Consensus recommendations for soft-tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane)

Plastic and Reconstructive Surgery

Volumn 117, Issue 3 SUPPL., 2006, Pages

  Matarasso, Seth L ^a   Carruthers, Jean D ^b   Jewell, Mark L ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

1,4 BUTANEDIOL DIGLYCIDYL ETHER; 4 AMINOBENZOIC ACID; ACETYLSALICYLIC ACID; ACICLOVIR; ADRENALIN; ALPHA TOCOPHEROL; ANESTHETIC AGENT; ANTIINFLAMMATORY AGENT; ANTIVIRUS AGENT; ARTICAINE; BENZOCAINE; BOTULINUM TOXIN A; COLLAGEN IMPLANT; FAMCICLOVIR; FILLER; GLYCOPROTEIN; HYALURONIC ACID; HYALURONIDASE; LIDOCAINE; MUSCLE RELAXANT AGENT; N ACETYLGLUCOSAMINE; NEUROTOXIN; PROCAINE; RESTYLANE; SALICYLIC ACID; SEPTOCAINE; STABILIZING AGENT; SULFONAMIDE; TETRACAINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALACICLOVIR; DRUG DERIVATIVE;

ACNE; AGE DISTRIBUTION; AGING; ALLERGIC REACTION; BACTERIAL INFECTION; BIOSYNTHESIS; BLOOD VESSEL OCCLUSION; CLINICAL ASSESSMENT; CLINICAL PRACTICE; CLINICAL PROTOCOL; COMPARATIVE STUDY; CONCENTRATION RESPONSE; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; DISEASE SEVERITY; DRUG CONTRAINDICATION; DRUG EFFECT; DRUG FORMULATION; DRUG HYPERSENSITIVITY; EAR; EDEMA; ERYTHEMA; ESTHETIC SURGERY; ETHNIC GROUP; ETHNOLOGY; EYE SURGERY; EYEBROW; FACE; FOOD AND DRUG ADMINISTRATION; FOOT; GINKGO BILOBA; GRANULOMA; GRANULOMATOUS INFLAMMATION; HAND; HERB; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERICUM PERFORATUM; HYPERSENSITIVITY REACTION; IMMUNOREACTIVITY; INFECTION PREVENTION; INFORMED CONSENT; INJECTION SITE DISCOLORATION; INJECTION SITE ERYTHEMA; INJECTION SITE INFLAMMATION; INJECTION SITE NECROSIS; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; ITALY; LASER SURGERY; LIP; LIPOATROPHY; MANDIBLE; MASSAGE; NERVE BLOCK; NOSE; OUTCOME ASSESSMENT; PAIN; PANAMA; PATIENT ASSESSMENT; PATIENT COMPLIANCE; PATIENT EDUCATION; PATIENT SATISFACTION; PHYSICAL CHEMISTRY; PLASTIC SURGERY; POSTOPERATIVE COMPLICATION; PREVALENCE; PRIORITY JOURNAL; RADIOFREQUENCY ABLATION; RHYTIDOPLASTY; SAFETY; SCAR; SEX RATIO; SKIN SWELLING; SOFT TISSUE; SURGICAL TECHNIQUE; SWEDEN; TISSUE ENGINEERING; TOPICAL ANESTHESIA; TOPICAL TREATMENT; TREATMENT INDICATION; TREATMENT OUTCOME; TREATMENT PLANNING; UNITED STATES; VIRUS INFECTION; WRINKLE; CUTANEOUS PARAMETERS; PRACTICE GUIDELINE; STANDARD;

COSMETIC TECHNIQUES; HUMANS; HYALURONIC ACID; SKIN AGING;

EID: 33644911453     PISSN: 00321052     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.prs.0000204759.76865.39     Document Type: Conference Paper

References (71)

1. Cosmetic Surgery National Data Bank Statistics 2004. New York: American Society for Aesthetic Plastic Surgery, 2005.
2. Medicis Aesthetics, Inc. Restylane injectable gel (nonanimal stabilized hyaluronic acid; NASHA) (Package Insert). Scottsdale, Ariz.: Medicis Aesthetics.
3. Klein, A. W. Skin filling: Collagen and other injectables of the skin. Dermatol. Clin. 19: 491, 2001.
4. Stern, R. S. Treatment of photoaging. N. Engl. J. Med. 350: 1526, 2004.
5. Yaar, M., and Gilchrest, B. A. Skin aging: Postulated mechanisms and consequent changes in structure and function. Clin. Geriatr. Med. 17: 617, 2001.
6. Narins, R. S., and Bowman, P. H. Injectable skin fillers. Clin. Plast. Surg. 32:151, 2005.
7. Murray, C. A., Zloty, D., and Warshawski, L. The evolution of soft tissue fillers in clinical practice. Dermatol. Clin. 23: 343, 2005.
8. Owens, J. O. Soft tissue implants and fillers. Otolaryngol. Clin. North Am. 38: 361, 2005.
9. Ascher, B., Cerceau, M., and Baspeyras, M. Soft tissue filling with hyaluronic acid. Ann. Chir. Plast. Esthet. 49: 465, 2004.
10. Biesman, B. Soft tissue augmentation using Restylane. Facial Plast. Surg. 20: 171, 2004.
11. Kanchwala, S. K., Holloway, L., and Bucky, L. P. Reliable soft tissue augmentation: A clinical comparison of injectable soft-tissue fillers for facial-volume augmentation. Ann. Plast. Surg. 55: 30, 2005.
12. Obagi, S. Correction of surface deformities: Botox, soft-tissue fillers, lasers and intense pulsed light, and radiofrequency. Atlas Oral Maxillofac. Surg. Clin. North Am. 12: 271, 2004.
13. Matarasso, S. L. Understanding and using hyaluronic acid. Aesthetic Surg. J. 24: 361, 2004.
14. Baumann, L. Replacing dermal constituents lost through aging with dermal fillers. Semin. Cutan. Med. Surg. 23: 160, 2004.
15. Inamed Aesthetics. Zyderm collagen implant (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
16. Inamed Aesthetics. Zyplast collagen implant (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
17. Inamed Aesthetics. CosmoDerm human-based collagen (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
18. Inamed Aesthetics. CosmoPlast human-based collagen (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
19. Cell junctions, cell adhesion, and the extracellular matrix. In B. Alberts, A. Johnson, J. Lewis, M. Raff, K. Roberts, and P. Walter (Eds.), The Molecular Biology of the Cell. 4th Ed. New York: Garland Science, 2002. P. 1065.
20. Hascall, V.C., and Laurent, T.C. Hyaluronan: Structure and function. Available at http://www.glycoforum.gr.jp/science/hyaluronan/HA01/HA01E.html#I. Accessed September 22, 2005.
21. Balazs, E. A., and Denlinger, J. L. Clinical uses of hyaluronan. Ciba Found. Symp. 143: 265, 1989.
22. Inamed Aesthetics. Captique injectable gel (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
23. Inamed Aesthetics. Hylaform (hylan B gel) (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
24. Inamed Aesthetics. Hylaform Plus (hylan B gel) (Package Insert). Santa Barbara, Calif.: Inamed Aesthetics.
25. Malson, T., and Lindqvist, B. Gel of cross-linked hyaluronic acid for use as a vitreous humor substitute. European Patent 0185070, 1985.
26. Q-Med AB. NASHA product monograph. Uppsala, Sweden: Q-Med AB, 2000.
27. Duranti, F., Salti, G., Bovani, B., et al. Injectable hyaluronic acid gel for soft tissue augmentation: A clinical and histologic study. Dermatol. Surg. 24: 1317, 1998.
28. Olenius, M. The first clinical study using a new biodegradable implant for the treatment of lips, wrinkles, and folds. Aesthetic Plast. Surg. 22: 97, 1998.
29. Friedman, P. M., Mafong, E. A., Kauvar, A. N. B., et al. Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation. Dermatol. Surg. 28: 491, 2002.
30. Lowe, N. J., Maxwell, C. A., Lowe, P., et al. Hyaluronic acid skin fillers: Adverse reactions and skin testing. J. Am. Acad. Dermatol. 45: 930, 2001.
31. Lupton, J. R., and Alster, T. S. Cutaneous hypersensitivity reaction to injectable hyaluronic acid gel. Dermatol. Surg. 26: 135, 2000.
32. Micheels, P. Human anti-hyaluronic acid antibodies: Is it possible? Dermatol. Surg. 27: 185, 2001.
33. Narins, R. S., Brandt, F., Leyden, J., et al . A randomized, double blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol. Surg. 29: 588, 2003.
34. Bellew, S. G., Carrol, K. C., Weiss, M. A., et al. Sterility of stored nonanimal, stabilized hyaluronic acid gel syringes after patient injection. J. Am. Acad. Dermatol. 52: 988, 2005.
35. Bhatia, A. C., Arndt, K. A., Dover, J. S., et al. Bacterial sterility of stored nonanimal stabilized hyaluronic acid-based cutaneous filler. Arch. Dermatol. 141: 1317, 2005.
36. Rohrich, R. J. Personal communication. October 2005.
37. Taylor, S. Skin color: Biology, structure, function, and implications for dermatologic disease. J. Am. Acad. Dermatol. Suppl. 46: S41, 2002.
38. Grekin, R. C., and Auletta, M. J. Local anesthetics in dermatologic surgery. J. Am. Acad. Dermatol. 19: 599, 1988.
39. Huang, W., and Vidimos, A. Topical anesthetics in dermatology. J. Am. Acad. Dermatol. 43: 286, 2000.
40. Gmyrek, R. Local anesthesia and regional nerve block anesthesia. eMedicine.com. Available at http://www.emedicine.com/derm/topic824.htm. Accessed September 14, 2005.
41. Malamed, S. F. Handbook of Local Anesthesia. 5th Ed. New York: Elsevier Mosby, 2005.
42. Catterall, W., and Mackie, K. Local anesthetics. In J. G. Hardman, L. E. Limbid, and A. G. Gilman (Eds.), Goodman and Gilman's the Pharmacological Basis of Therapeutics. 10th Ed. New York: McGraw-Hill, 2001. Pp. 367-384.
43. Smith, K. C., Comite, S. L., Balasubramanian, S., et al. Vibration anesthesia: A noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol. Online. 10: 1. Available at http://dermatology.cdlib.org/ 102/therapy/anesthesia/comite.html. Accessed December 01, 2005.
44. Elson, M. L. Soft tissue augmentation techniques: Update on available materials. Cosmet. Dermatology 12: 13, 1999.
45. Bosniak, S., Cantisano-Zilkha, M., and Glavas, I. P. Nonanimal stabilized hyaluronic acid for lip augmentation and facial rhytid ablation. Arch. Facial Plast. Surg. 6: 379, 2004.
46. Patterson, C. N., and Powell, D. G. Facial analysis in patient evaluation for physiologic and cosmetic surgery. Laryngoscope 84: 1004, 1974.
47. Michaels, G., and Sather, A. H. Determinants of facial attractiveness in a sample of white women. Int. J. Adult Orthod. Orthognath. Surg. 9: 95, 1994.
48. Bisson, M., and Grobbelaar, A. The esthetic properties of lips: A comparison of models and nonmodels. Angle Orthodontist 74: 162, 2004.
49. Sclafani, A. P. Soft tissue fillers for management of the aging perioral complex. Facial Plast. Surg. 21: 74, 2005.
50. Sclafani, A. P., and Kwak, E. Alternative management of the aging jawline and neck. Facial Plast. Surg. 21: 47, 2005.
51. Questions and answers about avascular necrosis. Bethesda, Md.: National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. Available at http://www.niams.nih.gov/hi/topics/ avascular_necrosis/. Accessed September 10, 2005.
52. Carruthers, J., Fagien, S., Matarasso, S., and the Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type A in facial aesthetics. Plast. Reconstr. Surg. 114 (6 Suppl.): 1S, 2004.
53. Carruthers, J., Klein, A. W., Carruthers, A., et al. Safety and efficacy of nonanimal stabilized hyaluronic acid for improvement of mouth corners. Dermatol. Surg. 31: 276, 2005.
54. Carruthers, J., and Carruthers, A. A prospective, randomized, parallel group study analyzing the effect of BTX-A (Botox) and nonanimal sourced hyaluronic acid (NASHA, Restylane) in combination compared with NASHA (Restylane) alone in severe glabellar rhytides in adult female subjects: Treatment of severe glabellar rhytides with a hyaluronic acid derivative compared with the derivative and BTX-A. Dermatol. Surg. 29: 802, 2003.
55. Schanz, S., Schippert, W., Ulmer, A., et al. Arterial embolization caused by injection of hyaluronic acid (Restylane). Br. J. Dermatol. 146: 928, 2002.
56. Hanke, C. W., Higley, H. R., Jolivette, D. M., et al. Abscess formation and local necrosis after treatment with Zyderm or Zyplast collagen implant. J. Am. Acad. Dermatol. 25: 319, 1991.
57. Stegman, S. J., Chu, S., and Armstrong, R. C. Adverse reactions to bovine collagen implant: Clinical and histological features. J. Dermatol. Surg. Oncol. 14: 39, 1988.
58. Egidio, J. A., Arroyo, R., Marcos, A., et al. Middle cerebral artery embolism and unilateral visual loss after autologous fat injection into the glabellar area. Stroke 24: 615, 1993.
59. Hirmand, H. The tear trough and hyaluronic acid/Restylane: Is it a happy union? Presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery and the Aesthetic Surgery Education and Research Foundation, New Orleans, La., April 30-May 4, 2005. Paper no. 1714.
60. ISTA Pharmaceuticals, Inc. Vitrase (hyaluronidase injection, ovine) (Package Insert). Irvine, Calif.: ISTA Pharmaceuticals.
61. Brody, H. J. Use of hyaluronidase in the treatment of granulomatous hyaluronic acid reactions or unwanted hyaluronic acid misplacement. Dermatol. Surg. 31: 893, 2005.
62. Gooderman, M., and Solish, N. Use of hyaluronic acid for soft tissue augmentation of HIV-associated facial lipoatrophy. Dermatol. Surg. 31: 104, 2005.
63. Melzack, R., and Wall, P. D. Pain mechanisms: A new theory. Science 150: 971, 1965.
64. Alam, M., Amura, N., and Kaminer, M. S. Subcision for acne scarring: Techniques and outcomes in 40 patients. Dermatol. Surg. 31: 310, 2005.
65. American Diabetes Association. Preventive foot care in diabetes. Diabetes Care Suppl. 27: S79, 2004.
66. Wortzman, M. Personal communication. October 2005.
67. Soparkar, C. N., Patrinely, J. R., and Tschen, J. Erasing Restylane. Ophthal. Plast. Reconstr. Surg. 20: 317, 2004.
68. Soparkar, C. N., and Patrinely, J. R. Managing inflammatory reaction to Restylane. Ophthal. Plast. Reconstr. Surg. 21: 151, 2005.
69. Fernandez-Acenero, M. J., Zamora, E., and Borbujo, J. Granulomatous foreign body reaction against hyaluronic acid: Report of a case after lip augmentation. Dermatol. Surg. 29: 1225, 2003.
70. Narins, R., Jewell, M., Rubin, M., et al. Clinical conference: Management of rare events following dermal fillers - Focal necrosis and angry red bumps. Dermatol. Surg. (in press).
71. Joint ASPS and ASAPS Advisory: Injectables and fillers: Legal and regulatory risk management issues. Published online at www.plasticsurgery.com. June 13, 2005.