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If you are a patient, please consult with your physician. NOT INTENDED FOR U.S. AUDIENCES.
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GalaFLEX™ Scaffold Collection
GalaFLEX™ Scaffold
Portfolio sizes
Available in four select sizes to meet various patient needs.
The GalaFLEX™ Scaffold is a biologically-derived 2D scaffold for plastic and reconstructive surgery designed to provide immediate soft tissue reinforcement and a foundation for long-term strength.¹⁻⁵
Indication for use
GalaFLEX™ Scaffold is intended for use, as an adjunct to sutures, for the reinforcement and repair of soft tissue where weakness exists and where the addition of a reinforcing material is needed to obtain the desired surgical result in patients undergoing breast surgery.
GalaFLEX™ Scaffold is designed to be used in patients undergoing soft tissue repair and reinforcement in medically necessary breast surgery procedures where the existing soft tissue is deficient to support the surgical repair. Examples of such breast surgery applications include reduction mammoplasty and breast revision surgery to correct a medical condition. The GalaFLEX™ Scaffold may also be used in cosmetic breast procedures.
Important safety information
Possible complications following implantation of GalaFLEX™ Scaffold includes 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
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Preclinical data on file. Results may not correlate to clinical outcomes.
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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
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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
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Martin DP, Badhwar A, Shah DV, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766-773. doi:10.1016/j.jss.2013.03.044
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GalaFLEX™ Scaffold Instructions for use.
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Based on surgeon feedback.
GalaFLEX 3D™ Scaffold
Robust portfolio of shapes and sizes
Offered in 3D shapes and sizes designed to fit and elevate the body's natural shape.
GalaFLEX 3D™ Scaffold is the first and only formed absorbable scaffold designed to fit and elevate the body's natural shape, providing easier placement and potentially reduced procedure time.¹'³
Indication for use
GalaFLEX 3D™ Scaffold is intended for use, as an adjunct to sutures, for the reinforcement and repair of soft tissue where weakness exists and where the addition of a reinforcing material is needed to obtain the desired surgical result in patients undergoing breast surgery.
GalaFLEX 3D™ Scaffold is designed to be used in patients undergoing soft tissue repair and reinforcement in medically necessary breast surgery procedures where the existing soft tissue is deficient to support the surgical repair. Examples of such breast surgery applications include reduction mammoplasty and breast revision surgery to correct a medical condition. The GalaFLEX 3D™ Scaffold may also be used in cosmetic breast procedures.
Important safety information
Possible complications following implantation of GalaFLEX 3D™ Scaffold includes 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
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Preclinical data on file. Results may not correlate to clinical performance in humans.
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GalaFLEX 3D™ Instructions for Use.
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Based on surgeon feedback.
GalaFLEX 3DR™ Scaffold
Portfolio of sizes
Offered in multiple 3D sizes designed to fit and elevate the body’s natural shape.
GalaFLEX 3DR™ Scaffold is the only 3-dimensional scaffold with a reinforcing rim to ease scaffold placement, allowing for potentially reduced procedure time and support by conforming to the patient’s natural shape.¹'³
Indication for use
GalaFLEX 3DR™ Scaffold is intended for use, as an adjunct to sutures, for the reinforcement and repair of soft tissue where weakness exists and where the addition of a reinforcing material is needed to obtain the desired surgical result in patients undergoing breast surgery.
GalaFLEX 3DR™ Scaffold is designed to be used in patients undergoing soft tissue repair and reinforcement in medically necessary breast surgery procedures where the existing soft tissue is deficient to support the surgical repair. Examples of such breast surgery applications include reduction mammoplasty and breast revision surgery to correct a medical condition. The GalaFLEX 3DR™ Scaffold may also be used in cosmetic breast procedures.
Important safety information
Possible complications following implantation of GalaFLEX 3DR™ Scaffold includes 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
-
Preclinical data on file. Results may not correlate to clinical performance in humans.
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GalaFLEX 3DR™ Scaffold Instructions for Use
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Based on surgeon feedback.