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. 2013 May 28:2013:238067.
doi: 10.1155/2013/238067. Print 2013.

Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair

Corey R Deeken  1 , Brent D Matthews
Affiliations

Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair

Corey R Deeken et al. ISRN Surg. .

Abstract

Purpose. Poly-4-hydroxybutyrate (P4HB) is a naturally derived, absorbable polymer. P4HB has been manufactured into PHASIX Mesh and P4HB Plug designs for soft tissue repair. The objective of this study was to evaluate mechanical strength, resorption properties, and histologic characteristics in a porcine model. Methods. Bilateral defects were created in the abdominal wall of n = 20 Yucatan minipigs and repaired in a bridged fashion with PHASIX Mesh or P4HB Plug fixated with SorbaFix or permanent suture, respectively. Mechanical strength, resorption properties, and histologic characteristics were evaluated at 6, 12, 26, and 52 weeks (n = 5 each). Results. PHASIX Mesh and P4HB Plug repairs exhibited similar burst strength, stiffness, and molecular weight at all time points, with no significant differences detected between the two devices (P > 0.05). PHASIX Mesh and P4HB Plug repairs also demonstrated significantly greater burst strength and stiffness than native abdominal wall at all time points (P < 0.05), and material resorption increased significantly over time (P < 0.001). Inflammatory infiltrates were mononuclear, and both devices exhibited mild to moderate granulation tissue/vascularization. Conclusions. PHASIX Mesh and P4HB Plug demonstrated significant mechanical strength compared to native abdominal wall, despite significant material resorption over time. Histological assessment revealed a comparable mild inflammatory response and mild to moderate granulation tissue/vascularization.

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Figures

Figure 1
Figure 1
(a) PHASIX Mesh comprised of a fully resorbable polymer (poly-4-hydroxybutyrate, P4HB) monofilament knitted into a flat sheet configuration. (b) P4HB Plug comprised of a fully resorbable polymer (poly-4-hydroxybutyrate, P4HB) monofilament preformed into a three-dimensional shape with a fluted outer layer and inner layers or ‘‘petals” attached at the tip.
Figure 2
Figure 2
(a) PHASIX Mesh placed in the preperitoneal plane (bridging the defect) and fixated circumferentially with approximately n = 16 SorbaFix Absorbable Fixation Device constructs. (b) P4HB Plug placed in the preperitoneal plane as an onlay mesh bridging the defect and fixated circumferentially with approximately n = 12 permanent PROLENE (2-0) sutures.
Figure 3
Figure 3
Macroscopic appearance of PHASIX Mesh (right side) and P4HB Plug (left side) at (a) 6 weeks, (b) 12 weeks, (c) 26 weeks, and (d) 52 weeks. An increase in preperitoneal adipose tissue was observed over time, with no evidence of hernia and/or diastasis.
Figure 4
Figure 4
Mechanical properties of the native abdominal wall compared to PHASIX Mesh and P4HB Plug at 6, 12, 26, and 52 weeks: (a) peak load (N) and (b) relative stiffness (N/mm).
Figure 5
Figure 5
Gel permeation chromatography results showing material resorption of PHASIX Mesh and P4HB Plug increasing significantly over time as evidenced by lower molecular weight over time.
See this image and copyright information in PMC

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