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INDICATIONS FOR USE:
GalaFLEX™ 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. GalaFLEX™ 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 INFORMATION:
Possible complications following implantation of the GalaFLEX™, GalaFLEX 3D™, and GalaFLEX 3DR™ Scaffolds include infection, seroma, pain and swelling, scaffold migration, wound dehiscence, haemorrhage, adhesions, haematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, and adverse events, consult the specific GalaFLEX™ Scaffold Product Instructions for Use.
INDICATIONS FOR USE:
GalaFLEX 3D™ 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. GalaFLEX 3D™ 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 INFORMATION:
Possible complications following implantation of the GalaFLEX™, GalaFLEX 3D™, and GalaFLEX 3DR™ Scaffolds include infection, seroma, pain and swelling, scaffold migration, wound dehiscence, haemorrhage, adhesions, haematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, and adverse events, consult the specific GalaFLEX™ Scaffold Product Instructions for Use.
INDICATIONS FOR USE:
GalaFLEX 3DR™ 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. GalaFLEX 3DR™ 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 INFORMATION:
Possible complications following implantation of the GalaFLEX™, GalaFLEX 3D™, and GalaFLEX 3DR™ Scaffolds include infection, seroma, pain and swelling, scaffold migration, wound dehiscence, haemorrhage, adhesions, haematoma, inflammation, extrusion and recurrence of the soft tissue defect. In pre-clinical testing, the GalaFLEX™ Scaffold collection elicited a minimal tissue reaction characteristic of foreign body response to a substance. The tissue reaction resolved as the scaffold was resorbed. For complete prescribing information, including indications for use, warnings and precautions, and adverse events, consult the specific GalaFLEX™ Scaffold Product Instructions for Use.
References:
1. Mallucci P, Bistoni G. Experience and Indications for the Use of the P4HB Scaffold (GalaFLEX) in Aesthetic Breast Surgery: A 100-Case Experience. Aesthet Surg J. 2022;42(12):1394-1405.
2. Adams WP Jr, Baxter R, Glicksman C, Mast BA, Tantillo M, Van Natta BW. The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study. Aesthet Surg J.
2018;38(5):502-518.
3. Nair NM, Mills DC. Poly-4-Hydroxybutyrate (P4HB) Scaffold Internal Support: Preliminary Experience with Direct Implant Opposition During Complex Breast Revisions. Aesthet Surg J. 2019;39(11):1203-1213.
4. GalaFLEX™ Scaffold Instructions for use.