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Facial Soft-Tissue Fillers Conference: Assessing the State of the Science

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Facial Soft-Tissue Fillers Conference: Assessing the State of the Science Facial Soft-Tissue Fillers conference: Assessing the State of the Science C. William Hanke, MD, Rod J. Rohrich, MD, MarianoBusso,MD,AlastairCarruthers,MA,BM,BCh,JeanCarruthers,MD,StevenFagien,MD, RebeccaFitzgerald,MD,RichardGlogau,MD,PhyllisE.Greenberger,MSW,Z.PaulLorenc,MD, EllenS.Marmur,MD,GaryD.Monheit,MD,AndreaPusic,MD,MHS,MarkG.Rubin,MD, BertholdRzany,MD,ScM,AnthonySclafani,MD,SusanTaylor,MD,SusanWeinkle,MD, MichaelF.McGuire,MD,DavidM.Pariser,MD,LaurieA.Casas,MD,KarenJ.Collishaw,RogerA.Dailey,MD, StephenC.Duffy,ElizabethJanEdgar,MS,BarbaraL.Greenan,KellyHaenlein,MHA, RonaldA.Henrichs,CAE,KeithM.Hume,MA,FloraLum,MD,DavidR.Nielsen,MD, Lisle Poulsen, Lori Shoaf, JD, William Seward, MA, Wendy Smith Begolka, MS, RobertG.Stanton,KatherineJ.Svedman,CAE,J.ReganThomas,MD,JonathanM.Sykes,MD, Carol Wargo, MA, and Robert A. Weiss, MD Dallas,Texas,andCarmel,Indiana Summary: The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers—from researchers to clinicians—and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence- based medicine reports in this growing field. ( J Am Acad Dermatol 2011;64:S66-85.) n November of 2008, the U.S. Food and Drug study of various dermal fillers.’’1 They are cited in Administration’s General and Plastic Surgery brackets at the end of the article for programmatic Panel held a meeting to receive an ‘‘update on reasons only. A complete summary of this meeting is I 1 safety information collected on dermal fillers in the provided. commercial setting, discuss current premarket and In response to the rapidly growing use of soft- postmarket approved study designs, and make rec- tissue fillers and the findings of the U.S. Food ommendations on general issues concerning the and Drug Administration panel, the following From the Department of Plastic Surgery, University of Texas conference—Proceedings report. J Am Acad Dermatol 2011;64 Medical Center, and the Department of Dermatology, Saint (Suppl):S53-65. Vincent Carmel Medical Center, Laser and Skin Surgery Center Citation of the articles in PRS follows this format: Rohrich RJ, Hanke of Indiana. CW. Facial Soft-Tissue Fillers: Assessing the State-of-the-Science Prepared for the American Academy of Dermatology and the Conference—Proceedings Report. Plast Reconstr Surg 2011;127 American Society of Plastic Surgeons and by The Lewin Group. (Suppl 2):9S-21S. Disclosures: Rod J. Rohrich, M.D., declares he is the recipient of Received for publication May 25, 2010; accepted November 5, 2010. research grant funds received by the University of Texas South- Correspondence to: Rod J. Rohrich, M.D., Department of Plastic western Medical Center from Medicis, Contura, Mentor (dermal Surgery, University of Texas Southwestern Medical Center, 1801 fillers or botulinum toxin type A studies), and Baxter (fibrin Harry Hines Boulevard, Dallas, Texas 75390-9132, E-mail: sealant study). C. William Hanke, M.D., declares financial interest [email protected] or C. William Hanke, M.D., as a shareholder in Medicis and Allergan. In addition, he declares Department of Dermatology, Saint Vincent Carmel Medical having been the recipient of research support from Medicis, Center, Laser & Skin Surgery Center of Indiana, 13400 North Allergan, Merz, Dermik, and Galderma. For additional disclosure Meridian Street, Suite 290, Carmel, Ind. 46032 E-mail: information, please see the Disclosure Appendix in this issue. [email protected]. This supplement in its entirety is jointly published by the Journal 0190-9622/$36.00 of the American Academy of Dermatology and Plastic and Ó 2011 by the American Academy of Dermatology, Inc and Reconstructive Surgery. Copyright Ó 2011 by the American Society of Plastic Surgeons. Citation of the articles in the JAAD follows this format: Hanke CW, doi:10.1016/j.jaad.2011.02.009 Rohrich RJ, Busso M, Carruthers A, Carruthers J, Fagien S, et al. Facial Soft-Tissue Fillers: Assessing the State of the Science S66 JAM ACAD DERMATOL Hanke et al S67 VOLUME 64, NUMBER 4 Table I. PubMed literature search strategy Concept Search string Hits General terms for ‘‘dermal filler*’’ [tiab] OR ‘‘soft tissue filler*’’ [tiab] OR AND 621 dermal fillers OR ‘‘soft-tissue filler*’’ [tiab] OR ‘‘injectable filler*’’ [tiab] OR ‘‘wrinkle filler*’’ [tiab] OR ‘‘skin filler*’’ [tiab] OR ‘‘facial filler*’’ [tiab] OR ‘‘collagen* filler*’’ OR ((‘‘cosmetic techniques’’ [MH] OR ‘‘rejuvenation’’ [MH]) AND (‘‘collagen’’ [MH] OR ‘‘hyaluronic acid’’ [MH] OR ‘‘lactic acid’’ [MH] OR ‘‘durapatite’’ [MH] OR ‘‘polymethyl methacrylate’’ [MH] OR ‘‘silicone oils’’ [MH])) Collagen fillers ‘‘cosmoderm’’ OR ‘‘cosmoplast’’ OR ‘‘cymetra’’ OR ‘‘fascian’’ OR ‘‘zyderm’’ OR ‘‘zyplast’’ OR ‘‘glutaraldehyde-cross-linked collagen’’ OR ‘‘evolence’’ Hyaluronic acid fillers ‘‘juvederm’’ OR ‘‘perlane’’ OR ‘‘restylane’’ OR hylan- B gel [Substance Name] OR ‘‘hylaform’’ OR ‘‘puragen’’ OR ‘‘captique’’ Poly-L-lactic acid fillers ‘‘sculptra’’ OR ‘‘new-fill’’ [Substance Name] Calcium hydroxylapatite fillers ‘‘radiesse’’ Polymethyl methacrylate fillers ‘‘artefill’’ Limits (humans[MH] AND English[lang] NOT (editorial[pt] OR letter[pt] OR comment[pt]) NOT (review[pt] NOT (review[pt] AND (systematic[tiab] OR comprehensive[tiab] OR method*[tiab] OR medline*[tiab] OR pubmed*[tiab]))) The asterisk (*) is a ‘‘truncation symbol’’ or ‘‘wildcard,’’ which means that any characters that come after it are retrieved, including those with no other characters. The quotation marks (‘‘ ’’) mean that the search looked for the words as a phrase. The [tiab] means the search looked for the indicated term in the title or abstract. A search term with the [MH] after the term does not have the asterisk because it is a set MeSH thesaurus term and will not have any variations. groups convened the Facial Soft-Tissue Fillers: METHODOLOGY Assessing the State of the Science conference Search strategy on December 6 through 7, 2009, in Washington, A comprehensive search strategy was developed D.C.: to search PubMed, which includes access to MEDLINE, and citations for selected articles in life d American Academy of Dermatology (sponsor society) science journals not included in MEDLINE. The d American Academy of Facial Plastic and Recon- search strategy was designed to ensure broad cap- structive Surgery (supporting society) ture of all relevant articles. Search strings using MeSH d American Academy of Ophthalmology (support- (Medical Subject Headings, PubMed’s controlled ing society) vocabulary for indexing studies) terms and key text d e American Academy of Otolaryngology Head and terms were combined to produce the resulting Neck Surgery (supporting society) search strategy. Varied constructs of search terms d American Society for Aesthetic Plastic Surgeons were captured with the use of truncation (repre- (supporting society) sented by an asterisk). Additional parameters were d American Society for Dermatologic Surgery (sup- also applied to the search strategy, including limiting porting society) retrieval to articles with abstracts in English, and d American Society of Plastic Surgeons (sponsor focused on humans. Using the date limit function society) within PubMed, we limited our search to studies Please see the companion article that summarizes published since January 1, 1994. We also used a limit the conference proceedings. The purpose of this function in PubMed to exclude letters, editorials, and systematic literature review is to examine compre- commentaries. Table I lists the search terms and hensively and assess the available evidence and gaps parameters we applied. This search yielded a total of in the evidence related to soft-tissue fillers to inform 621 abstracts. and support the work of the state-of-the-science We conducted a title and abstract review of conference panel. these studies, applying inclusion/exclusion criteria S68 Hanke et al JAM ACAD DERMATOL APRIL 2011 Table II. Inclusion/exclusion criteria for Table III. Full-text studies by type of study and abstract/title review type of soft-tissue filler Included study types Type of study Collagen HA PLLA CaHA PMMA Other Total* Meta-analysis SR 0 1 1 0 0 2 4 Systematic review RCT 13 25 2 3 2 1 33 Clinical trial CCT 2 0 0 0 0 0 2 Randomized controlled trial UCT 1 13 4 15 0 8 41 Controlled clinical trial Cohort 1 4 7 2 1 4 18 Uncontrolled clinical trial Cross-sectional 0 1 0 1 0 1 3 Epidemiologic study Case series 17 39 19 11 10 20 97 Cohort study Total 34 83 33 32 13 36 198 Case-control study Cross-sectional study HA, Hyaluronic acid; PLLA, poly-l-lactic acid; CaHA, calcium Follow-up study hydroxylapatite; PMMA, polymethylmethacrylate; SR, systematic Evaluation study review; RCT, randomized controlled trial; CCT,
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