Purpose <p>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.</p> Methods <p>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.</p> Results <p>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%).</p> Conclusion <p>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.</p> Level of Evidence II <p>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors &#xa0;<a href="http://www.springer.com/00266">www.springer.com/00266</a>.</p>

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

  • Andre Milani-Reis,
  • Juliana Almeida Oliveira,
  • Karine Eskandar,
  • Luiz Fábio Silva Ribeiro,
  • Luke Mattey,
  • Luca Maunsell-Pereira,
  • Joseph M. Escandon,
  • Mehmet Furkan Tunaboylu,
  • Doga Kuruoglu,
  • Lucas Kreutz-Rodrigues

摘要

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.

Level of Evidence II

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors  www.springer.com/00266.