Plastic surgery technique is important, but simply repositioning poor-quality tissue does not address the underlying weakness.

As we age so does our skin. After the age of 20, our skin loses about 1% of its collagen each year.⁸ This gradual loss of collagen is what causes skin to become thinner and less elastic, resulting in natural sagging and wrinkles. There are many factors that can accelerate this effect, including:

Reshape Your Thinking About Soft Tissue Support

Plastic and Reconstructive surgery can restore more than just your body, it can also improve your self-confidence.¹

GalaFLEX® is a scaffold for plastic and reconstructive surgery that supports, elevates, repairs, and reinforces soft tissue.

• Generates tissue that is 3 to 4X stronger than the native tissue^{2, 3}
• Predictable performance that promotes healing and stability²
• Safely and naturally absorbed over time

Indications for Use

GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR scaffolds are indicated for use as bioresorbable scaffolds 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. These products, referred to as Galatea scaffolds, are 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 Galatea scaffolds 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 scaffolds for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffolds in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffolds in pediatric use has not been established. Consult the specific Galatea scaffold Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.

References

1. T.von Soest, et. al. “The effects of cosmetic surgery on body image, self-esteem, and psychological problems. ”Journal of Plastic, Reconstructive & Aesthetic Surgery. Volume 62, Issue 10, Oct 2009.
2. Preclinical data on file; results may not correlate to clinical performance in humans.
3. Deeken, Corey R., and Brent D. Matthews. “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 Surgery. 2013.
8. Corey R Deeken, PhD, et al. “Histologic and Biomechanical Evaluation of Crosslinked and Non-Crosslinked Biologic Meshes in a Porcine Model of Ventral Incisional Hernia Repair.” 23 Mar. 2011. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3782991/