Malar augmentation with a polymethylmethacrylate-enhanced filler: assessment of a 12-month open-label pilot study.

BACKGROUND: Most filler procedures in the United States are performed with hyaluronic acid (HA) derivatives. Artefill (Suneva Medical, Inc, San Diego, California), the only polymethylmethacrylate (PMMA)-enhanced dermal filler approved by the US Food and Drug Administration (FDA), has been well tolerated by patients for treatment of nasolabial folds and has a safety profile similar to other approved fillers.

OBJECTIVES: The authors investigate the safety and efficacy of Artefill for malar augmentation.

METHODS: This prospective, multisite, open-label study included a total of 24 patients with age-related lipoatrophy. Only patients with mild to moderate lipoatrophy were considered candidates for treatment. Artefill was injected in the supraperiosteal layer of the malar region, at a maximum volume of 6 mL (3 mL/side). Touch-up injections were performed at weeks 4 and 6, up to a maximum total volume of 8.8 mL. Standardized assessments of results were made at 2, 6, and 12 months. Outcome measures included the Global Aesthetic Improvement Scale (GAIS), change in malar lipoatrophy grade, and patient satisfaction. Standardized photographs of each patient were collected.

RESULTS: Average patient age was 48 ± 5 years. Average volume of injections was 5.55 ± 1.87 mL. Based on both the patient- and physician-rated GAIS, 95.8% of study participants were reported as being "improved" or "very much improved." The change in malar lipoatrophy grade was significantly improved from baseline to 1 year by 0.96 ± 0.98 (P < .0003). Patients also reported high levels of satisfaction, with 87.5% being "satisfied" or "very satisfied." There were no reported adverse safety events in the study.

CONCLUSIONS: Artefill demonstrated improvement in malar atrophy with a high level of patient satisfaction and an excellent safety profile. The absence of any adverse events in our study patients was notable, and we believe this is a result of the uniform nature of the PMMA particles in the Artefill and the strict and sterile manner in which this PMMA dermal filler is produced.