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Avoiding and Treating Dermal COSMETIC Avoiding and Treating Dermal Filler Complications Gottfried Lemperle, M.D., Summary: All fillers are associated with the risk of both early and late compli- Ph.D. cations. Early side effects such as swelling, redness, and bruising occur after Peter P. Rullan, M.D. intradermal or subdermal injections. The patient has to be aware of and accept Nelly Gauthier-Hazan, M.D. these risks. Adverse events that last longer than 2 weeks can be attributable to San Diego and Chula Vista, Calif.; technical shortcomings (e.g., too superficial an implantation of a long-lasting and Paris, France filler substance). Such adverse events can be treated with intradermal 5-flu- orouracil, steroid injections, vascular lasers, or intense pulsed light, and later with dermabrasion or shaving. Late adverse events also include immunologic phenomena such as late-onset allergy and nonallergic foreign body granuloma. Both react well to intralesional steroid injections, which often have to be re- peated to establish the right dose. Surgical excisions shall remain the last option and are indicated for hard lumps in the lips and visible hard nodules or hard granuloma in the subcutaneous fat. (Plast. Reconstr. Surg. 118 (Suppl.): 92S, 2006.) The aesthetic benefit the patient achieves with tempo- Food and Drug Administration in 1967 for cos- rary fillers is 90 percent technique and 10 percent metic use.6 A more viscous product, Silikon 1000, substance. With permanent fillers, it’s 99 percent tech- has been approved for retinal reattachment since nique. 1998 and used off-label as a dermal filler. Bovine Jean Carruthers1 collagen (Zyderm, Zyplast) was introduced in 1981 and 1983 and became the standard for in- ll injectable dermal fillers can cause compli- jectables. Artecoll has been distributed from 1994 cations. Late side effects can be divided into to 2006, and Restylane started its triumphant ad- Athose caused by insufficient training or tech- vance in 1997. Since that time, a variety of fillers nical errors during injection and those caused by have been introduced, mainly to the European immunologic (allergic and nonallergic) reactions market. Radiesse is approved for facial bone aug- to the injected substance. In the case of late, non- mentation and has been used off-label since 2003 allergic reactions, the pathologic substratum dif- for wrinkle treatment, and Sculptra is approved fers from injectable to injectable but can always be for facial human immunodeficiency virus lipodys- classified into one of three distinct forms of foreign trophy but has been used for wrinkle treatment body granuloma.2 The histologic reaction is always since 2005. The U.S. Food and Drug Administra- similar,3 and the trigger for this sudden stimulation tion approved Restylane in 2003, Hylaform in of macrophages might be a systemic infection of 2004, Captique in 2005, and Juvederm in 2006 for the patient.2 the treatment of facial wrinkles. DERMAL FILLERS Silicone, bovine collagen, Artecoll, and Resty- For a complete list of the FDA status and approved lane have been used worldwide.4,5 The first of uses for the fillers mentioned in this supplement, these, medical grade fluid silicone of 350 centist- please see Table 1. As of this article’s acceptance okes (cS), was manufactured by Dow Corning, for publication in Plastic and Reconstructive Surgery, Inc., from 1954 to 1992, but banned by the U.S. ArteFill, a product of Artes Medical, had not yet been approved by the FDA. For further informa- From the Division of Plastic Surgery, University of Califor- tion, please visit the following Web sites: www.plas- nia, Dermatology Institute, and a private cosmetic practice. ticsurgery.org/news_room/press_releases/Injectables-at-a- Received for publication March 12, 2006; accepted May 12, 2006. Glance.cfm or www.surgery.org/press/news-release. Copyright ©2006 by the American Society of Plastic Surgeons php?iidϭ320&sectionϭnews-botox. DOI: 10.1097/01.prs.0000234672.69287.77 92S www.PRSJournal.com Volume 118, Number 3S • Dermal Filler Complications The clinical persistence of an injectable and its Bovine Collagen effect on wrinkles depends on the amount, depth, and shape of the implant. A thin strand applied • Zyderm I, Zyderm II, and Zyplast (Inamed Aes- beneath a constantly moving wrinkle on a human thetics, Santa Barbara, Calif.). U.S. Food and face is absorbed faster than a round depot beneath Drug Administration approved. the skin on a rat forehead or a human forearm. • Koken Atelocollagen (Koken, Tokyo, Japan). The carrier substance, whether quickly or slowly resorbable, may also play an important role in Porcine Collagen persistence. So far, only one of the implants—with • the exception of silicone, polyacrylamide, and Permacol (Tissue Science Labs., England). • polymethylmethacrylate—is palpable longer than Fibroquel (Aspid, Mexico). • 9 months.7,8 Evolence (ColBar LifeScience, Herzliya, Is- Although all filler substances, resorbable or rael). The company’s claim that Evolence lasts nonresorbable, appear to be clinically and histo- up to 1 to 2 years has still to be proven clini- logically safe, all may exhibit undesirable clinical cally. side effects, and host defense mechanisms react differently to the various filler materials.1 Accord- Human Collagen ing to the histologic reaction that fillers stimulate, • they have been classified as “volumateurs,” with Cosmoderm, Cosmoplast (Inamed Aesthetics). U.S. Food and Drug Administration approved. little cellular invasion, and “stimulateurs,” with • strong cellular reactions.9 Because the mechanism Isolagen (Isolagen Technologies, Houston, of late inflammation or granuloma formation is Texas). Collagen from the patient’s own cul- tured fibroblasts; in clinical trials. still unknown, early histologic findings are not • useful in predicting possible late reactions to filler Fascian (Fascia Biosystems, Beverly Hills, substances. Such late complications can be con- Calif.). Strips from human fascia; U.S. Food and Drug Administration approved. firmed only by rigorous long-term clinical studies • and by government-enforced reporting to a cen- Cymetra (LifeCell Corporation, Branchburg, tralized independent implant registry. N.J.). Injectable microparticles from human To avoid or treat complications with dermal skin; U.S. Food and Drug Administration ap- fillers, knowledge of their composition, physio- proved. logic tissue reactions, absorption time, and per- So far, all collagen preparations disappear sistence is indispensable. Therefore, the fillers clinically within 4 to 6 months and are histologi- that are well-known and available worldwide are cally absorbed between 3 and 9 months, depend- described below with respect to one or more of ing on the volume injected.8 Cultured autologous these characteristics. fibroblasts (Isolagen) have yet to demonstrate their survival and effectiveness. Autologous Fat Grafts • Liposculpture with the patient’s own fat. Hyaluronic Acid Gels • Preadipocytes (Fidia Advanced Biopolymers, • Restylane (U.S. Food and Drug Administration Padua, Italy). No clinical data yet. approved), Perlane, Fineline, SubQ, Macrolane • Stem cells from adipose tissue (Cytori, Inc., (Q-Med, Uppsala, Sweden; and Medicis Aes- San Diego, Calif.). No clinical data yet. thetics, Scottsdale, Ariz.) derived from Strepto- Autologous fat is rarely permanent, and its fate coccus equi. is unpredictable. There are convincing anecdotal • Hylaform (Inamed Aesthetics); from rooster cases published,10 but no statistics are available on combs; Hylaform Plus, Hylaform Fineline, all fat graft survival. The key to long-term survival of U.S. Food and Drug Administration approved. injected fat (i.e., the development of functional • Juvederm 18, 24, and 30 (Leaderm, Paris; and preadipocyte or stem cell cultures) has yet to be Inamed Aesthetics). From Streptococcus equi; discovered. Then, another question may arise: U.S. Food and Drug Administration approval What happens to the surviving fat cells in the face, pending. when patients get obese in later years?11 Do they • Captique (Inamed Aesthetics; and Genzyme, enlarge the same way the fat cells enlarge at lo- Boston, Mass.); U.S. Food and Drug Adminis- cations from which they stem? tration approved. 93S Plastic and Reconstructive Surgery • September 1 Supplement, 2006 • Rofilan Hylan Gel (Rofil Medical Interna- facial wrinkles but is not U.S. Food and Drug tional, Breda, The Netherlands). Administration approved. • AcHyal (Tedec-Meiji Farma, Spain). • PMS 350 (Vikomed, Germany) is fluid silicone • Matridur (BioPolymer, Siershahn, Germany). of low viscosity (350 cS) similar to the former • Hyal-System (Merz Pharma, Frankfurt, Ger- Silicone 360 from Dow Corning. many); for two-dimensional augmentation. Slowly resorbable fluid fillers such as fluid • Puragen (Mentor Corp., Santa Barbara, Calif.); silicone4,6,13 and polyacrylamides dissipate into the contains lidocaine. tissue, are clinically inconspicuous, and cause little Natural fillers such as collagen and hyaluronic fibrosis. Large volumes, however, can dislocate in acids are broken down by enzymes, absorbed, or patients with loose connective tissue through mus- phagocytized slowly, with minimal histologic re- cle movement and gravity. They are considered action. After further purification of Restylane in “inert implants.”12 1999, its incidence of complications has been markedly reduced. Polyacrylamide Gels Polymethylmethacrylate Microspheres • Aquamid (Ferrosan AS, Copenhagen, Den- mark) polyacrylamide gel 2.5% in water. • Artecoll (Rofil Medical
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