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  • Print publication year: 2010
  • Online publication date: February 2010

Ch. 7 - ArteFill

Summary

INTRODUCTION

The demand for safe, effective, long-lasting, and biocompatible dermal filler materials is increasing as a growing number of patients seek minimally invasive options for aesthetic improvement. For a substance or device to be amenable for soft tissue augmentation, in addition to producing the desired cosmetic results, the product must be well tolerated, exhibit a minimum of undesirable reactions, and be nonteratogenic, noncarcinogenic, and nonmigratory. In addition, the material or device must be easy to use and provide predictable, persistent correction through reproducible implantation techniques. Finally, in the United States, the Food and Drug Administration (FDA) review and approval of such products not only substantiates they meet safety and efficacy requirements but also assures adherence to important manufacturing and product labeling requirements postapproval.

Numerous attempts have been made to develop safe biological (e.g., collagen, hyaluronic acid) or synthetic (man-made) materials to fill unwanted wrinkles and scars. Currently, in the United States, there are about twelve or more different soft tissue fillers approved for cosmetic use; in Europe, there are approximately eighty CE marked approved cosmetic fillers with many more available worldwide. Historically, biologic filler materials that use “natural-based” core substances such as collagen and hyaluronic acid materials have predominated the marketplace. These materials, whether they are derived from a bioengineered or extracted from a natural source, typically have been modified to improve tolerability (e.g., removal of impurities) and modified to improve durability (e.g., cross-linked).

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Augmentation Fillers
  • Online ISBN: 9780511674853
  • Book DOI: https://doi.org/10.1017/CBO9780511674853
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REFERENCES
Klein, A.W. and Elson, M.L. The history of substances for soft tissue augmentation. Dermatologic Surgery, 26 (2000), 1096–1105.
Murray, C.A., Zloty, D. and Warshawski, L.. The evolution of soft tissue fillers in clinical practice. Dermatology Clinics, 23 (2005), 343–363.
Andre, 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. Journal of the European Academy of Dermatology and Venereology, 18 (2004), 422–425.
Cheng, J.T., Perkins, S.W. and Hamilton, M.M.. Collagen and injectable fillers. Otolaryngologic Clinics of North America, 35 (2002), 73–85.
Lowe, N.J., Maxwell, C.A., Lowe, P., Duick, M.G. and Shah, K.. Hyaluronic acid skin fillers: adverse reactions and skin testing. Journal of the American Academy of Dermatology, 45 (2001), 930–933.
Monheit, G.D. and Coleman, K.M.. Hyaluronic acid fillers. Dermatologic Therapy, 19 (2006), 141–150.
Andre, P., Lowe, N.J., Parc, A., Clerici, T.H. and Zimmermann, U.. Adverse reactions to dermal fillers: a review of European experiences. Journal of Cosmetic and Laser Therapy, 7 (2005), 171–176.
ArteFill Instructions for Use. San Diego, CA, Artes Medical, Inc., 2006.
Cohen, S.R., Berner, C.F., Busso, M., Gleason, M.C., Hamilton, D., Holmes, R.E., Romano, J.J., Rullan, P.R., Thaler, M.P., Ubogy, Z. and Vecchione, T.R.. ArteFill: a long-lasting injectable wrinkle filler material- summary of the U.S. Food and Drug Administration trials and a progress report on 4- to 5-year outcomes. Plastic and Reconstructive Surgery, 118 (2006), 64S–76S.
Lemperle, G., Hazan-Gauthier, N. and Lemperle, M.. PMMA microspheres (Artecoll) for skin and soft-tissue augmentation. Part II: clinical investigations. Plastic and Reconstructive Surgery, 96 (1995), 627–634.
Lemperle, G., Romano, J.J. and Busso, M.. Soft tissue augmentation with Artecoll: 10-year history, indications, techniques, and complications. Dermatologic Surgery, 29 (2003), 573–587.
Mattioli-Belmonte, M., Giavaresi, G., Biagini, G., Virgili, L., Giacomini, M., Fini, M., Giantomassi, F., Natali, D. and Torricelli, P.. Tailoring biomaterial compatibility: in vivo tissue response versus in vitro cell behavior. International Journal of Artificial Organs, 26 (2003), 1077–1085.
Lemperle, G., Ott, H., Charrier, U., Hecker, J. and Lemperle, M.. PMMA microspheres for intradermal implantation: Part I. Animal research. Annals of Plastic Surgery, 26 (1991), 57–63.
Yuan, H.G., Kalfas, G. and Ray, W.H.. Suspension polymerization. Polymer Reviews, 31 (1991), 215–299.
Laeschke, K.. Biocompatibility of microparticles into soft tissue fillers. Seminars in Cutaneous Medicine and Surgery, 23 (2004), 214–217.
Matlaga, B.F., Yasenchak, L.P. and Salthouse, T.N.. Tissue response to implanted polymers: the significance of shapes. Journal of Biomedical Materials Research, 10 (1976), 391–397.
Lemperle, G., Fazio, S. and Nicolau, P.. ArteFill: a third-generation permanent dermal filler and tissue stimulator. Clinics in Plastic Surgery, 33 (2006), 551–565.
Lemperle, G., Rietz, R. and Lemperle, M.. First clinical experiences with Arteplast: PMMA microspheres injected beneath wrinkles and dermal defects. In Plastic Surgery, Vol. 2, ed. Hinderer, U.T.. (Amsterdam: Elsevier, 1992), pp. 539–541.
Carruthers, A. and Carruthers, J.D.A.. Polymethylmethacrylate microspheres/collagen as a tissue augmenting agent: personal experience over 5 years. Dermatologic Surgery, 31 (2005), 1561–1565.
Conejo-Mir, J.S., Guirado, S.S. and Munoz, M.A.. Adverse granulomatous reaction to Artecoll treated by intralesional 5-fluorouracil and triamcinolone injections. Dermatologic Surgery, 32 (2006), 1079–1082.
Gelfer, A., Carruthers, A., Carruthers, J., Jang, F. and Bernstein, S.C.. The natural history of polymethylmethacrylate microspheres granulomas. Dermatologic Surgery, 33 (2007), 614–620.
Artecoll Physician's Brochure. Breda, The Netherlands, Rofil Medical International B.V., 2005.
Piacquadio, D., Smith, S. and Anderson, R.. A comparison of commercially available polymethylmethacrylate-based soft tissue fillers. Dermatologic Surgery, 34 (2008), S48–S52.
Lemperle, G., Morehenn, V., Pestonjamasp, V. and Gallo, R.L.. Migration studies and histology of injectable microspheres of different sizes in mice. Plastic and Reconstructive Surgery, 113 (2004), 1380–1390.
Lemperle, G., Holmes, R.E., Cohen, S.R. and Lemperle, S.M.. A classification of facial wrinkles. Plastic and Reconstructive Surgery, 108 (2001), 1735–1750.