P4HB mesh offers a safer, absorbable alternative to polypropylene, reducing infection risk and chronic complications in ventral hernia repair
Dr. Greg Vigna, hernia mesh attorney, says, “The Phasix mesh is P4HB, and is completely removed by the body over twelve to eighteen months, so chronic complications are reduced to a minimum while synthetic mesh causes lasting chronic inflammation. The properties of this mesh also reduces the risk of infection with an enhanced bodily response that eliminates bacteria that could colonize the mesh. After 18 to 24 months, there is no longer mesh in the body, so chronic mesh infections should not occur.”
What risk factors for polypropylene mesh infection following ventral hernia repair are reported in the article “Optimal management of mesh infection: Evidence and treatment options” published in International Journal of Abdominal Wall and Hernia Surgery?:
“Modifiable risk factors for mesh infections include active smoking, poorly controlled diabetes mellitus, abdominal skin or wound issues, and obesity.
Operative factors that increase the risk of mesh infection include prior hernia repair, enterotomy and contamination of the surgical field.”
Read Dr. Michael R. Arnold's article: https://journals.lww.com/rhaw/fulltext/2018/01020/optimal_management_of_mesh_infection__evidence_and.2.aspx
Dr. Vigna adds, “There is little justification for general surgeons to use polypropylene or other synthetic materials when P4HB mesh offers comparable effectiveness and is naturally removed from the body. Failed ventral hernia repairs can lead to serious infections, extended recovery times, and multiple procedures. The evidence supports P4HB as equally effective and safe.”
What does Dr. Daniel Tran say in “The use of poly-4-hydroxybutyrate (P4HB, Phasix) mesh in ventral hernia repair: A systematic review and meta-analysis” published in Hernia (2024) 28:989-1004?:
“This study aims to investigate the efficacy and safety profile of poly-4-hydroxybutyrate (P4HB) mesh for ventral hernia repair through a systematic review and meta-analysis.
Sub-meta-analysis restricted to studies with follow up > 18 months continues to show low rates of recurrence of 9%.
Our study demonstrates that the use of P4HB mesh is both safe and effective in ventral hernia repairs. When further analyzed past 18 months, the time where P4HB mesh fully resorbs, the rates of hernia recurrence, surgical site infection, and any complications
remain low of upwards of 5 years and comparable to the rates seen in synthetic and biologics in similar patient populations.”
Read Dr. Tran’s article: https://link.springer.com/article/10.1007/s10029-024-02996-z
Complications of abdominal mesh infection include: 1) Chronic pain, 2) Mesh-enteric fistula, 3) Reoccurrence of hernia, 4) Sepsis, and 5) Septic shock. Treatments may include: 1) Local debridement and VAC pack with antibiotics, 2) Partial mesh excision with antibiotics, 3) Complete mesh removal with antibiotics, and 4) abdominal wall reconstruction with or without mesh.
Dr. Vigna is a California and Washington DC lawyer who focuses on serious injuries caused by defective devices, including Bard Hernia Mesh and Covidien Hernia Mesh. He represents individuals harmed by defective hernia mesh and litigates these cases with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas.
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Greg Vigna, MD, JD
Vigna Law Group
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