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The information contained in this website is intended for Health Care Professionals.

If you are a patient, please consult with your physician. NOT INTENDED FOR U.S. AUDIENCES.

The issue with soft tissue 

Why support matters 

In fact, clinical studies show that within 10 years after plastic surgery, 32-48% of patients undergo a second procedure to revise their initial results—most commonly citing soft tissue weakness or deficiency as the reason behind these secondary procedures.

19-21

After age 20, our skin loses about 1% of its collagen each year —causing the soft tissue to become thinner and less elastic.     And after surgery, soft tissue only heals to 80% of its original strength.

1,2,3

4

Our skin loses 1% of its collagen each year after age 20.

1

Native tissue only heals to 80% of its original strength after surgery. 

4

32-48% of breast surgery patients undergo another breast surgery procedure to revise their initial results.

19-21

Our skin loses 1% of its collagen each year after age 20.

1

Native tissue only heals to 80% of its original strength after surgery. 

4

32-48% of breast surgery patients undergo another breast surgery procedure to revise their initial results.

19-21

Evaluating breast ptosis
The Regnault Grading System

22

22

NORMAL
FIRST DEGREE
SECOND DEGREE
THIRD DEGREE
GLANDULAR
PTOSIS
IMF

IMF = Intramammary fold

Proper tissue support is an important factor in achieving lasting, natural-looking results. Aesthetic breast surgery patients deserve support.

Reinforce your aesthetic breast surgery with the predictable strength of the GalaFLEX™ Scaffold Collection. Composed of biologically-derived poly-4-hydroxybutyate (P4HB), GalaFLEX™ Scaffold provide immediate soft tissue reinforcement and a foundation for long-term strength.

7-11,13

Supported tissue is stronger tissue
Make tissue repair stronger with GalaFLEX™ Scaffold

7-11

GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation

Support and strength

for the long run -3

1,2,11

Native tissue only heals to 80% its initial strength.

Tissue repaired with GalaFLEX™ Scaffold has been shown to be 3-4x stronger than native tissue strength at 12 months post operation.

4,7-10

Preclinical data on file. Results may not correlate to clinical outcomes.

Post-operation native tissue only heals to 80%⁴

Native tissue strength

Tissue repaired with GalaFLEX™ Scaffold ⁷⁻¹⁰

GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11

Support and strength

for the long run -3

Support for the long run 
Leaves behind tissue 3-4x stronger than native tissue.⁷⁻¹⁰

3-4x

GalaFLEX™ Scaffold has been demonstrated to provide 3-4 times greater strength than native tissue at 12-months following implantation⁷⁻¹⁰

Stronger

GalaFLEX Internal Bra™
provides long lasting support.

1,7-10

Before surgery
2 years later
5 years later
10 years later

Before and after photos of patients who received GalaFLEX Scaffold Internal Bra™ for soft tissue support during an aesthetic breast procedure, courtesy of Bruce Van Natta, MD. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Scaffold Internal Bra™ is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast lift with implant and GalaFLEX Internal Bra™

Before and after photos of patients who received GalaFLEX Scaffold Internal Bra™ for soft tissue support during an aesthetic breast procedure, courtesy of Bruce Van Natta, MD. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Scaffold Internal Bra™ is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.

Breast lift with implant and GalaFLEX Internal Bra™
Before surgery
2 years later
10 years later
5 years later

Provides critical strength during the initial healing phase.⁷⁻¹¹,¹⁵

Promotes the maturation of stronger tissue.⁷⁻¹⁰

Leaves behind tissue 3-4x stronger than native tissue.⁷⁻¹⁰

Provides critical strength during the initial healing phase.

7-11,15

Promotes the maturation of stronger tissue.

7-10

7-10

Leaves behind tissue 2-4x stronger than native tissue.

Helping soft tissue to heal stronger
Providing critical strength during initial healing phase

14

GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11

Support and strength

for the long run -3

The scaffold is essentially completely absorbed and eliminated from the body as water and carbon dioxide through natural physiologic pathways.⁷⁻¹³

1.5-2 years

>75% tissue integration has been demonstrated in preclinical studies.⁷⁻¹⁶

2 Weeks

Newly formed tissue (as a result of GalaFLEX™ Scaffold) provides support and stability to the tissue – and has been demonstrated to provide 3-4x greater strength then native tissue.⁷⁻¹³

1 year 

Healthy cells grow into the scaffold, gradually transferring the load from the scaffold to the ingrown tissue.⁷'¹⁸

1 month 
Immediately
after surgery

GalaFLEX™ Scaffold provides internal support to newly repaired tissue, and a lattice for new tissue ingrowth.

Preclinical data on file. Results may not correlate to clinical outcomes.

7 months

Mature collagen (i.e., Type I collagen) is prevalent.⁷⁻¹⁶'²³

7-11

Immediately
after surgery

GalaFLEX™ Scaffold provides internal support to newly repaired tissue, and a lattice for new tissue ingrowth.⁷⁻¹¹

2 Weeks

>75% tissue integration has been demonstrated in preclinical studies.⁷⁻¹⁶

1 month 

Healthy cells grow into the scaffold, gradually transferring the load from the scaffold to the ingrown tissue.⁷'¹⁸

7 months

Mature collagen (i.e., Type I collagen) is prevalent.⁷⁻¹⁶'²³

1 year 

Newly formed tissue (as a result of GalaFLEX™ Scaffold) provides support and stability to the tissue – and has been demonstrated to provide 3-4x greater strength then native tissue.⁷⁻¹³

1.5-2 years

The scaffold is essentially completely absorbed and eliminated from the body as water and carbon dioxide through natural physiologic pathways.⁷⁻¹³

Ready to elevate your plastic and reconstructive surgery? Let’s get started.

GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11

Support and strength

for the long run -3

  1.  Obaji S. Why does skin wrinkle with age? What is the best way to slow or prevent this process? Scientific American. September 26, 2005. Accessed February 6, 2024. https://www.scientificamerican.com/article/why-does-skin-wrinkle-wit/

  2. Choi JW, Kwon SH, Huh CH, Park KC, Youn SW. The influences of skin visco-elasticity, hydration level and aging on the formation of wrinkles: a comprehensive and objective approach. Skin Res Technol. 2013;19(1):e349-e355. doi:10.1111/j.1600-0846.2012.00650.x

  3. Thornton MJ. Estrogens and aging skin. Dermatoendocrinol. 2013;5(2):264-270. doi:10.4161/derm.23872

  4. Xue M, Jackson CJ. Extracellular Matrix Reorganization During Wound Healing and Its Impact on Abnormal Scarring. Adv Wound Care (New Rochelle). 2015;4(3):119-136. doi:10.1089/wound.2013.0485.

  5. Mimi Y. Wu Young, Kathleen A. Holoyda, David W. Chang, Outcomes of progressive tension donor-site closure in abdominal-based autologous breast reconstruction, Journal of Plastic, Reconstructive & Aesthetic Surgery,Volume 75, Issue 9, 2022, Pages 2991-2995.

  6. Adetayo, OA MD; Salcedo, SE; Gupta, SC. 1: THE USE OF ACELLULAR DERMAL MATRIX IN BREAST AND ABDOMINAL WALL SURGERY: A META-ANALYSIS OF OUTCOMES AND RISK FACTORS PREDICTIVE OF COMPLICATIONS. Plastic and Reconstructive Surgery 127():p 9, May 2011.

  7. Preclinical data on file. Results may not correlate to clinical outcomes.                              

  8. 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. Native abdominal wall tissue strength adapted from Deeken 2013 (69.7N +/- 13.6).                                           

  9. 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.

  10. Martin DP, Williams SF. Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial. Biochem Eng J 2003;16(2):97-105.

  11. 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.

  12. GalaFLEX™ Scaffold Instructions for Use.

  13. Williams SF, Martin DP, Moses AC. The History of GalaFLEX P4HB Scaffold. Aesthet Surg J. 2016;36(suppl 2):S33-S42. doi:10.1093/asj/sjw141.

  14. Ireton, Jordan E. et al. “The Role of Wound Healing and Its Everyday Application in Plastic Surgery: A Practical Perspective and Systematic Review.” Plastic and reconstructive surgery. Global open (2013).

  15. Critical wound healing period adapted from Ireton 2013 (6 weeks to 3 months).

  16. Stoikes NFN, Scott JR, Badhwar A, Deeken CR, Voeller GR. Characterization of host response, resorption, and strength properties, and performance in the presence of bacteria for fully absorbable biomaterials for soft tissue repair. Hernia. (2017) 21 (5):771–82. doi: 10.1007/s10029-017-1638-3.

  17. Data on file. Results may not correlate to clinical outcomes.

  18. Healthy tissue is defined by tissue with abundant mature collagen (as indicated by positive type I collagen staining) and vascularization (as shown by positive CD31 and smooth muscle actin stains) has quickly integrated into the scaffold. 

  19.  G. Patrick Maxwell, MD et al. "Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study." Aesthetic Surgery Journal 2015, Vol 35(2) 145–155.

  20. W. Grant Stevens, MD, et al. "Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel." Plastic and Reconstructive Surgery. April Supplement 2018.

  21. Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. Plast Reconstr Surg. 2017;140(6):1142-1150.

  22. Cuzalina, A., G. Tolomeo, P., & A. Mañón, V. (2023). Revisions for Complications of Aesthetic Breast Surgery. IntechOpen. doi: 10.5772/intechopen.112915.

  23. Data on file. Bruce Van Natta, MD Meridian Plastic Surgery pathology report of human GalaFLEX™ Scaffold tissue explant.​

References
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