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Penile augmentation procedures: a systematic review and meta-analysis of techniques, materials, and safety outcomes
Thais Daniele Flores Fonseca1, Samyr Machado Querobino1
1Centro Universitário Una Itabira, Itabira, Minas Gerais, Brazil.
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.
