The information on this site is intended for healthcare professionals only. By accepting you confirm you are a healthcare professional. If you are a patient, please click here. The information contained in this website is intended for Health Care Professionals. If you are a patient, please consult with your physician. NOT INTENDED FOR U.S. AUDIENCES.

What is P4HB

Unique features of GalaFLEX™ Scaffold

GalaFLEX™ Scaffold is developed from a unique P4HB polymer.
(poly-4-hydroxybutyrate)

Bioabsorbable

• GalaFLEX™ Scaffold degrades gradually and predictably within 18 to 24 months and is eliminated from the body as water and carbon dioxide through natural physiologic pathways.10-13

Biologically-derived

• P4HB degrades into 4HB—a naturally occurring human metabolite found in the brain, heart, liver, kidney and muscle. 10,14

• Absorption of P4HB naturally initiates an early shift of macrophages from a pro-inflammatory phenotype to a pro-remodeling phenotype. Also known as “repair” macrophages, these pro-remodeling macrophages help to regenerate native tissue.11,15,16

Monofilament

• Reduced risk of infection

• Monofilament materials have been shown to have, on average, 60% less surface area than that of multifilament materials, potentially leading to an improved healing response.10-13,17

• The complex structure of multifilament scaffolds carry the risk of harboring bacteria and could inhibit the natural healing process.17-21

Colonization resistance

• In preclinical studies, P4HB has been shown to demonstrate resistance to bacterial colonization.11,22,23

• P4HB has also been shown to result in the upregulation of antimicrobial peptides (AMPs).11,22,23

Predictable strength

• Provides immediate support at time of surgery and promotes healing and stability due to rapid integration.11-14,24

• At two weeks >75% tissue integration has been demonstrated in preclinical studies.18

• Preclinical studies show that P4HB promotes the production of new collagen and is replaced by patient,s own tissue over time.12,12,24

• Supports the maturation from type III collagen to type I collagen.11,12

• Mature collagen (i.e., Type I collagen) is prevalent at 7 months.11

Long term support

• Leaves behind tissue 3-4x stronger than native tissue12,12,24

• Clinical studies have shown that GalaFLEXTM Scaffold supports and stabilizes the long-term position of the lower pole and inframammary fold (IMF) in breast surgery procedures.25,26,27

Long-term repair strength in a preclinical model11-12-24

stronger than
native tissue28-31

References​:

10. GalaFLEX Scaffold Instructions For Use.
11. Preclinical data on file. Results may not correlate to clinical outcomes.
12. Deeken CR, Matthews BD. 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. ISRN Surg. 2013;2013:238067. Published 2013 May 28. doi:10.1155/2013/238067.
13. Martin DP, Williams SF. Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial. Biochem Eng J. 2003;16(2):97-105.
14. Williams SF, Martin DP, Moses AC. The History of GalaFLEX P4HB Scaffold. Aesthet Surg J. 2016 Nov;36(suppl 2):S33-S42. doi: 10.1093/asj/sjw141.
15. No scaffold is indicated for use in contaminated or infected wounds.
16. Pineda Molina C, Giglio R, Gandhi RM, Sicari BM, Londono R, Hussey GS, et al. Comparison of the host macrophage response to synthetic and biologic surgical meshes used for ventral hernia repair. J Immunol Regen Med. 2019;3:13–25.
17. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen MJ. Voskerician G, Jacobs MR, Rosen MJ. Novel in vitro model for assessing susceptibility of synthetic hernia repair meshes to Staphylococcus aureus infection using green fluorescent protein-labeled bacteria and modern imaging techniques. Surg Infect (Larchmt). 2010;11(5):449-454. doi:10.1089/sur.2009.048.
18. Nguyen, Phuoc T., et al. “Influence of a New Monofilament Polyester Mesh on Inflammation and Matrix Remodeling.” Journal of Investigative Surgery, vol. 25, no. 5, Sept. 2012, pp. 330-339. EBSCOhost, doi:10.3109/089L1939.2011.639848.
19. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. Do multifilament alloplastic meshes increase the infection rate? Analysis of the polymeric surface, the bacteria adherence, and the in vivo consequences in a rat model. J Biomed Mater Res. 2002;63(6):765-771. doi:10.1002/jbm.10449.
20. Engelsman AF, van der Mei HC, Ploeg RJ, Busscher HJ. The phenomenon of infection with abdominal wall reconstruction.” Biomaterials. 2007;28(14), 2314-2327.
21. Thornton, M. Julie. “Estrogens and Aging Skin.” Dermato-Endocrinology, vol. 5, no. 2, 2013, pp. 264–270., doi:10.4161/derm.23872.
22. Pineda Molina C, Hussey GS, Liu A, Eriksson J, D’Angelo WA, Badylak SF. Role of 4-hydroxybutyrate in increased resistance to surgical site infections associated with surgical meshes. Biomaterials. 2021;267:120493.
23. Pineda Molina C, Hussey GS, Eriksson J, et al. L-Hydroxybutyrate Promotes Endogenous Antimicrobial Peptide Expression in Macrophages. Tissue Eng Part A. 2019;25(9-10):693-706. doi:10.1089/ten.TEA.2018.0377.
24. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701.
25. Mallucci P, Bistoni G. Experience and Indications for the Use of the PLHB Scaffold (GalaFLEX) in Aesthetic Breast Surgery: A 100-Case Experience. Aesthet Surg J. 2022;42(12):1394-1405.
26. Adams WP Jr, Baxter R, Glicksman C, Mast BA, Tantillo M, Van Natta BW. The Use of Poly-L-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study. Aesthet Surg J. 2018;38(5):502-518.
27. Bistoni G, Sofo F, Cagli B, Buccheri EM, Mallucci P. Artificial Intelligence, Genuine Outcome: Analysis of 72 Consecutive Cases of Subfascial Augmentation Mastopexy With Smooth Round Implants Supported by P4HB Scaffold. Aesthet Surg J. Published online May 14, 2024.
28. Choi JW, Kwon SH, Huh CH, Park KC, Youn SW. The influences of skin visco-elasticity, hydration level and aging on the formation of wrinkles: a comprehensive and objective approach. Skin Res Technol. 2013;19(1):e349-e355.
29. Vera, Martin. “Phases of Wound Healing: The Breakdown.” Wound Source. Accessed on Nov 13, 2020.
30. Levenson SM, Geever EF, Crowley LV, Oates JF 3rd, Berard CW, Rosen H. The Healing of Rat Skin Wounds. Ann Surg. 1965;161(2):293–308.
31. Engelsman AF, van der Mei HC, Ploeg RJ, Busscher HJ. The phenomenon of infection with abdominal wall reconstruction.” Biomaterials. 2007;28(14), 2314-2327.