A Comprehensive Review of Long-Term Safety and Effectiveness of FACILLE Modified Sodium Hyaluronate Gel for Injection over 3 Years

摘要

FACILLE modified sodium hyaluronate gel was designed to be used for nasolabial fold (NLF) correction. However, no study has investigated the long-term safety and effectiveness of FACILLE. Thus, a retrospective study of 14 aesthetic clinics in China was conducted. This was the first large-scale, postmarketing study on FACILLE to evaluate the occurrence of adverse events (AEs) and provide essential information on the satisfaction of patients with FACILLE injections. This study recruited participants aged >18 years. FACILLE was injected into the NLFs on both sides of each participant’s face. The primary endpoint for safety was systemic or severe AEs at an injection site. Effectiveness was assessed on the basis of the participants’ subjective perceptions and satisfaction levels. Safety and effectiveness data were collected on the day of injection and at 2 weeks and 1, 3, 6, 9, 12, 18, 24, 30 and 36 months postinjection. In total, 1552 participants were enrolled (mean age, 29.1 years), and most of them (96.5%) were women. The mean injection volume was 1.39 ± 0.658 mL, and the average number of injections was 2.4 ± 1.68. AEs were reported by 205 participants (13.2%). All AEs occurred at local injection sites. No systemic or severe AEs were observed. Local pain was the most frequently reported AE regardless of the number of injections or the injection volume. Only eight AE cases were correlated with FACILLE administration, with two cases involving local allergic reactions. The participants self-reported that they perceived the procedure to have an effectiveness of ≥90% within 6 months postinjection although this percentage decreased substantially after 9 months. Their satisfaction level was >90% within 1 month postinjection but decreased gradually after 3 months. Our results indicate that the long-term safety of FACILLE injection is adequate. The high self-reported perceived effectiveness and satisfaction levels indicate the considerable potential of FACILLE injections for correcting NLFs.