What is GalaFLEX ®?
GalaFLEX® is a temporary, absorbable scaffold used to strengthen, stabilize and support weakened soft tissue. It was designed to provide support immediately after breast surgery, which allows your body to heal and create a healthy new tissue plane of primarily mature collagen.
GalaFLEX® scaffolds are made from a biologically derived polymer known as poly-4-hydroxybutyrate (P4HB™), which breaks downover time into CO2 and H2O, a process similar to absorbable stitches. This means that your body knows how to metabolize and completely absorb the scaffold safely and naturally.
GalaFLEX® scaffolds are offered in a variety of shapes for use in breast surgery procedures. Each GalaFLEX® scaffold is selected by your surgeon specific to your body’s shape and needs.
How does GalaFlex work?
During surgery, your surgeon will place the GalaFLEX® scaffold internal bra under your tissue.
The unique knit pattern of the scaffold encourages rapid cellular infiltration and the formation of new collagen which is a key component of healthy skin tissue. This newly formed tissue is pliable yet provides strength, support and stability to the elevated tissue.
After 18-24 months, the scaffold is essentially completely absorbed and eliminated from the body as water and carbon dioxide through natural physiologic pathways. No polymer metabolites remain after the degradation process is complete. The collagen tissue that remains is 3-4 times the original tissue strength.
The GalaFLEX® Family of Scaffolds are used in patients who need additional support because of weakened or deficient soft tissue, in breast surgery procedures. The GalaFLEX® Family of Scaffolds are used in breast procedures such as reduction mammoplasty, augmentation and revision surgeries.
Patients seeking to strengthen and stabilize weakened tissue during breast surgery may be a candidate for GalaFLEX® scaffold.
GalaFLEX® Scaffold Integration
1 Month – Healthy cells grow into the scaffold.
7 Months – Mature collagen is prevalent and provides reinforcement to the elevated tissue.
1 Year – A new healthy tissue plane 3-4 times stronger than the original tissue remains as the scaffold absorbs.
1,5-2Years – The scaffold absorption process is essentially complete.
Actual results may vary
The Issue With Tissue
As we age so does our skin. After the age of 20, our skin loses about 1% of its collagen each year. 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:
Weight loss Sun & UV exposure
Menopause (Causing an annual decrease of over 1% of skin thickness and 2% of collagen)
Previous surgery (Scars only heal to 80% of their initial strength)
In most breast surgery procedures, compromised and/or weakened soft tissue is tightened. Unfortunately, the tissue itself will not be stronger and gravity may once again cause tissue to droop or sag. This is why many surgeons choose to use a soft tissue support scaffold like GalaFLEX®. Not only does it provide internal breast support to newly lifted and tightened tissue immediately after surgery, but it also allows soft tissue to heal stronger.
Why Soft Tissue Support Matters
Clinical studies show that within 10 years following surgery, between 32% – 48% of patients undergo a second surgery to revise their initial surgical results. The most frequent reason for revisionary surgery among aesthetic implant patients was the development of ptosis (42%) or sagging of the tissue.
How Do I Know If GalaFLEX® Is Right For Me?
Patients seeking to strengthen and stabilize weakened tissue during breast surgery may be a candidate for GalaFLEX® scaffold. Please consult your surgeon to discuss if GalaFLEX® scaffold may be right for you.
Here are some questions you may want to discuss with your surgeon:
- How would you describe the quality of my breast tissue?
- Do I have risk factors for weakened breast tissue?
- Will my tissue alone provide enough strength and support?
- Does my tissue need additional soft tissue support?
- Do I need a GalaFLEX® Internal Bra™?
GalaFLEX® scaffold is designed to lift, reinforce and repair soft tissue where weakness exists in breast surgery. GalaFLEX® scaffold internal bra provides soft tissue support for cosmetic breast procedures.
- Comprehensive portfolio of biocompatibility testing reviewed by FDA and Notified Body during regulatory approval process for P4HB products.
- Produced by a safe biological fermentation process, standard in pharmaceutical production. Not of animal origin, Not synthetic.
- P4HB devices implanted in more than 3 million patients worldwide.
- P4HB extensively researched with more than 60 clinical and scientific publications.
- GalaFLEX® does not interfere with diagnostic mammograms or ultrasound techniques.
- The GalaFLEX® Family of Scaffolds 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.
- The GalaFLEX® Family of Scaffolds 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® Family of Scaffolds may also be used in cosmetic breast procedures.