Composition and Mechanism of Action of Poly-L-Lactic Acid in Soft Tissue Augmentation

April 2014 | Volume 13 | Issue 4 | Supplement Individual Articles | 29 | Copyright © April 2014


Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc

aHead of Cosmetic Dermatology in Private Practice, Geneva, Switzerland
bDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
cLorenc Aesthetic Plastic Surgery Center, New York, NY, USA

over time, with a quicker loss of correction, while PMMA is not biodegradable and theoretically results in permanent effects.16 However, a permanent effect may not be ideal, as cosmetic deficits often fluctuate with the increasing age of the patient.8

Studies Supporting the Mechanism of Action of Poly-L-Lactic Acid

In a murine model, a tissue response to and degradation of PLLA has been demonstrated.18 In one study, at 1 month postimplantation, PLLA microparticles became surrounded by mononuclear macrophages, mast cells, foreign body cells, and lymphocytes.18 At 3 months, increased collagen fiber deposits and a substantial decrease in cell numbers were observed, and at 6 months collagen production continued to increase with reductions in the number of fibrocytes and mononuclear macrophages. PLLA degradation continued throughout this time period, with decreases of 6%, 32%, and 58% at 1, 3, and 6 months, respectively.18 In guinea pigs, the subcutaneous implantation of PLLA powder resulted in a very mild inflammatory response with evidence of a foreign body reaction at 1 week, marked fibroblastic activity and proliferation at 2 weeks, and gradual ingrowth of tissue fibers at 4 weeks, with no further indication of inflammatory reaction.19 These preclinical findings are consistent with human histologic observations showing progressive dissolution of PLLA over 9 months,16 a significant increase in mean levels of type I collagen at 6 months with an inflammatory response similar to baseline,20 and gradual ingrowth of type I collagen 8 to 24 months post-injection.1

SUMMARY

Poly-L-lactic acid is a biocompatible, biodegradable polymer with established efficacy in numerous medical applications. The formulation of PLLA for use in soft tissue augmentation has been enhanced through inclusion of specific excipients and tight control over the physical and chemical attributes of PLLA microparticles.
When evaluating the clinical utility of biocompatible materials, PLLA provides a relatable example because it exerts its effects through the induction of a desired host response. This response leads to encapsulation of the microparticles, fibroplasia, PLLA degradation, and prolonged collagen synthesis, which generates new volume and structural support in a gradual, progressive manner. The consistent nature of the PLLA microparticles, coupled with an optimized injection technique, allows clinicians to achieve a controlled, predictable cosmetic effect.

DISCLOSURES

Danny Vleggaar MD has been a medical consultant for Sinclair IS Pharma, France; PharmaSwiss SA, Switzerland; Valeant Eastern Europe; and Cutanea Life Sciences, Inc. He also has been a trainer for Valeant Pharmaceuticals International, Inc./Medicis Corporation. Rebecca Fitzgerald MD has been a consultant and speaker for Valeant Pharmaceuticals North America LLC/Medicis Corporation; Merz Aesthetic, Inc; and Allergan USA, Inc.
Z. Paul Lorenc MD has been a consultant for Johnson & Johnson; La Lumiere, LLC; Medicis Corporation; Merz Corporation; and Mentor Corporation. In addition, he holds the following patents: US Patent 5/611,814–Resorbable Surgical Appliance for Use in Supporting Soft Tissue in a Superior Position; US Patent 60/950,423–Composition and Method of Use for Soft Tissue Augmentation/Drug Delivery; US Patent 12/797,710– Method for Measuring Change in Lip Size After Augmentation; and US Patent 13/604,012–Light Therapy Platform System.

REFERENCES

  1. Vleggaar D. Facial volumetric correction with injectable poly-L-lactic acid. Dermatol Surg. 2005;31(11 Pt 2):1511-1518.
  2. Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118(suppl 3):s46-s54.
  3. Sculptra Aesthetic [prescribing information]. 2012.
  4. Williams DF. On the mechanisms of biocompatibility. Biomaterials. 2008;29(20):2941-2953.
  5. Ratner BD, Bryant SJ. Biomaterials: where we have been and where we are going. Annu Rev Biomed Eng. 2004;6:41-75.
  6. Vleggaar D, Fitzgerald R, Lorenc ZP. The history behind the use of injectable poly-L-lactic acid for facial and nonfacial volumization: the positive impact of evolving methodology. J Drugs Dermatol. 2014;13(suppl 4):s32-s34.
  7. Lemperle G, de Fazio S, Nicolau P. ArteFill: a third-generation permanent dermal filler and tissue stimulator. Clin Plast Surg. 2006;33(4):551-565.
  8. Fitzgerald R, Vleggaar D. Facial volume restoration of the aging face with poly-l-lactic acid. Dermatol Ther. 2011;24(1):2-27.
  9. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-Llactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
  10. Schierle CF, Casas LA. Nonsurgical rejuvenation of the aging face with injectable poly-L-lactic acid for restoration of soft tissue volume. Aesthet Surg J. 2011;31(1):95-109.
  11. Butterwick K. Understanding injectable poly-L-lactic acid. Cosmet Dermatol. 2007;20:388-392.
  12. Rotunda AM, Narins RS. Poly-L-lactic acid: a new dimension in soft tissue augmentation. Dermatol Ther. 2006;19(3):151-158.
  13. Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol. 2004;3(4):385-389.
  14. Palm MD, Goldman MP. Patient satisfaction and duration of effect with PLLA: a review of the literature. J Drugs Dermatol. 2009;8(suppl 10):s15-s20.
  15. Wang F, Garza LA, Kang S, et al. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol. 2007;143(2):155-163.
  16. Lemperle G, Morhenn V, Charrier U. Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg. 2003;27(5):354-366.
  17. Marmur ES, Phelps R, Goldberg DJ. Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther. 2004;6(4):223-226.
  18. Gogolewski S, Jovanovic M, Perren SM, Dillon JG, Hughes MK. Tissue response and in vivo degradation of selected polyhydroxyacids: polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA). J Biomed Mater Res. 1993;27(9):1135-1148.
  19. Kulkarni RK, Pani KC, Neuman C, Leonard F. Polylactic acid for surgical implants. Arch Surg. 1966;93(5):839-843.
  20. Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922.

AUTHOR CORRESPONDENCE

Rebecca Fitzgerald MDfitzmd@earthlink.net
Close Menu