remove the mesh for pain and eliminate the risk of late-onset fistulas and other serious complications since the device has been naturally removed by the body.”
Read the first retropubic sling study with P4HB: https://www.sciencedirect.com/science/article/pii/S1553465023009718
Dr. Vigna continues, “Thankfully safer alternative designs are approaching the market. To date shamefully the American Urogynecology Society (AUGS) has not used its position to get PVDF on the in the United States despite double blind study that shows erosions and pain are reduced with it when directly compared with polypropylene transobturator slings. PVDF is known to produce less chronic inflammation and doesn’t shrink when compared with the defective polypropylene.”
See transobturator sling PVDF vs. Polyproplene study.
Read our FREE BOOK on Vaginal Mesh Pain.
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 with a Pennsylvania license. The lawyers represent women in courts across the country.
Dr. Vigna RED FLAP WARNING SYMPTOMS of neurological injury or the myofascial pain syndromes including Complex Regional Pain Syndrome from mid-urethral slings include:
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 concludes, “We are investigating the serious pain syndromes and neurological injuries caused by retropubic slings, transobturator slings, and sacrocolpopexy mesh for both product liability claims against the manufacturers and the physicians that implant them. Early pain with these devices cannot be ignored. Serious neurological pain syndromes that are associated with these procedures cannot be ignored by implanting physicians.”
