Clinical Characteristics and Use of Poly-4-Hydroxybutyrate Scaffold (GalaFLEX™) in Primary and Secondary Implant-Based Breast Reconstruction: A Structured Review of the Literature and Preliminary Single-Center Experience.

BACKGROUND: Poly-4-hydroxybutyrate (P4HB, e.g., GalaFLEX™) is a bioabsorbable matrix with a broad spectrum of indications in surgery. However, there is a lack of evidence and data on its utilization in Europe in the breast reconstruction setting. OBJECTIVE: To report preliminary clinical experience with P4HB scaffolds in implant-based breast reconstruction, with a focus on operative technique and complication predictors, complemented by a structured literature review. METHODS: This single-center retrospective study included 20 patients with 31 operated breasts, who underwent mastectomy with implant-based reconstruction in combination with P4HB scaffold. Patient-specific and mastectomy-specific factors were evaluated in the timeframe from January 2024 to January 2025. Statistical analyses were performed using nonparametric and regression-based methods. RESULTS: Major complications were recorded for 25.8% of breasts. Higher BMI was associated with increased risk of seroma formation (p = 0.044). Lower resection weight was associated with more frequent rippling/asymmetry (p = 0.011) and showed a trend toward skin and/or NAC necrosis (p = 0.057), whereas smaller implants were linked to necrosis of the skin envelope (p = 0.027), and larger implants to seroma formation (p = 0.031). The Stewart approach mastectomy had lowest rates of seromas (p = 0.022). The specific P4HB utilization technique did not show significant associations with reported outcomes. More rippling/asymmetry were observed when P4HB was used without additional dermal or muscle flaps (28% vs. 0%). Our structured review identified 4 studies with 418 operated breasts where P4HB was utilized. Overall complication rate reached up to 43%, and two authors have reported about an increased risk of capsular contracture in P4HB-patients. CONCLUSION: P4HB scaffolds did not show an increased complication signal in this exploratory cohort. Mastectomy-specific and anatomical factors seem to be the most consistent predictors of early complications. Our data suggest that a conservative implant sizing strategy may be beneficial in selected patients. LEVEL OF EVIDENCE IV: 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 .