Delayed immune-mediated adverse effects related to hyaluronic acid and acrylic hydrogel dermal fillers: Clinical findings, long-term follow-up and review of the literature

Journal of the European Academy of Dermatology and Venereology

Volumn 22, Issue 2, 2008, Pages 150-161

  Alijotas Reig, J ^a,b   Garcia gimenez, V ^c,d  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c Europa Medical Centre   (Spain)

^d Sociedad Española de Medicina y Cirugia Cosmética   (Spain)

Author keywords

Adverse effects; Dermalive; Ethylmethacrylate; Granulomas; Hyaluronic acid; Restylane treatment

Indexed keywords

ACRYLIC ACID DERIVATIVE; ACRYLIC HYDROGEL; ANTIHISTAMINIC AGENT; CETIRIZINE; COSMETIC; HYALURONIC ACID; HYDROXYCHLOROQUINE; INDOMETACIN; NONSTEROID ANTIINFLAMMATORY AGENT; PREDNISONE; SILICONE; TACROLIMUS; UNCLASSIFIED DRUG;

ADVERSE OUTCOME; ANGIONEUROTIC EDEMA; ARTICLE; CLINICAL ARTICLE; CLINICAL EVALUATION; DELAYED HYPERSENSITIVITY; DRUG DOSE REDUCTION; ERYTHEMA; FACE EDEMA; FOLLOW UP; HUMAN; IMMUNE RESPONSE; IMPLANTATION; LEUKOCYTOCLASTIC VASCULITIS; LICHEN; PRIORITY JOURNAL; PRURITUS; RASH; SJOEGREN SYNDROME; SKIN BIOPSY; SKIN DISEASE; SKIN GRANULOMA; SKIN INDURATION; SKIN MANIFESTATION; SKIN NODULE; SKIN SWELLING; URTICARIA;

BIOPSY; FOLLOW-UP STUDIES; GRANULOMA, FOREIGN-BODY; HOSPITALS, TEACHING; HUMANS; HYALURONIC ACID; HYDROGEL; HYPERSENSITIVITY, DELAYED; PROSPECTIVE STUDIES; PROSTHESES AND IMPLANTS; SKIN; SURGERY, PLASTIC; TIME FACTORS;

EID: 38349003159     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/j.1468-3083.2007.02354.x     Document Type: Article

References (75)

1. De Boulle K. Management of complications after implantation of fillers. J Cosmet Dermatol 2004; 3: 2-15.
2. Ellis DA, Makdessian AS, Brown DJ. Survey of future injectables. Facial Plast Surg Clin North Am 2001; 9: 405-411.
3. Frank PJ. Cosmetic symposium: Restylane. The Dermatologic Society of Greater New York. http://www.dermsociety.org/default.asp?id=3&aui= sa&aid=35 (last accessed: February 2, 2005).
4. Engelman DE, Bradley B, Goldberg DJ. Dermal fillers: Complications and informed consent. J Cosmet Laser Ther 2005; 7: 29-32.
5. 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: 171-176.
6. Duffy DM. Complications of fillers: Overview. Dermatol Surg 2005; 31: 1626-1633.
7. Bergeret-Galley C. Comparison of resorbable soft tissue fillers. Aesthetic Surg J 2004; 24: 33-46.
8. Piacquadio D, Jarcho M, Goltz R. Evaluation of hylan b gel as a soft-tissue augmentation implant material. J Am Acad Dermatol 1997; 36: 544-549.
9. Larsen NE, Pollak CT, Reiner K, Leshchiner E, Balazs EA. Hylan gel biomaterial: Dermal and immunologic compatibility. J Biomed Mater Res 1993; 27: 1129-1134.
10. Frank PJ. Cosmetic symposium: Restylane. Dermatologic Society of Greater New York. http://www.dermsociety.org/default.asp?id (last accessed: February 14, 2005).
11. Bergeret-Galley C, Latouche X, Illouz Y-G. The value of a new filler material in corrective and cosmetic surgery: DermaLive DermaDeep. Aesthetic Plast Surg 2001; 25: 249-255.
12. Vitali C, Bombardieri S, Jonsson R et al. Classification criteria for Sjögren syndrome: A revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 2002; 61: 554-558.
13. Steenkiste E, Marien K, van den Oord J. Dermalive granuloma: A lesion with distinctive histological features. Internet J Dermatol 2005; 3: 1-9.
14. Alster TS, West TB. Human-derived and new synthetic injectable materials for soft-tissue augmentation: Current status and role in cosmetic surgery. Plast Reconstr Surg 2001; 105: 2515-2525.
15. Garcia-Domingo MI, Alijotas-Reig J, Cistero-Bahima A, Tresserra F, Enrique E. Disseminated and recurrent sarcoid-like panniculitis due to bovine collagen injections. J Invest Allergol Clin Immunol 2000; 10: 107-109.
16. Alijotas-Reig J, Garcia-Domingo MI. [Silicone and autoimmune diseases]. An Med Interna 1998; 15: 276-283. Article in Spanish.
17. Christensen L, Breiting V, Janssen M, Vuust J, Hogdall E. Adverse reactions to injectable soft tissue permanent fillers. Aesthetic Plast Surg 2005.
18. Pons-Guiraud A. Actualisation des effets secundaires des produits de comblements des rides. Now Dermatol 2003; 22: 205-210.
19. Reisberger EM, Landthaler M, Wiest L, Schröeder J, Stolz W. Foreign body granulomas caused by polymethylmethacrylate microspheres. Arch Dermatol 2003; 139: 17-20.
20. Hoffmann C, Schuller-Petrovic S, Soyer HP, Kerl H. Adverse reactions after cosmetic lip augmentation with permanent biologically inert implant materials. J Am Acad Dermatol 1999; 40: 100-102.
21. Lowe NJ, Maxwell CA, Patnaik R. Adverse reactions to dermal fillers: review. Dermatol Surg 2005; 31: 1616-1625.
22. Requena C, Izquierdo MJ, Navarro M et al. Adverse reactions to injectable aesthetic microimplants. Am J Dermapathol 2001; 23: 197-202.
23. Rudolph C, Soyer P, Schuller-Petrovic S, Kerl H. Foreign body granulomas due to injectable aethetic microimplants. Am J Surg Pathol 1999; 23: 113-117.
24. Lombardi T, Samson J, Plantier F, Husson C, Kuffer R. Orofacial granulomas after injection of cosmetic fillers. Histopathologic and clinical study of 11 cases. J Oral Pathol Med 2004; 33: 115-120.
25. Matarasso ST. Understanding and using hyaluronic acid. Aesthetic Surg J 2004; 24: 361-364.
26. Petrella RJ, Di Silvestro MD, Hildebrand C. Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee: A randomised, double-blind, placebo-controlled clinical trial. Arch Intern Med 2002; 162: 292-298.
27. Raynauld JP, Torrance GW, Band PA et al. A prospective, randomised, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1of 2): Clinical results. Osteoarthritis Cartilage 2002; 10: 506-517.
28. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. Dermatol Surg 1998; 24: 1317-1325.
29. Bosniak S, Cantisano-Zilkha M, Glavas IP. Nonanimal stabilized hyaluronic acid for lip augmentation and facial rhytid ablation. Arch Facial Plast Surg 2004; 6: 379-383.
30. Brody HJ. Use of hyaluronidase in the treatment of granulomatous hyaluronic acid reactions or unwanted hyaluronic acid misplacements. Dermatol Surg 2005; 31: 893-897.
31. Lupton JR, Alster TS. Cutaneous hypersensitivity reaction to injectable hyaluronic acid gel. Dermatol Surg 2000; 26: 135-137.
32. Shafir R, Amir A, Gur E. Long-term complications of facial injections with Restylane. Plast Reconstr Surg 2000; 106: 1215-1216.
33. Raulin C, Greeve B, Hartschuh W, Soegding K. Exudative granulomatous reaction to hyaluronic acid (Hyalaform). Contact Dermatitis 2000; 43: 178-179.
34. Macedo OR, Recio AL. Complications after hyaluronic acid gel injections: case reports. J Eur Dermatol Venereol 2001; 15 (Suppl. 2): 147.
35. Micheels P. Human anti-hyaluronic acid antibodies. Is it possible? Dermatol Surg 2001; 27: 185-191.
36. Distante F, Bandierea R, Bellini R. Studio multicentrico italiano sull'efficacia e la tolerabilita dell'acido ialuronico di origen non animal (Restylane) nel trattamento degli inestetismi del volto. Gg Giornale Ital Dermatol Venereol 2001; 136: 293-301.
37. Honig JF, Brink U, Korabiowska M. Severe granulomatous allergic tissue reactions after hyaluronic acid injection in the treatment of facial lines and its surgical correction. J Craniofac Surg 2003; 14: 197-200.
38. Micheels P, Parish PH. Allergie a l'hyaluronane injectable. J Med Est Chir Derm 1998; XXVI: 55-58.
39. Fiedman PM, Mafong EA, Kauvar ANB, Geronemus RG. Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation. Dermatol Surg 2002; 28: 491-494.
40. Fernandez-Aceñero, Zamora E, Borbujo J. Granulomatous foreign body reaction against hyaluronic acid: Report a case after lip augmentation. Dermatol Surg 2003; 29: 1225-1226.
41. Soparkar CW, Patrinely JR. Managing inflammatory reaction to Restylane. Ophthal Plast Reconstr Surg 2005; 21: 151-153.
42. Jordan DR. Delayed inflammatory reaction to hyalironic acid (Restylane). Ophthal Plast Reconstr Surg 2005; 21: 401.
43. Rongioletti F, Catarini G, Sottofattori E, Rebora A. Granulomatous reaction after intradermal injections of hyaluronic acid gel. Arch Dermatol 2003; 139: 815-816.
44. Dal Sacco D, Cozzani E, Parodi A, Rebora A. Scar sarcoidosis alter hyaluronic acid injection. Int J Dermatol 2005; 44: 411.
45. Andree P. Evaluation of the safety of a non-animal stabilized hyaluronic acid (NASHA - Q-Medical, Sweden) in European countries: A retrospective study from 1997 to 2001. J Eur Acad Dermatol Venerol 2004; 18: 422-425.
46. Kavouni A, Stanec JJ. Human antihyaluronic acid antibodies. Dermatol Surg 2002; 28: 359-360.
47. Bussamara MV, Bagatin E, Hassun KM, Talarico S. Adverse effect of soft tissue augmentation with hyaluronic acid. J Cosmet Dermatol 2005; 4: 184-186.
48. Narins RS, Brandt F, Leyden J. Randomized double-bind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg 2003; 29: 588-595.
49. Sidwell RV, Dhillon AP, Butler PE, Rustin MH. Localized granulomatous reaction to a semi-permanent hyaluronic acid and acrylic hydrogel cosmetic fillers. Clin Exp Dermatol 2004; 29: 630-632.
50. Saylan Z. Facial fillers and their complications. Aesthetic Surg J 2003; 23: 221-224.
51. Antonovic D, Callen J. Development of sarcoidosis in cosmetic tattoos. Arch Dermatol 2005; 141: 869-872.
52. Leonhardt JM, Lawrence N, Narins RS. Angioedema acute hypersensitivity reaction to injectable hyaluronic acid. Dermatol Surg 2005; 31: 577-579.
53. Sasaki M, Miyazaki T, Nakamura T, Takahashi T, Miyauchi S, Iwata H. Immunogenicity of hylan g-f 20 in Guinea pigs and mice. J Rheumatol 2004; 31: 943-950.
54. Sasaki M, Miyazaki T, Takahashi T. Hylan G-F 20 induces delayed foreign body inflammation in Guinea pigs and rabbits. Toxicol Pathol 2003; 31: 321-325.
55. Roitt I, Brostoff J, Male D, eds. Inmunologia. Gower Medical Publishing Ltd, Barcelona, 1986.
56. Wang JY, Roehrl MH. Glycosaminoglycans are a potential cause of rheumatoid arthritis. Proc Natl Acad Sci USA 2002; 29: 14362-14367.
57. Volpé R. Autoimmune diseases. Encyclopedia of Life Sciences. Nature Publishing Group, New York, 2001: 1-7.
58. Fukui M, Whittlessey K, Metcalfe DD, Dastych J. Human mast cells express the hyaluronic acid-binding isoform of CD44 and adhere to hyaluronic acid. Clin Immunol 2000; 94: 173-178.
59. Filion MC, Phillips NC. Pro-inflammatory activity of containing DNA in hyaluronic acid preparations. J Pharm Pharmacol 2001; 53: 556-561.
60. Passy S. Implantes de polimetacrilato. Un nuevo método para corregir defectos corporales sin cirugía. International J Cosmetic Medical Surg (ed. sp) 2002; 4: 23-27.
61. Lemperle G, Kind P. Biocompatibility of Artecoll. Plast Reconstr Surg 1999; 103: 338-340.
62. Christen U, von Herrath MG. Infections and autoimmunity - good or bad? J Immunol 2005; 174: 7481-7486.
63. Arbuckle MR, McClain MT, Rubertone MV et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med 2003; 349: 1526-1533.
64. Loewe NJ, Maxwell A, Loewe P, Duick MG, Shah K. Hyaluronic acid skin fillers: Adverse reactions and skin testing. J Am Acad Dermatol 2001; 45: 930-933.
65. Zardawi IM, Chan I. Synvisc perisynovitis. Pathology 2001; 33: 519-520.
66. Roos J, Epaulard O, Juvin R, Chen C, Pavese P, Brion JP. Acute pseudoseptic arthritis after intraarticular sodium hyaluronan. Joint Bone Spine 2004; 71: 352-354.
67. Michou L, Job-Deslandre C, de Pinieux G, Kahan A. Granulomatous synovitis after intraarticular Hylan G-20. A report of two cases. Joint Bone Spine 2004; 71: 438-440.
68. Marino AA, Waddell DD, Kolomytkin OV, Pruett S, Sadavisan KK, Albright JA. Assessment of immunologic mechanism for flare reactions to Synvisc. Clin Orthop Relat Res 2006; 442: 187-194.
69. James DG, Williams WJ. Sarcoidosis and other granulomatous disorders. In: Smith LLH, ed. Major Problems in Internal Medicine. W.B. Saunders Co., Philadelphia, 1985; 24: 1-254.
70. Simons FER. Advances in H1-antihistamines. N Engl J Med 2004; 351: 2203-2217.
71. Rynes RI. Antimalarial drugs. In: Kelley WN, Harris ED, Ruddyn S, Sledge CB, eds. Textbook of Rheumatology, 4th edn. W.B. Saunders, Philapelphia, 1993: 731-742.
72. Wozniacka A, Lesiak A, Narbutt J, McCauliffe DP, Sysa-Jedrzejowska A. Chloroquine treatment influences proinflammatory cytokine level in systemic lupus erythematosus patients. Lupus 2006; 15: 268-275.
73. Brody HJ. Use of hyaluronidase in the treatment of granulomatous hyaluronic acid reactions or unwanted hyaluronic acid misplacement. Dermatol Surg 2005; 31: 893-897.
74. Vedamurthy M. Soft tissue augmentation -use of hyaluronic acid as dermal filler. Indian J Dermatol Venerol Leprol 2004; 70: 383-387.
75. Lambros V. The use of hyaluronidase to reverse the effects of hyaluronic acid fillers. Plast Reconstr Surg 2004; 114: 277.