Understanding, Avoiding, and Treating Potential Adverse Events Following the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization

April 2014 | Volume 13 | Issue 4 | Supplement Individual Articles | 35 | 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

True inflammatory granulomas are rare (incidence <0.1%) and have been reported with many currently available injectable fillers. They can be addressed clinically with injections of steroids and antimetabolites such as 5-FU and rarely recur after treatment.

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. Andre P, Lowe NJ, Parc A, Clerici TH, Zimmermann U. Adverse reactions to dermal fillers: a review of European experiences. J Cosmet Laser Ther. 2005;7(3-4):171-176.
  2. Engelhard P, Humble G, Mest D. Safety of Sculptra: a review of clinical trial data. J Cosmet Laser Ther. 2005;7(3-4):201-205.
  3. Lowe NJ, Maxwell CA, Patnaik R. Adverse reactions to dermal fillers: review. Dermatol Surg. 2005;31(11 Pt 2):1616-1625.
  4. Moyle GJ, Lysakova L, Brown S, et al. A randomized open-label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection. HIV Med. 2004;5(2):82-87.
  5. Valantin MA, Aubron-Olivier C, Ghosn J, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. AIDS. 2003;17(17):2471-2477.
  6. Sánchez-Carpintero I, Candelas D, Ruiz-Rodríguez R. Dermal fillers: types, indications, and complications. [Article in Spanish]. Actas Dermosifiliogr. 2010;101(5):381-393.
  7. Sherman RN. Avoiding dermal filler complications. Clin Dermatol. 2009;27:s23-s32.
  8. Fiore R 2nd, Miller R, Coffman SM. Mycobacterium mucogenicum infection following a cosmetic procedure with poly-L-lactic acid. J Drugs Dermatol. 2013;12(3):353-357.
  9. Lam SM, Azizzadeh B, Graivier M. Injectable poly-L-lactic acid (Sculptra): technical considerations in soft-tissue contouring. Plast Reconstr Surg. 2006;118(suppl 3):s55-s63.
  10. Levy RM, Redbord KP, Hanke CW. Treatment of HIV lipoatrophy and lipoatrophy of aging with poly-L-lactic acid: a prospective 3-year follow-up study. J Am Acad Dermatol. 2008;59(6):923-933.
  11. Mest DR, Humble G. Safety and efficacy of poly-L-lactic acid injections in persons with HIV-associated lipoatrophy: the US experience. Dermatol Surg. 2006;32(11):1336-1345.
  12. Lafaurie M, Dolivo M, Porcher R, Rudant J, Madelaine I, Molina JM. Treatment of facial lipoatrophy with intradermal injections of polylactic acid in HIV-infected patients. J Acquir Immune Defic Syndr. 2005;38(4):393-398.
  13. Sculptra [package insert]. 2012.
  14. Sculptra [package insert]. 2004.
  15. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-related facial lipoatrophy. HIV Med. 2006;7(3):181-185.
  16. Engelhard P, Knies M. Safety and efficacy of New-Fill (polylactic acid) in the treatment of HIV-associated lipoatrophy of the face (HALF) [abstract]. Presented at: XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain.
  17. Mest DR, Humble G. Safety and efficacy of intradermal poly-L-lactic acid (Sculptra™) injections in patients with HIV-associated facial lipoatrophy [abstract 59]. Antiviral Therapy. 2004;9:L36-L37.
  18. Sculptra Aesthetic [prescribing information]. 2012.
  19. Fitzgerald R, Vleggaar D. Facial volume restoration of the aging face with poly-l-lactic acid. Dermatol Ther. 2011;24(1):2-27.
  20. Butterwick K, Lowe NJ. Injectable poly-L-lactic acid for cosmetic enhancement: learning from the European experience. J Am Acad Dermatol. 2009;61(2):281-293.
  21. 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.
  22. Vleggaar D, Fitzgerald R, Lorenc ZP, et al. Consensus recommendations on the use of injectable poly-L-lactic acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(suppl 4):s44-s51.
  23. Goldman MP. Cosmetic use of poly-L-lactic acid: my technique for success and minimizing complications. Dermatol Surg. 2011;37(5):688-693.
  24. Lemperle G, Gauthier-Hazan N. Foreign body granulomas after all injectable dermal fillers: part 2. Treatment options. Plast Reconstr Surg. 2009;123(6):1864-1873.
  25. Lemperle G, Gauthier-Hazan N, Wolters M, Eisemann-Klein M, Zimmermann U, Duffy DM. Foreign body granulomas after all injectable dermal fillers: part 1. Possible causes. Plast Reconstr Surg. 2009;123(6):1842-1863.
  26. 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.
  27. Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118(suppl 3):s46-s54.
  28. Jham BC, Nikitakis NG, Scheper MA, Papadimitriou JC, Levy BA, Rivera H. Granulomatous foreign-body reaction involving oral and perioral tissues after injection of biomaterials: a series of 7 cases and review of the literature. J Oral Maxillofac Surg. 2009;67(2):280-285.

AUTHOR CORRESPONDENCE

Rebecca Fitzgerald MDfitzmd@earthlink.net
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