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Performance and Safety of Hyaluronic Acid-Based Gynaecological Filler for Labia Majora Augmentation: A Randomised
Elena Fasola1,2, Dhouha Dridi3, Rebecca Susanna Degliuomini1
1Obstetrics and Gynaecology Unit, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy.
Life (Basel, Switzerland)
|July 28, 2026
Summary
Hyaluronic acid (HA) fillers significantly improved sexual function and aesthetics in women with labia majora atrophy. This minimally invasive treatment showed good safety and patient satisfaction, warranting further study.
Area of Science:
- Gynecological Aesthetics
- Minimally Invasive Procedures
- Regenerative Medicine
Background:
- Labia majora atrophy impacts aesthetics and sexual function due to aging and hormonal changes.
- Hyaluronic acid (HA) fillers offer a potential minimally invasive solution for labia majora volume restoration.
- Limited clinical data currently exists on the efficacy and safety of HA fillers for this indication.
Purpose of the Study:
- To evaluate the efficacy and safety of cross-linked hyaluronic acid (HA) filler injections for treating labia majora hypotrophy.
- To assess improvements in sexual function, aesthetic appearance, and patient satisfaction post-treatment.
- To monitor for any adverse events associated with the procedure.
Main Methods:
- A randomized, single-center, double-arm study involving 76 women aged 40-65 with labia majora hypotrophy.
- Treatment group (n=40) received HA filler injections; control group (n=36) received no intervention.
- Primary endpoints included Female Sexual Function Index (FSFI) scores and Motakef classification at six months; secondary endpoints included GAIS, PSS, and patient satisfaction.
Main Results:
- Significant improvements in FSFI scores (p < 0.0001) and Global Aesthetic Improvement Scale (GAIS) scores (p < 0.0001) were observed in the treatment group at six months.
- The procedure was well-tolerated with minimal pain (mean NRS: 1.4 ± 1.2) and no serious adverse events.
- Transient, mild local reactions were the only reported side effects, indicating a favorable safety profile.
Conclusions:
- Hyaluronic acid (HA)-based fillers demonstrate potential as a safe and effective minimally invasive option for labia majora augmentation.
- Treatment resulted in enhanced sexual function, improved aesthetic appearance, and increased patient satisfaction.
- Preliminary findings suggest efficacy, but further long-term investigations are warranted to confirm these results.