Novel Polymethylmethacrylate Soft Tissue Filler for the Correction of Nasolabial Folds

Abstract

BACKGROUND This paper presents interim results of a 5-year Food and Drug Administration postapproval study to evaluate the long-term safety and patient satisfaction of an advanced polymethylmethacrylate (PMMA)-based filler for the correction of nasolabial folds (NLFs). OBJECTIVE To report the incidence of adverse events, including granuloma formation, and subject satisfaction. MATERIALS AND METHODS Safety data were evaluated for 1,008 subjects treated. Treatment was administered at day 1 plus one or two additional touch-ups, as required, through day 60. Potential adverse events, subject satisfaction, and any additional cosmetic treatments received in the treatment area were evaluated over an 18-month follow-up period. RESULTS Approximately 6% (63/1,008) of patients reported 82 device-related adverse events. Overall, 19% (187/1,008) of subjects experienced adverse events, the majority of which were mild; none were unanticipated. There were 14 serious adverse events reported; none of which were device related. One granuloma was reported, which resolved completely with a single medical treatment. Subject satisfaction with treatment remained high (∼80% very satisfied or satisfied) throughout the follow-up period. CONCLUSION Results confirm and further support the long-term safety and efficacy of this PMMA filler for the correction of NLFs. Suneva Medical, Inc. sponsored this Food and Drug Administration clinical trial and provided editorial support.