A Retrospective Case Series Reporting the Safety of a Polyvinyl Alcohol ( PVA ) Composite Filler for Facial Augmentation

Background A novel polyvinyl alcohol (PVA)‐based filler has been developed for durable facial augmentation. Despite its clinical application, long‐term real‐world data regarding its safety profile remain limited. Objective This study aimed to retrospectively assess the long‐term safety profile and clinical outcomes of this PVA‐based filler for facial augmentation. Methods A multi‐center, retrospective case series was conducted across eight aesthetic clinics in China. Medical records of patients who received the PVA‐based filler for facial augmentation between January 2022 and January 2025 with a follow‐up of at least 18 months were reviewed. Adverse events (AEs) were extracted from the original medical charts and follow‐up logs and were classified by time of onset, type, and severity. A post hoc descriptive efficacy assessment using the Global Aesthetic Improvement Scale (GAIS) and FACE‐Q was performed on a sub‐cohort with complete photographic documentation exceeding 12 months. Results A total of 279 patient charts were included, with a mean follow‐up period of 24.5 ± 7.2 months. Three patients (1.07%) reported at least one AE (totaling 4 events), all of which were early‐onset, transient, and mild injection site reactions that resolved spontaneously. No late‐onset adverse events were reported in this cohort. The descriptive efficacy analysis ( n = 18) demonstrated sustained corrective effects, with a 72.2% improvement rate on GAIS and high patient satisfaction scores on FACE‐Q. Conclusion In this retrospective cohort, the PVA‐based composite filler demonstrated a low incidence of adverse events, with absence of documented late‐onset complications in 279 patients. Descriptive observations of long‐term efficacy are encouraging; further prospective, controlled studies are warranted to objectively substantiate its durability and performance.