Catalina Pineda Molina, Ross Giglio, Riddhi M. Gandhi, Brian M. Sicaria, Ricardo Londono, George S. Hussey, Joseph G. Bartolacci, Lina M. Quijano Luquea, Madeline C. Cramerm, Jenna L. Dziki, Peter M.Crapo, Stephen F. Badylak
Journal of Immunology and Regenerative Medicine Volume 3, Pages 13-25
Link to Publication: https://www.sciencedirect.com/science/article/abs/pii/S2468498818300192

Abstract

The host innate immune response to a surgical mesh is arguably the most important determinant of tissue remodeling and functional outcome. Macrophage phenotype and the associated secretion of pro-inflammatory or anti-inflammatory cytokines during the first 10–14 days following implantation has been strongly associated with downstream events such as chronic inflammation vs. functional tissue remodeling, respectively, and the associated clinical consequences. A persistent, pro-inflammatory (M1-like) macrophage phenotype is typically associated with fibrosis and scarring. In contrast, an early transition to a regulatory, pro-remodeling (M2-like) macrophage phenotype is predictive of organized, site-appropriate connective tissue deposition. The ratio of M2-like to M1-like macrophages in the early post-implantation period defines the microenvironmental milieu and the associated tissue response. The present study evaluated the early macrophage response to a synthetic nonresorbable (Bard® Mesh), synthetic resorbable (TIGR® Matrix Surgical Mesh and GORE® BIO-A® Tissue Reinforcement), synthetic mesh composed of the naturally occurring molecule 4-hydroxybutyrate, (Phasix™ Mesh), and a biologic surgical mesh composed of dermal extracellular matrix (Strattice™ Reconstructive Tissue Matrix); all of which are used in ventral hernia repair. The spatiotemporal distribution of pro-inflammatory (CD68+CD86+TNF-α+) and pro-remodeling (CD68+CD206+) macrophages, and the remodeling response in terms of vascularization, total number of infiltrating cells, presence of multinucleate giant cells (MNGC), and cell layer thickness around the implanted materials was evaluated at 3, 7, 14, 21, and 35 days post implantation. Results showed an association of the synthetic non-resorbable and resorbable meshes with a robust, pro-inflammatory response within 3 days of implantation, and an increased presence of MNGC around the mesh fibers at longer time points. Phasix™ Mesh was associated with an increased presence of M2-like macrophages immediately adjacent to the mesh fibers at earlier time points, and a favorable tissue remodeling outcome at 35 days. Results of the present study are consistent with the premise that an early shift of M1-like to M2-like macrophages is associated with favorable outcomes, including reduced fibrosis, at later time points.

Authors and Funding

Catalina Pineda Molina was supported by the Colciencias-Fulbright Scholarship and the Tuition Remission Fellowship (TRF) from The Center for Latin American Studies (CLAS) at the University of Pittsburgh. The authors thank Lori Walton from the Histology Center at the McGowan Institute for Regenerative Medicine for histologic section preparation and the center for Biologic Imaging at the University of Pittsburgh for access to imaging facilities. Partial funding of this study was provided by CR Bard, Inc.

Catalina Pineda Molina, George S Hussey, Jonas Eriksson, Michael A Shulock, Laura L Cárdenas Bonilla, Ross M Giglio, Riddhi M Gandhi, Brian M Sicari, Derek Wang, Ricardo Londono, Denver M Faulk, Neill J Turner, Stephen F Badylak
Tissue Engineering: Part A. Vol 25, 9 & 10
Link to Publication: https://pubmed.ncbi.nlm.nih.gov/30982430/

Abstract

This study evaluated the biological activity of hydroxylated derivatives of butyrate as inductors of antimicrobial peptides (AMPs) in murine bone marrow-derived macrophages in vitro. A differential modulation of AMP expression by the hydroxylated derivatives of butyrate is shown. The ability of sodium 4-hydroxybutyrate to upregulate AMP expression through a histone deacetylase inhibitory-independent mechanism, and to promote increased resistance to bacterial contamination in vivo are also shown. The findings provide an alternative for prevention of bacterial contamination of implanted biomaterials. Functionalization of biomaterials with hydroxylated derivatives of butyrate can enhance the endogenous antimicrobial activity of the immune system through increased production of AMPs by host cells, thus providing protection against bacterial contamination.

Impact Statement

This study evaluated the biological activity of hydroxylated derivatives of butyrate as inductors of antimicrobial peptides (AMPs) in murine bone marrow-derived macrophages in vitro. A differential modulation of AMP expression by the hydroxylated derivatives of butyrate is shown. The ability of sodium 4-hydroxybutyrate to upregulate AMP expression through a histone deacetylase inhibitory-independent mechanism, and to promote increased resistance to bacterial contamination in vivo are also shown. The findings provide an alternative for prevention of bacterial contamination of implanted biomaterials. Functionalization of biomaterials with hydroxylated derivatives of butyrate can enhance the endogenous antimicrobial activity of the immune system through increased production of AMPs by host cells, thus providing protection against bacterial contamination.

Authors and Funding

C.P.M. was supported by the Colciencias-Fulbright Scholarship and the Tuition Remission Fellowship (TRF) from The Center for Latin American Studies (CLAS), University of Pittsburgh. The authors thank Lori Walton from the Histology Center at the McGowan Institute for Regenerative Medicine for histological section preparation. Partial funding of this study was provided by Becton, Dickinson and Company/CR Bard, Inc.

Spencer P. Lake, Nathaniel F.N. Stoikes, Amit Badhwar, Corey R. Deeken
Annals of Medicine and Surgery
Link to Publication: https://www.sciencedirect.com/science/article/pii/S2049080119301141?via%3Dihub

Abstract

Hybrid hernia meshes combine biological tissue-derived extracellular matrix with permanent or resorbable synthetic. The objective of this study was to evaluate hybrid meshes (Gore® Synecor, Zenapro™, Ovitex™ 1S Reinforced Bioscaffold Permanent, and Ovitex™ 1S Reinforced Bioscaffold Resorbable) compared to non-hybrid, bioresorbable synthetic mesh (Phasix™ Mesh) in a rabbit bacterial inoculation model.

Methods

Subcutaneous pockets were bilaterally created in male, New Zealand White rabbits (n = 25). Circular meshes (3.8 cm diameter) were implanted and inoculated with 1 × 106 colony forming units (CFU) of clinically-isolated methicillin-resistant Staphylococcus aureus (MRSA). A given animal received a single mesh type. Seven days post-inoculation, animals were euthanized and white material and microbial colonization were assessed by abscess scoring and CFU quantification, respectively. Non-parametric Kruskal-Wallis with Dunn’s post-hoc tests compared results for different meshes.

Results

Phasix™ Mesh and Synecor exhibited significantly lower abscess scores than Zenapro™, Ovitex™ 1S Permanent, and Ovitex™ 1S Resorbable (p < 0.05). All pocket swabs for Zenapro™ and Ovitex™ meshes were positive for MRSA (100%), with 20% of Synecor and 0% Phasix™ Mesh. Microbial colonization was significantly lower for Phasix™ Mesh (0 CFU) relative to Zenapro™ (6.73 × 107 CFU (median)), Ovitex™ 1S Permanent (7.87 × 107 CFU) and Ovitex™ 1S Resorbable (1.45 × 108 CFU), and for Synecor (0 CFU) relative to both Ovitex™ meshes. Phasix™ Mesh was the only device with no detectable abscess or microbial colonization.

Conclusions

Phasix™ Mesh demonstrated no detectable abscess or microbial colonization at 7-days post-implantation and inoculation, in contrast with four hybrid meshes, which all demonstrated colonization in a rabbit bacterial inoculation model.

Authors and Funding

Dr. Stoikes is a consultant for, and Dr. Badhwar is an employee of, C.R. Bard, Inc. Dr. Lake is a consultant for, and Dr. Deeken is the owner of, Covalent Bio, LLC, which received funding from C. R. Bard, Inc. for this project, as well as other, unrelated projects.

N. F. N. Stoikes, J. R. Scott, A. Badhwar, C. R. Deeken, G. R. Voeller
Hernia 21:771–782
Link to Publication: https://link.springer.com/article/10.1007/s10029-017-1638-3

Abstract

The objective was to evaluate the host response, resorption, and strength properties, and to assess the performance in the presence of bacteria for Phasix™ Mesh (Phasix™) and Gore® Bio-A® Tissue Reinforcement (Bio-A®) in preclinical models.

Methods

In a rat model, one mesh (2 × 2 cm) was implanted subcutaneously in n = 60 rats. Animals were euthanized after 2, 4, 8, 12, 16, or 24 weeks (n = 5/mesh/time point), and implant sites were assessed for host inflammatory response and overall fibrotic repair thickness. In a rabbit model, meshes (3.8 cm diameter) were bilaterally implanted in subcutaneous pockets in n = 20 rabbits (n = 10 rabbits/mesh) and inoculated with 108 CFU clinically isolated methicillin-resistant Staphylococcus aureus (MRSA). One mesh type was implanted per animal. Animals were euthanized after 7 days, and implants were assessed for abscess formation, bacterial colonization, and mechanical strength.

Results

In the rat study, Phasix™ and Bio-A® exhibited similar biocompatibility, although Bio-A® demonstrated a significantly greater inflammatory response at 4 weeks compared to Phasix™ (p < 0.01). Morphometric analysis demonstrated rapid resorption of Bio-A® implants with initially thicker repair sites at 2, 4, 8, and 12 weeks (p < 0.0001), which transitioned to significantly thinner sites compared to Phasix™ at 16 and 24 weeks (p < 0.0001). In the rabbit bacterial inoculation study, Phasix™ exhibited significantly lower abscess score (p < 0.001) and bacterial colonization (p < 0.01), with significantly greater mechanical strength than Bio-A® (p < 0.001).

Conclusions

Host response, resorption, repair thickness, strength, and bacterial colonization suggest a more stable and favorable outcome for monofilament, microporous devices such as Phasix™ relative to multifilament, microporous devices such as Bio-A® over time.

Authors and Funding

This study was funded by C. R. Bard, Inc. (Davol), Warwick, RI. Nathaniel F. N. Stoikes, MD, Corey R. Deeken, PhD, and Guy R. Voeller, MD, FACS are consultants for, and Jeffrey R. Scott, PhD and Amit Badhwar, PhD are employees of C. R. Bard, Inc. (Davol), Warwick, RI.

E. Vauclair, M. Bert, O. Facy, N. Cheynel, P. Rat, P. Ortega-Deballon

Journal of Visceral Surgery (2020), JVS-1072 

Background

Incisional hernia is a frequent complication after midline laparotomy. The current standard repair includes the use of a synthetic mesh to prevent recurrence. However, the use of a synthetic mesh in a contaminated field carries a higher risk of mesh infection. In this setting biologic and biosynthetic meshes can be used as they resist to infection, but these are absorbable meshes. This raises the question of the risk of recurrence as the mesh disappears. Phasix® is a biosynthetic mesh getting absorbed in 12—18 months. The aim of this study was to assess the 1-year recurrence rate after abdominal-wall repair with a Phasix® mesh. 

Methods

All patients undergoing ventral hernia repair between 2016 and 2018 at the University Hospital of Dijon using a Phasix® mesh were prospectively included in a database. They were all followed-up with a physical exam and a routine CT scan at one year. All postoperative complications were recorded. 

Results

Twenty-nine patients were included in the study (55.2% women), with a mean BMI of 30,25 kg/m2. Nineteen meshes were sublay and 10 intraperitoneal. Complications at 1 month were mainly mild: Clavien-Dindo I and II (61.1%). No mesh was explanted. There was no chronic infection. The mean length of stay was 11.5 days. The 1-year recurrence rate was 10.3%. Conclusion: Patients having undergone complex ventral hernia repair with a Phasix® mesh have a 1-year recurrence rate of 10.3%. No severe surgical site occurrence was detected. A longer follow-up in a larger number of patients could confirm the place of this mesh in abdominal-wall repair. 

Conclusions

Patients having undergone complex ventral hernia repair with a Phasix® mesh have a 1-year recurrence rate of 10.3%. No severe surgical site occurrence was detected. A longer follow-up in a larger number of patients could confirm the place of this mesh in abdominal-wall repair. 

William P. Adams Jr., MD; Dean M. Toriumi, MD; andBruceW. Van Natta, MD

Abstract

Resolution of ptosis is a key step to the success of many plastic surgery procedures. Ptosis is a manifestation of tissue stretch. Tissue stretch can occur as a result of the natural aging process or health of the patient, or tissue may stretch under added weight or volume, such as when implants are placed. Surgical rejuvenation of ptotic tissues is very effective and results in marked changes in the patient profile yet the tissue that resulted in the need for the procedure first place has not improved and ptosis can recur. Recent developments in long-term resorbable porous materials have provided surgeons with the opportunity to experiment with tissue reinforcement in plastic surgery procedures. These new materials have a low profile, rapid tissue integration, and a long-term strength retention profile. Long-term resorbable scaffolds such as poly-4-hydroxybutyrate (P4HB) natural scaffold (GalaFLEX scaffold, Galatea Surgical, Inc., Lexington, MA) have shown promise for a host of plastic surgery indications. This article presents clinical experience with GalaFLEX for soft tissue reinforcement in three different clinical applications; including the reinforcement of the superficial muscular aponeurotic system (SMAS) in minimally invasive facelift, reinforcement of the skin envelope in mastopexy, and reinforcement of the breast capsule ( pocket) in revisional breast surgery. Soft tissue reinforcement has been shown to provide increased mechanical strength as well as improved maintenance of postoperative results.

Downloaded from http://asj.oxfordjournals.org/ by guest on October 5, 2016

Bradley Calobrace, MD, FACS; Chet Mays, MD ; Ryan Wilson, MD; and Ryan Wermeling, MD

Abstract 

Background: Control of the pocket in revisional breast surgery can be technically challenging and unpredictable. A capsulorrhaphy technique has been utilized in altering capsules in secondary aesthetic breast surgery.

Objectives: The authors sought to determine the effectiveness of popcorn capsulorrhaphy in revisional breast surgery.

Methods: A retrospective chart review of revisional breast cases utilizing popcorn capsulorrhaphy was conducted between September 2015 andAugust 2017. Only aesthetic breast cases were included. Data were collected for 149 patients.

Results: One hundred forty-nine patients representing 266 breasts were operated on. The average patient age was 42 years and the mean body mass index was 24.2 kg/m2. The average time from their original surgery to the popcorn capsulorrhaphy secondary procedure was 9.3 years. Indications for capsulorrhaphy included malposition in 163 breasts (61.3%), implant positioning for breast ptosis in 34 breasts (12.8%), pocket adjustment for implant size change in 49 breasts (18.4%), and postexplantation pocket reduction in 20 breasts (7.5%). Of the 266 implants, 145 (54.5%) were smooth, 101 (38%) textured, and 20 (7.5%) were explanted. The average original implant size was 405 cc and the average size placed at the time of capsulorrhaphy was 422 cc. Two hundred thirty-six (88.7%) were in a submuscular pocket and 30 (11.3%) were subglandular. The total number of complications was 39 (14.7%), and 16 (6%) required some type of operative revision.

Conclusions: Popcorn capsulorrhaphy can provide pocket control and stability with low complication and revision rates. The addition of a mesh or biologic at the time of popcorn capsulorrhaphy can further lower the complication and revision rates.

Downloaded from https://academic.oup.com/asj/advance-article-abstract/doi/10.1093/asj/sjy324/5242120 by ASAPS Member Access, k.crescenzi@galateasurgical.com on 28 January 2019

Richard A. Baxter

Baxter Plastic Surgery PLLC, Mountlake Terrace, WA 98043, USA.

Dr. Richard A. Baxter has a special interest in revision breast surgery, internal bra concepts, and ultrasound in aesthetic medicine. In addition to his busy private plastic surgery practice in the Seattle area, he is engaged in clinical research, figure drawing, and learning Argentine tango.

Abstract

The utility of the internal bra for breast support, reconstruction, and in revision breast surgery has been recognized and various materials have been introduced for this application. As clinical experience has grown and new products have been developed, the roles of these materials are becoming better defined. This paper reviews the use of the internal bra concept to date.

Simon F.Williams, PhD; David P. Martin, PhD; and Arikha C. Moses, PhD

Abstract 

The GalaFLEX Scaffold (Galatea Surgical, Inc., Lexington, MA) for plastic and reconstructive surgery belongs to a new generation of products for soft tissue reinforcement made from poly-4-hydroxybutyrate (P4HB). Other members of this new family of products include MonoMax Suture (Aesculap AG, Tuttlingen, Germany) for soft tissue approximation, BioFiber Scaffold (Tornier, Inc., Edina, MN) for tendon repair, and Phasix Mesh (C.R. Bard, Inc., Murray Hill, NJ) for hernia repair. Each of these fully resorbable products provides prolonged strength retention, typically 50% to 70% strength retention at 12 weeks, and facilitates remodeling in vivo to provide a strong, lasting repair. P4HB belongs to a naturally occurring class of biopolymers and fibers made from it are uniquely strong, flexible, and biocompatible. GalaFLEX Scaffold is comprised of high-strength, resorbable P4HB monofilament fibers. It is a knitted macroporous scaffold intended to elevate, reinforce, and repair soft tissue. The scaffold acts as a lattice for new tissue growth, which is rapidly vascularized and becomes fully integrated with adjacent tissue as the fibers resorb. In this review, we describe the development of P4HB, its production, properties, safety, and biocompatibility of devices made from P4HB. Early clinical results and current clinical applications of products made from P4HB are also discussed. The results of postmarket clinical studies evaluating the GalaFLEX Scaffold in rhytidectomy and cosmetic breast surgery demonstrate that the scaffold can reinforce lifted soft tissue, resulting in persistent surgical results in the face and neck at one year, and provide lower pole stability after breast lift at one year.

Downloaded from http://asj.oxfordjournals.org/ by guest on October 5, 2016

Corey R. Deeken, PhD and Brent D. Matthews, MD Department of Surgery, Section of Minimally Invasive Surgery, Washington University School of Medicine, St. Louis, MO 63110,

USA ISRN Surgery 2013

Abstract

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.

Disclousures

None

David P. Martin, PhD; Amit Badhwar, PhD; Devang V. Shah, PhD; Said Rizik, MS; Stephen N. Eldridge, MS; Darcy H. Gagne, BS; Amit Ganatra, MS; Roger E. Darois, BEng; Simon F. Williams, PhD; Hsin-Chien Tai, PhD; and Jeffrey R. Scott, PhD

Journal of Surgical Research Volume 184, Issue 2, Pages 766-773

October 2013

Abstract

Phasix mesh is a fully resorbable implant for soft tissue reconstruction made from knitted poly-4-hydroxybutyrate monofilament fibers. The objectives of this study were to characterize the in vitro and in vivo mechanical and resorption properties of Phasix mesh over time, and to assess the functional performance in a porcine model of abdominal hernia repair. We evaluated accelerated in vitro degradation of Phasix mesh in 3 mol/L HCl through 120 h incubation. We also evaluated functional performance after repair of a surgically created abdominal hernia defect in a porcine model through 72 wk.

Mechanical and molecular weight (MW) properties were fully characterized in both studies over time. Phasix mesh demonstrated a significant reduction in mechanical strength and MW over 120 h in the accelerated degradation in vitro test. In vivo, the Phasix mesh repair demonstrated 80%, 65%, 58%, 37%, and 18% greater strength, compared with native abdominal wall at 8, 16, 32, and 48 wk post-implantation, respectively, and comparable repair strength at 72 wk post-implantation despite a significant reduction in mesh MW over time.

Conclusions: Both in vitro and in vivo data suggest that Phasix mesh provides a durable scaffold for mechanical reinforcement of soft tissue. Furthermore, a Phasix mesh surgical defect repair in a large animal model demonstrated successful transfer of load bearing from the mesh to the repaired abdominal wall, thereby successfully returning the mechanical properties of repaired host tissue to its native state over an extended time period.

Disclousures

Authors: Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Said Rizk, MS, Amit Ganatra, MS, Jeffrey R. Scott, PhD are employees of Tepha, Inc.

Jeffrey R. Scott, Corey R. Deeken, Robert G. Martindale, Michael J. Rosen

Surgical Endoscopy

September 2016, Volume 30, Issue 9, pp 3691–3701

Full article: https://www.ncbi.nlm.nih.gov/pubmed/27369286

Background

The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair.

Methods

Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point).

Results

Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal–mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal–mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling.

Conclusions

Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.

Disclosures

This study was sponsored by C. R. Bard, Inc. (Davol), Warwick, RI. Drs. Robert Martindale, Corey Deeken, and Michael Rosen are paid consultants for, and Dr. Jeffrey R. Scott is an employee of C. R. Bard, Inc. (Davol).

Blair A. Wormer, Nicholas W. Clavin, Jean-Francois Lefaivre, Jason M. Korn, Edward Teng, Anthony S. Aukskalnis, J. Michael Robinson, J reconstr Microsurg 2017; 33(01): 008-018

Feb 2016

Full article: https://www.ncbi.nlm.nih.gov/pubmed/?term=wormer+diep

Abstract

Background The purpose of this study was to evaluate the use of a biosynthetic mesh onlay on reducing postoperative abdominal bulge following deep inferior epigastric perforator (DIEP) flap breast reconstruction.

Methods All patients undergoing DIEP reconstructions from January, 2010 to January, 2014 at a tertiary center were reviewed. Patients were divided into two groups for comparison based on whether a biosynthetic mesh onlay (Phasix [monofilament poly-4-hydroxybutyrate], Bard Inc., Warwick, RI) was used for reinforcement of the anterior rectus fascia. Rates of postoperative abdominal bulge were compared between the groups utilizing standard statistical methods.

Results During the study period, 319 patients underwent 553 DIEP reconstructions, 160 (50.2%) used mesh and 159 (49.8%) did not (nonmesh). The mean follow-up was 16.4 ± 11.1 months. There was no difference in age (49 ± 9.3 years), current tobacco use, diabetes, or mean body mass index (BMI, 29.4 ± 4.4) between the mesh and nonmesh groups (p > 0.05); however, there was a higher proportion of obese patients (BMI > 30) in the mesh group (45.0 vs. 33.3%; p = 0.03). Abdominal bulge rate following DIEP with mesh was lower than the nonmesh group (0 vs. 5.0%; p = 0.004). In the entire sample, 234 (73.4%) underwent bilateral DIEP and 85 (26.6%) underwent unilateral DIEP. In unilateral DIEP patients, the bulge rate was similar between the mesh and nonmesh groups (0 vs. 4.4%; p > 0.05); however, in bilateral DIEP patients, the bulge rate was lower in the mesh group compared with a nonmesh group (0 vs. 5.5%; p = 0.008).

Conclusion Reinforcement of the anterior rectus with an onlay monofilament poly-4-hydroxybutyrate biosynthetic mesh may reduce the risk of postoperative bulge rate in patients undergoing DIEP reconstruction.

Joseph F. Buell, MD, MBA, FACS; David Sigmon, MD; Christopher Ducoin, MD; Max Shapiro, MD; Nikhil Teja, MD; Emmett Wynter, BS; Mary K. Hanisee, MD; Geoffrey Parker, PhD; Emad Kandil, MD, MBA; and Michael Darden, PhD

Annals of Surgery 266(1):185-188

July 2017

Abstract

Objective: To evaluate the use of the new absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) in complex abdominal wall reconstruction.

Background: Complex abdominal wall reconstruction has witnessed tremendous success in the last decade after the introduction of cadaveric biologic scaffolds. However, the use of cadaveric biologic mesh has been expensive and plagued by complications such as seroma, infection, and recurrent hernia. Despite widespread application of cadaveric biologic mesh, little data exist on the superiority of these materials in the setting of high-risk wounds in patients. P4HB, an absorbable polymer scaffold, may present a new alternative to these cadaveric biologic grafts.

Methods: A retrospective analysis of our initial experience with the absorbable polymer scaffold P4HB compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our analysis was performed using SAS 9.3 and Stata 12.

Results: The P4HBgroup (n¼31) experienced shorter drain time(10.0 vs 14.3 d; P < 0.002), fewer complications (22.6% vs 40.5%; P < 0.046), and reherniation (6.5% vs 23.8%; P < 0.049) than the porcine cadaveric mesh group (n¼ 42). Multivariate analysis for infection identified: porcine cadaveric mesh odds ratio 2.82, length of stay odds ratio 1.11; complications: drinker odds ratio 6.52, porcine cadaveric mesh odds ratio 4.03, African American odds ratio 3.08, length of stay odds ratio 1.11; and hernia recurrence: porcine cadaveric mesh odds ratio 5.18, drinker odds ratio 3.62, African American odds ratio 0.24. Cost analysis identified that P4HB had a $7328.91 financial advantage in initial hospitalization and $2241.17 in the 90-day post discharge global period resulting in $9570.07 per case advantage over porcine cadaveric mesh.

Conclusions: In our early clinical experience with the absorbable polymer matrix scaffold P4HB, it seemed to provide superior clinical performance and value-based benefit compared with porcine cadaveric biologic mesh.

Disclousures

None

Margaret A. Plymale, Daniel L. Davenport, Adam Dugan, Amanda Zachem, John Scott Roth

Surgical Endoscopy

April 2018, Volume 32, Issue 4, pp 1689–1694

Full article: https://www.ncbi.nlm.nih.gov/pubmed/28916979

Abstract

Background:

Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh.

Methots:

An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively.

Results:

31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m², and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05).

Conclusions:

Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).

Disclosures

Dr. Roth is a speaker for Bard, has grants with Bard, Life Cell, Gore, and MTF, and is a consultant for Life Cell. Dr. Plymale, Dr. Davenport, Mr. Dugan, Ms. Zachem and Dr. Roth have no conflict of interest or financial ties to disclose.

John Scott Roth, Gary J. Anthone, Don J. Selzer, Benjamin K. Poulose, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, John. R. Romanelli, Gregory J. Mancini, Jacob A. Greenberg, John G. Linn, Eduardo Parra-Davila

Surgical Endoscopy Volume 32, Issue 4, pp 1929–1936

April 2018

Full article : https://www.ncbi.nlm.nih.gov/pubmed/29063307

Abstract

Background:

Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.

Methods:

This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm², ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m²), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing.

Results:

One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m² (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm² (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively.

Conclusions:

High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

This study was sponsored by C. R. Bard, Inc. (Davol), Warwick, RI.

Disclosures

Authors were reimbursed for expenses related to the conduct of the study. JSR, GJA, JGB, WWH, RGM, MIG, DBE, GJM, JAG, EPD, BJS, CRD, and GRV are paid consultants for C. R. Bard, Inc. (Davol). Poulose conflicts: Bard-Davol-research (pertains to this study); Americas Hernia Society Quality Collaborative-compensation; Ariste Medical-consulting; Pfizer-consulting. Deeken conflicts: Covalent Bio, LLC – Owner and Principal Consultant; Biom’Up – consulting; Colorado Therapeutics – consulting; C. R. Bard/Davol, Inc. – consulting (pertains to this study); Musculoskeletal Transplant Foundation – paid Grant reviewer; Johnson & Johnson Medical GmbH – consulting; TELA Bio, Inc. – consulting.

Walaa F. Abdelmoaty, Christy M. Dunst, Filippo Filicori, Ahmed M. Zihni, Daniel Davila-Bradley, Kevin M. Reavis. Lee L. Swanstrom, Steven R. DeMeester. J Gastrointest Surg. 2019 Aug 29.

doi: 10.1007/s11605-019-04358-y

Abstract

Introduction

Laparoscopic paraesophageal hernia (PEH) is associated with a low morbidity and mortality but an objective hernia recurrence rate in excess of 50% at 5 years. Biologic mesh has not been shown to reduce hernia recurrence rates. Recently, a new bioresorbable mesh made with poly-4-hydroxybutyrate with a Sepra-Technology coating on one side (Phasix-ST mesh) has become available. The aim of this study was to evaluate the feasibility, safety, and short-term efficacy of Phasix-ST mesh for reinforcement of the primary crural closure in patients undergoing elective, laparoscopic PEH repair.

Methods

A prospective database was initiated and maintained for all patients undergoing PEH repair with the use of Phasix-ST mesh. We retrospectively reviewed the records of consecutive patients who had an elective, first-time laparoscopic PEH repair with Phasix-ST mesh and who completed their 1-year objective follow-up study. Patients having a reoperation, non-laparoscopic repair, or who failed to comply with the objective follow-up were excluded.

Results

To achieve the desired 50 patients with 1-year objective follow-up, we reviewed the records of 90 consecutive PEH patients. In the final cohort of 50 patients, there were 32 females (64%) and 18 males. The median age of the patients at surgery was 67 years (range 44–84). The operation was PEH repair with fundoplication alone in 29 patients (58%) and PEH repair with Collis gastroplasty and fundoplication in 21 patients (42%). Phasix-ST mesh was used for crural reinforcement in all patients, and there were no intraoperative issues with the mesh or any difficulty placing or fixating the mesh at the hiatus. A diaphragm relaxing incision was performed in 2 patients (4%). The mean length of hospital stay was 2.8 days, and there was no major morbidity or mortality. On the 1-year objective follow-up study (median 12 months) a recurrent hernia was found in 4 patients (8%). No patient that had a Collis gastroplasty or a relaxing incision had a recurrent hernia. No patient had a reoperation. No patient had a mesh infection or mesh erosion.

Conclusions

Phasix-ST mesh reinforcement of the crural closure during laparoscopic primary, elective PEH repair was associated with no adverse mesh-related events such as infection or erosion. Phasix-ST crural reinforcement in combination with tension-reduction techniques when necessary resulted in a very low (8%) objective hernia recurrence rate at a median follow-up of 1 year. These results demonstrate the safety of Phasix-ST mesh for use at the hiatus for crural reinforcement. This safety, along with the encouraging short-term efficacy for reducing hernia recurrence, should encourage further studies using the combination of resorbable biosynthetic mesh crural reinforcement and tension-reducing techniques during repair of paraesophageal hernias.

Funding information

This study was funded by a research grant from Bard/Davol.

Disclaimer

Oversight of the study, data collection, data analysis, and manuscript preparation were under the direction of Steven R. DeMeester independent of Bard/Davol.

Deborah Yu MD, Anika T. Patel, Kristie Rossi BA, Neil S. Topham MD, Eric I. Chang MD

Microsurgery.doi: 10.1002/micr.30541.

First published: 09 December 2019

Full article: https://www.ncbi.nlm.nih.gov/pubmed/31815314

Abstract

Background:

Abdominal free flap harvest for breast reconstruction may result in significant morbidity in terms of hernias and bulges. Reinforcement of the donor site with mesh has been recommended to minimize the risk of hernias and bulges, but no studies exist evaluating the optimal type of mesh. Polypropylene has traditionally been used but the development of Phasix restorable mesh may be a reasonable alternative. Here, we compared the use of Phasix to polypropylene and primary closure and hypothesize that the former has lower rates of abdominal morbidity in the long term.

Patients and Methods:

A retrospective review of all patients undergoing bilateral free flap breast reconstruction from the abdomen was performed while patients with pedicle flaps or alternative donor sites were excluded. Patient demographics, medical/surgical history, cancer treatments, and flap type were analyzed. All patients were monitored for a minimum of 2 years for early donor site complications as well as hernia/bulges.

Results:

Sixty-six consecutive patients were included (40 patients with Phasix, 20 patients with polypropylene, and 6 patients with primary closure). Use of Phasix mesh resulted in higher initial operative costs ($2,750 vs. $72 vs. $0). Two patients with polypropylene mesh and one patient undergoing primary closure developed an abdominal bulge in an average follow-up of 25.2 months (11.5% vs. 0%, p = .04).

Conclusions: 

Mesh placement for abdominal wall reinforcement after bilateral free flap breast reconstruction minimizes the risk of hernias and bulges. Although Phasix results in increased initial costs, abdominal morbidity is significantly decreased after follow-up beyond 2 years.