The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in Cosmetic Breast Surgery: A Systematic Review and Meta-Analysis.

[PURPOSE] The P4HB scaffold (GalaFLEX) is an effective tool in breast reconstruction, but its role in cosmetic breast procedures, such as mastopexy, requires further evaluation. We performed a proportions meta-analysis to assess the efficacy and safety of P4HB scaffold use in aesthetic breast surgery.

[METHODS] A systematic literature search was conducted in PubMed, Cochrane Library, and Embase through December 2024 for studies on cosmetic breast surgery using the P4HB scaffold that reported safety and efficacy outcomes. A random-effects model and Freeman-Tukey double arcsine transformation were applied. Statistical analyses were performed using R version 4.1.2.

[RESULTS] Three studies with 406 female patients (average age 39) were included, with mastopexy and augmentation-mastopexy being the most common procedures. Pooled analysis showed a delayed wound healing rate of 5.94 per 100 (95% CI: 0.34-16.62%), recurrent implant malposition at 0.47 per 100 (95% CI: 0.00-1.58%), infection at 0.42 per 100 (95% CI: 0.00-2.47%), seroma at 0.31 per 100 (95% CI: 0.00-1.32%), recurrent capsular contracture at 0.18 per 100 (95% CI: 0.00-1.21%), scaffold palpability at 0.11 per 100 (95% CI: 0.00-0.93%), and red breast syndrome at 0.00 per 100 (95% CI: 0.00-1.22%).

[CONCLUSION] This meta-analysis suggests that the P4HB scaffold may be a valuable adjunct in aesthetic breast procedures, potentially reducing complications such as implant malposition and capsular contracture, while showing low rates of other complications including delayed wound healing, infection, and seroma.

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