Background Penile augmentation is among the fastest-growing male aesthetic procedures worldwide, yet comparative safety data in all major modalities remain fragmented, impeding evidence-based patient counselling and shared decision-making in sexual health practice. This systematic review and meta-analysis was undertaken to consolidate and critically appraise the available evidence. Methods Systematic searches were made from seven databases from inception through December 2024. Complications with penile augmentation procedures were classified using the Clavien-Dindo system. Risk of bias was assessed with RoB ver. 2.0, ROBINS-I, and the Newcastle-Ottawa Scale. Random-effects meta-analyses used the Freeman–Tukey transformation; between-subgroup heterogeneity was tested with the Q-between statistic. Four pre-specified sensitivity analyses and GRADE certainty ratings were conducted using PRISMA 2020; registered in PROSPERO (CRD420261374814). Results A total of 23 primary studies (9 randomised control trials, 14 observational; N = 2620; 8 countries) were included. The pooled complication rate was 14.9% (95% CI: 11.5–18.6%; I2 = 35.1%; prediction interval: 5.9–27.0%). Between-subgroup heterogeneity was statistically significant (Q-between = 18.42, d.f. = 5, P = 0.002). All cross-material comparisons are indirect (no head-to-head RCTs exist). Hyaluronic acid (HA) appeared numerically lowest (9.0%; 95% CI: 5.1–13.9%; GRADE: moderate). Girth gains from modalities ranged from 1.23–1.50 cm (dermal-fat grafts) to 2.50–3.50 cm (silicone implants). GRADE certainty was moderate for HA and very low for permanent materials. Conclusion Based on current indirect evidence, HA injection may be considered among the available minimally invasive options, with a complication profile that appeared more favourable than that of permanent materials, and with the added safety advantage of enzymatic reversibility. This finding is relevant to sexual health counselling practice. Head-to-head trials and validated patient-reported outcome measures are urgently needed.
Fonseca et al. (Mon,) studied this question.