Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review

Deeken, Corey R.; Chen, David C.; López-Cano, Manuel; Martin, David P.; Badhwar, Amit

doi:10.3389/fsurg.2023.1157661

Cited by 13 publications

(5 citation statements)

References 94 publications

(238 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The P4HB scaffold that is used in this study is not the final, commercial medical device; therefore it is challenging to draw firm conclusions on the cost effects or savings associated with P4HB. However, studies showed that P4HB resulted in improved clinical outcomes with fewer recurrence rates and complications for hernia repair and resulted in cost savings compared with biological tissue-based degradable materials [ 36 , 37 ]. Phasix (P4HB) mesh turned out to be cost-effective in hernia repair in the long term compared with PP.…”

Section: Discussionmentioning

confidence: 99%

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse

Guler,

Kaestner,

Vodegel

et al. 2024

Int Urogynecol J

View full text Add to dashboard Cite

Introduction and hypothesis Fully absorbable implants may be an alternative to permanent meshes in the correction pf pelvic organ prolapse (POP) as they may reduce adverse events by promoting tissue regeneration and collagen metabolism. This study was aimed at evaluating the long-term host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with polypropylene (PP) mesh. Methods Poly-4-hydroxybutyrate scaffold (n = 16) and PP mesh (n = 16) were surgically implanted in the posterior vaginal wall of parous female Dohne Merino sheep. Vaginal explants were evaluated in terms of gross necropsy, host response (immune response, collagen deposition, tissue regeneration), biomechanics, and degradation of P4HB at 12 and 24 months post-implantation. Results Gross necropsy revealed no infection or fluid collection using P4HB or PP. At 12 months, exposures were observed with both P4HB (3 out of 8) and PP (4 out of 8), whereas at 24 months, exposures were observed only with PP (4 out of 8). The tensile stiffness of the P4HB explants was maintained over time despite complete absorption of P4HB. The collagen amount of the vaginal tissue after P4HB implantation increased over time and was significantly higher than PP at 24 months. P4HB scaffolds exhibited significantly lower myofibroblast differentiation than PP meshes at 24 months. Conclusions The P4HB scaffold allowed for gradual load transfer to the vaginal wall and resulted in mechanically self-sufficient tissue. P4HB scaffold had a more favorable host response than PP mesh, with higher collagen content, lower myofibroblastic differentiation, and no exposures at 24 months. P4HB scaffolds have potential as an alternative to permanent implants in treating POP.

show abstract

Section: Discussionmentioning

confidence: 99%

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse

Guler,

Kaestner,

Vodegel

et al. 2024

Int Urogynecol J

View full text Add to dashboard Cite

show abstract

“…Another synthetic polymer relevant for mesh production is poly-4-hydroxybutyrate (P4HB). This material is fully resorbable, degrading into native collagen in 12–18 months while possessing similar strength and flexibility to permanent synthetic polymers [ 64 , 65 ]. These favorable properties allow increased repair strength during tissue remodeling [ 66 ].…”

Section: Materials Commonly Employed In Mesh Fabricationmentioning

confidence: 99%

“…Concerning hernia repair, two mesh configurations have been produced by Bard Davol (Warwick, RI, USA) from P4HB: Phasix TM (bare, macroporous textile) and Phasix™ ST Mesh (combined with a resorbable hydrogel layer) [ 64 ]. As a woven monofilament mesh, P4HB maintains its tensile strength for at least 6 months, which is a long enough period for the wound strength to reach a maximum healing stage before the material loses its integrity [ 67 ].…”

Section: Materials Commonly Employed In Mesh Fabricationmentioning

confidence: 99%

Novel Material Optimization Strategies for Developing Upgraded Abdominal Meshes

Najm,

Niculescu,

Rădulescu

et al. 2023

IJMS

View full text Add to dashboard Cite

Over 20 million hernias are operated on globally per year, with most interventions requiring mesh reinforcement. A wide range of such medical devices are currently available on the market, most fabricated from synthetic polymers. Yet, searching for an ideal mesh is an ongoing process, with continuous efforts directed toward developing upgraded implants by modifying existing products or creating innovative systems from scratch. In this regard, this review presents the most frequently employed polymers for mesh fabrication, outlining the market available products and their relevant characteristics, further focusing on the state-of-the-art mesh approaches. Specifically, we mainly discuss recent studies concerning coating application, nanomaterials addition, stem cell seeding, and 3D printing of custom mesh designs.

show abstract

“…Poly-4-hydroxybutyrate (P4HB) is a biologically produced, fully resorbable synthetic polymer that has been used to construct meshes for hernia repair applications (1)(2)(3). Bench and preclinical studies have established the long-term strength and durability of P4HB, and clinical studies have extended these findings, documenting outcomes comparable to other mesh materials (4).…”

Section: Introductionmentioning

confidence: 99%

“…P4HB mesh has been utilized in a wide variety of patient populations, but a recent scoping review identified a knowledge gap in umbilical and small to medium-sized, routine ventral hernias (4). Permanent synthetic meshes are commonly utilized in these applications (5)(6)(7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

Early wound morbidity and clinical outcomes associated with P4HB mesh compared to permanent synthetic mesh in umbilical and small to medium, routine ventral hernia repairs

Deeken,

Rosen,

Poulose

et al. 2023

Front. Surg.

Self Cite

View full text Add to dashboard Cite

BackgroundPermanent synthetic meshes such as polypropylene (PP) have been utilized for hernia repair for decades, but concerns remain regarding potential long-term, mesh-related complications. A resorbable polymer such as poly-4-hydroxybutyrate (P4HB) represents an alternative with high initial strength, that gradually resorbs, leaving an abdominal wall that is at least as strong as it would be in its native state. We aimed to compare early wound morbidity and clinical outcomes associated with P4HB to traditional, permanent PP in umbilical and small to medium, routine ventral hernias using data from the Abdominal Core Health Quality Collaborative (ACHQC).MethodsInclusion criteria for the umbilical cohort included: all Centers for Disease Control and Prevention (CDC) wound classes, all Ventral Hernia Working Group (VHWG) hernia grades, and hernia defects <3 cm. The small to medium, routine ventral hernia cohort was limited to CDC class I wounds, VHWG hernia grades I and II, and hernia defects <5 cm. The study group was comprised of P4HB meshes; the comparator group was an aggregate of PP meshes. Clinical outcomes were assessed at 30 days.ResultsThere was no significant difference in early wound morbidity, readmission, or reoperation between the P4HB and PP cohorts. A small number of patients experienced SSO, with ≤4% requiring procedural intervention. None of the patients (0% in all cases) experienced skin/soft tissue necrosis, infected seroma, infected hematoma, exposed/contaminated/infected mesh, enterocutaneous fistula, graft failure, or pain requiring intervention at 30-days. However, P4HB was associated with significantly greater operative time, length of stay, and use of myofascial release compared to PP (p < 0.05 in all cases).ConclusionsShort-term clinical outcomes associated with resorbable P4HB mesh are comparable to permanent synthetic PP mesh in umbilical and small to medium, routine ventral hernia repairs, despite significant differences in operative time and length of stay. Longer-term follow-up is needed to expand on the clinical relevance of these short-term findings.

show abstract

Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review

Cited by 13 publications

References 94 publications

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse

Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse

Novel Material Optimization Strategies for Developing Upgraded Abdominal Meshes

Early wound morbidity and clinical outcomes associated with P4HB mesh compared to permanent synthetic mesh in umbilical and small to medium, routine ventral hernia repairs

Contact Info

Product

Resources

About