Performance and Safety of Hyaluronic Acid-Based Gynaecological Filler for Labia Majora Augmentation: A Randomised...

Background: Labia majora atrophy is a common consequence of aging, hormonal changes, and medical conditions, leading to anatomical changes that affect both aesthetic appearance and sexual function. Hyaluronic acid (HA)-based fillers represent a promising, minimally invasive approach to restoring volume and improving the structural integrity of the labia majora. However, clinical data on their efficacy and safety remain limited. Objective: To evaluate the efficacy and safety of a cross-linked hyaluronic acid filler for the treatment of labia majora hypotrophy. Methods: This randomised, single-centre, double-arm study included 76 women aged 40-65 years with labia majora hypotrophy, allocated to either a treatment group receiving HA filler injections (n = 40) or a control group with no intervention (n = 36). Primary endpoints included changes in sexual function, assessed using the Female Sexual Function Index (FSFI) at six months, and anatomical assessment using the Motakef classification as an indirect measure of the labia majora proportion. Secondary endpoints included aesthetic improvement (Global Aesthetic Improvement Scale, GAIS), perceived stress (Perceived Stress Scale, PSS), and patient satisfaction. Safety was assessed through the systematic monitoring of adverse events. Results: At six months, FSFI scores significantly improved in the treatment group compared to the control group (p < 0.0001), indicating improved sexual function. GAIS scores demonstrated significantly higher aesthetic improvement in the treated group (p < 0.0001). No serious adverse events occurred, and procedure-related pain was minimal (mean NRS: 1.4 ± 1.2). The treatment was well tolerated, with only transient and mild local reactions reported. Conclusions: The findings suggest that HA-based gynaecological fillers may represent a safe and potentially effective minimally invasive option for labia majora augmentation, with improvements in sexual function, aesthetic appearance, and patient satisfaction. These results should be considered preliminary and warrant further long-term investigation.