U.S. Food and Drug Administration Authors Publish Articles on Dermal Filler Materials, Injections, Methods, and Skin Preparation (2017)

Sir: More than 90 percent of the patients receiving dermal filler implants are women. Infections are infrequent but have a devastating impact on quality of life. In particular, infections associated with permanent (nonbiodegradable) fillers are concerning because of the persistence of bacterial biofilm that colonizes these materials, which limits treatment options. Our research group at the Center for Devices and Radiological Health has been funded by the U.S. Food and Drug Administration Office of Women’s Health to research mechanisms that may be responsible for infections associated with dermal filler use. Over the past 3 years, we have studied how dermal filler materials, injection methods, and skin preparation techniques affect the safety of dermal filler use. Our project goal for dermal fillers is to PUT (i.e., prevent contamination, use safe materials, and treat infections effectively) an end to infections associated with the use of dermal fillers. Our research program plans to address all of these aspects of dermal filler–associated infections. We were encouraged by a recent article (“The Role of Bacterial Biofilm in Adverse Soft-Tissue Filler Reactions: A Combined Laboratory and Clinical Study” by Saththianathan et al.1) and accompanying discussion in Plastic and Reconstructive Surgery reporting a number of important findings about risk factors for dermal filler contamination and associated infections. In agreement with Saththianathan et al., the authors of this letter believe that it is important to research how the safety of dermal filler implants can be improved to continue to minimize risks to patients. In addition to commending the work done by Saththianathan et al., we want Plastic and Reconstructive Surgery readers to be aware of related work performed by the U.S. Food and Drug Administration on this important area of research. In April of 2016, we reported in Biomaterials that the elastic properties of a permanent dermal filler material (polyacrylamide) can significantly influence bacterial adhesion (approximately 3-log difference).2 Using electron and visible light microscopy to characterize the materials, we concluded that stiffer materials apparently did not self-seal as well after injection, resulting in micro cracks that bacteria could enter and colonize, forming biofilm within a few hours. We subsequently published an article in Nature Scientific Reports describing two in vitro models to study the process of dermal filler injection: a SimSkin model for studying injection styles, and a pigskin model for studying skin preparation.3 Using the SimSkin (SimSkin, Chicago, Ill.) model, we determined that multiple injections through the same site (the fanning style) increased the rate of bacterial transfer across the skin compared with other styles. Using the pigskin model, we determined that current skin preparation methods have poor efficacy to reduce biofilm bioburden. Combining the results from these two models, we concluded that the use of shallow injection depths and/or fanning, combined with current skin preparation methods, may increase the rate of potential bacterial transfer across the skin. We are currently completing studies exploring nonantibiotic interventions to reduce the biofilm bioburden on skin, and looking at biocompatible antimicrobials to determine whether they can protect dermal filler materials from colonization. With the health of women in the United States and worldwide in mind, we hope that together with Saththianathan et al. and others researching dermal filler–associated infections we can continue to improve the safety of dermal filler use. We applaud those innovators who are working to better understand these infections, and we hope to complement their work with models for testing potential mitigation strategies, and information gleaned from our research on how to interrupt pathogenesis. We encourage further feedback and discussion from the Plastic and Reconstructive Surgery community on this issue. DISCLAIMER The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. The findings and conclusions in this communication have not been formally disseminated by the U.S. Food and Drug Administration and should not be construed to represent any Agency determination or policy. ACKNOWLEDGMENTS This work was supported by the U.S. Food and Drug Administration Office of Women’s Health. This project was supported in part by an appointment to the Oak Ridge Institute for Science and Education Research Participation Program at the Center for Devices and Radiological Health, U.S. Food and Drug Administration, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and U.S. Food and Drug Administration/Center. DISCLOSURE The authors have no financial interest to declare in relation to the content of this communication. K. Scott Phillips, Ph.D.Yi Wang, Ph.D.U.S. Food and Drug AdministrationOffice of Medical Products and TobaccoCenter for Devices and Radiological HealthOffice of Science and Engineering LaboratoriesDivision of Biology, Chemistry and Materials ScienceLaboratory of Microbiology and Infection ControlWashington, D.C.