Clinical

Use of Poly-4-Hydroxybutyrate Mesh to Optimize Soft-Tissue Support in Mastopexy: A Single-Site Study

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William P. Adams, Jr., M.D. and Arikha C. Moses, Ph.D.

Plastic Reconstruction Surgery 139: 67

January 2017

The ptotic breast is surgically rejuvenated through a mastopexy procedure. Recurrent ptosis or other negative changes to the breast shape are not uncommon following mastopexy, as the tissue laxity and skin quality that contributed to ptosis are not surgically corrected. The purpose of this study was to assess the postsurgical changes in the breasts of patients who underwent a primary mastopexy procedure with soft-tissue reinforcement using a long-term poly-4-hydroxybutyrate resorbable scaffold (i.e., GalaFLEX).

Methods: From July of 2012 to January of 2014, 11 consecutive patients underwent a central mound mastopexy with soft-tissue reinforcement in the lower pole using a poly-4-hydroxybutyrate resorbable scaffold. Patients returned for postoperative follow-up visits that included three-dimensional scans of their breasts at months 1, 3, 6, and 12.

Results: There were no major complications in the study. Changes in the breast shape defined by distances between predefined landmarks between months 1 and 12 ranged from 1.5 to 9.6 percent. Some postoperative breast settlement occurred between months 1 and 3. The mean change in the nipple-to–inframammary fold distance from months 1 to 12 was 8 mm. Lower pole stretch was 5 percent.

Conclusions: Initial findings suggest that central mound mastopexy with soft tissue reinforcement in the lower pole performed on difficult larger breasts yields a relatively stable result for 1 year after surgery. There was no statistically significant change between months 3 and 12 from the sternal notch to lowest point on the breast as determined by established three-dimensional imaging techniques.

Clinical

Clinical Use of GalaFLEX in Facial and Breast Cosmetic Plastic Surgery

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

Aesthetic Surgery Journal Jan / Feb 2017

DOI: 10.1093/asj/sjw142

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.

History

The History of GalaFLEX P4HB Scaffold

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

Aesthetic Surgery Journal Jan / Feb 2017

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.

Clinical

Initial Experience With Biologic Polymer Scaffold (Poly-4-hydroxybuturate) in Complex Abdominal Wall Reconstruction

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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, 2016
DOI: 10.1097/SLA.0000000000001916

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, AfricanAmerican 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, AfricanAmerican 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 postdischarge 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.

Clinical

Reducing Postoperative Abdominal Bulge Following Deep Inferior Epigastric Perforator Flap Breast Reconstruction with Onlay Monofilament Poly-4-Hydroxybutyrate Biosynthetic Mesh

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Blair A. Wormer, MD; Nicholas W. Calvin, MD; Jean-Francois Lefaivre, MD; Jason M. Korn, MD; Edward Teng, MD; Anthony S. Aukskalnis, BA; J. Michael Robinson, MD

Division of Plastic Surgery, Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina

Journal of Reconstructive Microsurgery
September 5, 2016
DOI: 10.1055/s-0036-1586495

Abstract: 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.

Material: P4HB

Poly-4-hydroxybutyrate (P4HB): A new generation of resorbable medical devices for tissue repair and regeneration.

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Simon F. Williams, Said Rizk and David P. Martin   

Biomedical Engineering (Impact Factor: 1.46). 06/2013; 58(5):1-14. DOI: 10.1515/bmt-2013-0009

Abstract:   Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo.  In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation.  Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development. 

Material: P4HB

PHA applications: addressing the price performance issue: I. Tissue engineering.

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Simon F Williams, David P Martin, Daniel M Horowitz, Oliver P Peoples

International Journal of Biological Macromolecules

Received 9 September 1998, Accepted 21 September 1998, Available online 7 June 1999

Abstract: This paper describes the development of medical applications for polyhydroxyalkanoates (PHAs), a class of natural polymers with a wide range of thermoplastic properties. Methods are described for preparing PHAs with high purity, modifying these materials to change their surface and degradation properties, and methods for fabricating them into different forms, including tissue engineering scaffolds. Preliminary reports characterizing their in vivo behavior are given, as well as methods for using the natural polymers in tissue engineering applications.

Material: P4HB

Applications of PHAs in Medicine and Pharmacy.

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Simon F. Williams and David P. Martin.

Biopolymers Online

Published 15 JAN 2005

Abstract: Polyhydroxyalkanoates (PHAs) are a class of naturally occurring polyesters that are produced by a wide variety of different microorganisms (Steinb¸chel,1991). Although they are derived biologically, the structures of these polymers bear a fairly close resemblance to some of the synthetic absorbable polymers currently used in medical applications. Owing to their limited availability, the PHAs have remained largely unexplored, yet these polymers offer an extensive range of properties that extend far beyond those currently offered by their synthetic counter-parts.

Material: P4HB

Medical Applications of Poly-4-Hydroxybutyrate: a strong flexible absorbable biomaterial.

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David P. Martin and Simon F. Williams.

Biochemical Engineering Journal 16 (2003) 97-105

Abstract: Poly-4-hydroxybutyrate (P4HB) is being developed as a new absorbable material for implantable medical applications. P4HB promises to open up new opportunities for the development of medical applications by offering a new set of properties that are not currently available. The absorbable biomaterial is strong yet flexible, and degrades in vivo at least in part by a surface erosion process. While the chemical structure of P4HB is similar to that of current absorbable polyesters used in implantable medical products, P4HB is produced by a fermentation process rather than through a chemical synthesis. P4HB is a thermoplastic material that can be processed using standard plastics processing techniques, such as solution casting or melt extrusion. The strength of P4HB fibers prepared by melt extrusion compare well with that of traditional suturing materials, however, P4HB is typically more flexible. P4HB should find use in a wide variety of medical fields such as cardiovascular, wound healing, orthopedic, drug delivery, and tissue engineering applications. This paper describes some of the basic properties of P4HB and several of its potential applications in medicine.

Clinical

Phasix™ Mesh Fully Resorbable Scaffold for Hernia Repair

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Bard Davol, Value Analysis Committee, Product Information Kit

Available from www.davol.com/value-analysis/

Overview: Hernia Repair is one of the most common procedures performed across the U.S., with over one million patients treated each year. With the many choices for hernia repair mesh and related fixation systems on the market, there can be a great deal of confusion when it comes time to choosing the right partner and the right products. There are a number of guidelines for mesh selection based on patient status, but no manufacturer can make ultimate recommendations for hernia mesh based on specific patient conditions. Only the patient’s surgeon can make those calls. It is Bard’s mission to provide an appropriate selection of hernia repair products to support the surgeon’s decision to choose the right procedure and the right product leading to the right outcome.

Clinical

Biomechanical Properties of Superficial Musculoaponeurotic System Tissue With vs. Without Reinforcement With Poly-4-hydroxybutyric Acid Absorbable Mesh

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Angelos PC, Brennan TE, Toriumi DM.

JAMA Facial Plast Surg. 2014 May-Jun;16(3):199-205. doi: 10.1001/jamafacial.2013.2738.

Abstract: It is unknown whether poly-4-hydroxybutyric acid (P4HB)-reinforced superficial musculoaponeurotic system tissue (SMAS) plication techniques will support SMAS imbrication and plication and potentially improve outcomes in rhytidectomy. Objectives: To evaluate the biomechanical properties (tissue breaking strength, suture tearing force, and stress relaxation) of the SMAS with vs without reinforcement with P4HB absorbable mesh and to correlate these results with potential clinical applications. Design: In a cadaver study at an academic setting, 12 fresh frozen cadaver heads were used. Rhytidectomy incisions were made, and the SMAS was harvested and prepared for strength and stress testing using an Instron device. Outcomes: Tissue breaking strength and suture tearing force were analyzed. Stress relaxation test results were also assessed. The results of the SMAS samples alone were compared with those reinforced with P4HB absorbable mesh. Results: Overall, there were significant differences noted in tissue breaking strength and suture tearing force between the 2 groups. When the SMAS was reinforced with absorbable mesh, significant improvements were observed in tissue breaking strength (P < .001) and suture tearing force (P < .003). In addition, less variability was demonstrated in the maximum tensile load-bearing quality of the SMAS when the repair was reinforced with P4HB. Conclusions and Relevance: Reinforcement with P4HB absorbable mesh improves tissue breaking strength and suture tearing force in cadaveric SMAS. It also reduces the variability in load vs displacement seen among samples tested. These data suggest that P4HB-reinforced SMAS imbrication would support higher loads and provide more consistent, long-lasting SMAS support among patients undergoing rhytidectomy. Further studies are needed to correlate these data with clinical outcomes in rhytidectomy.

Pre-Clinical

Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications

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

Journal of Surgical Research

October 2013 Volume 184, Issue 2, Pages 766–773

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.

Pre-Clinical

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

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Corey R. Deeken and Brent D. Matthews 

Department of Surgery, Section of Minimally Invasive Surgery, Washington University School of Medicine, St. Louis, MO 63110, USA 

ISRN Surgery, Vol. 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. 

Indications for Use

Galatea scaffold is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. Galatea scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. 

Important Safety Considerations

Possible complications following implantation of Galatea scaffold include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffold for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. The safety and effectiveness of Galatea scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffold in pediatric use has not been established. Consult the Galatea scaffold Instructions for Use for complete prescribing information; including its indications for use, warnings and precautions.

The information contained in this website is intended for U.S. Health Care Professionals. Patients, please refer to your physician for more information.