Upcoming
Congresses
May 8-9, 2025
Masterclass with Dr. Wouter Peeters
May 30th, 2025
Masterclass with Dr. Patrick Mallucci
May 19th, 2025
Masterclass with Drs N. Leymarie and JF. Honart
Give your patients the
GalaFLEX™ Scaffold advantage.
Get in touch with us
For inquiries from the rest of Europe, the Middle East, and Africa, please contact us at Isabelle Dracacci or complete the form, and we will reach out to you as soon as possible.
Clinical studies
Long-Term Efficacy and Safety of Poly-4-Hydroxybutyrate (P4HB) Scaffold (GalaFLEX) in Mastopexy for Breast Ptosis: A Prospective Study
Ernesto M Buccheri, Giuseppe Lanzano, Amedeo Villanucci, Patrick Mallucci, Giovanni Bistoni, Moustapha Hamdi
Artificial Intelligence, Genuine Outcome: Analysis of 72 Consecutive Cases of Subfascial Augmentation Mastopexy With Smooth Round Implants Supported by P4HB Scaffold
Giovanni Bistoni, Francesco Sofo,
Barbara Cagli, Ernesto Maria Buccheri, Patrick Mallucci
Synthetic Reabsorbable Mesh (GalaFLEX) as Soft Tissue Adjunct in Breast Augmentation Revision Surgery
Ernesto Maria Buccheri, Amedeo Villanucci, Patrick Mallucci, Giovanni Bistoni,
Roy de Vita
Experience and Indications for the Use of the P4HB Scaffold (GalaFLEX) in Aesthetic Breast Surgery: A 100-Case Experience
Patrick Mallucci, Giovanni Bistoni
The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study
William P Adams Jr, Richard Baxter,
Caroline Glicksman, Bruce A Mast,
Michael Tantillo, Bruce W Van Natta
References:
1.Williams, Simon F., David P. Martin, and Arikha C. Moses. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal 36.Suppl 2 (2016): S33–S42. PMC. Web. 1 June 2017.
2.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.
3.GalaFLEX™ Scaffold Instructions for Use.
4.Preclinical data on file. Results may not correlate to clinical outcomes.
5.No scaffold is indicated for use in contaminated or infected wounds.
6.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.
7.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. doi:10.1007/s00464-016-5057-9.
8.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):765-71.
9.Halaweish, Ihab, et al. “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.” Surgical infections 11.5 (2010): 449-454.
10.Engelsman, A. F., van der Mei, H. C., Ploeg, R. J., & Busscher, H. J. (2007). “The phenomenon of infection with abdominal wall reconstruction.” Biomaterials, 28(14), 2314-2327.
11.Deeken CR, Chen DC, Lopez-Cano M, Martin DP, Badhwar A. Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping review. Front Surg. 2023;10:1157661. Published 2023 Apr 12. doi:10.3389/fsurg.2023.1157661.