The issue with soft tissue

Why support matters

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

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.

5,6

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.

5,6

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

32-48% of plastic surgery patients undergo a second procedure to revise their initial results.⁵'⁶

Native tissue only heals to 80%

of its original strength after surgery. 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 plastic surgery patients undergo a second procedure to revise their initial results.

5,6

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

4

32-48% of plastic surgery patients undergo a second procedure to revise their initial results.

5,6

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

1

Proper tissue support is an important factor in achieving lasting, natural-looking results. Plastic and reconstructive surgery patients deserve support.

Provides critical strength during the initial healing phase.

7-15

Promotes the maturation of stronger tissue.

7-13

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

7-13

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

Make tissue repair stronger with GalaFLEX™ Scaffold

7-11

Reinforce your plastic and reconstructive 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

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

Learn More

Supported tissue is stronger tissue

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

Promotes the maturation of stronger tissue.⁷⁻¹³

Leaves behind tissue 2-4x stronger than native tissue.⁷⁻¹³

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

Promotes the maturation of stronger tissue.⁷⁻¹³

Leaves behind tissue 2-4x stronger than native tissue.⁷⁻¹³

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

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

Helping soft tissue to heal stronger
Providing critical strength during initial healing phase¹⁴

Newly formed tissue (as a result of GalaFLEX™ Scaffold) provides support and stability to the tissue – and has been demonstrated to provide 2-4x greater strength then native tissue.

7-13

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

7-13

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

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

7-11

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

7,18

1.5-2 years

2 Weeks

1 year

1 month

Immediately
after surgery

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

Leaves behind tissue 2-4x stronger than native tissue

7-13

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

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

7-13

2-4x

Stronger

2-4x

GalaFLEX™ Scaffold has been demonstrated to provide 2-4 times greater strength than native tissue at 12-months following implantation⁷⁻¹³

Stronger

GalaFLEX™ Scaffold has been demonstrated to provide 2-4 times greater strength than native tissue at 12-months following implantation⁷⁻¹³

Support for the long run
Leaves behind tissue 2-4x stronger than native tissue⁷⁻¹³

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

Ready to elevate your plastic and reconstrutive surgery?
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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.

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.

References

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

Immediately
after surgery

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