Clinical Performance of GalaFLEX® (Poly-4-Hydroxybutyrate) Scaffold Application in Aesthetic and Reconstructive Breast Surgery: A Retrospective Study.

backgroundSoft-tissue support remains a critical factor in both reconstructive and aesthetic breast surgery. Bioresorbable synthetic scaffolds, such as poly-4-hydroxybutyrate (P4HB), have been introduced as an alternative to acellular dermal matrices to provide structural reinforcement while gradually integrating into host tissue. This study evaluates the clinical indications, surgical applications, and early postoperative outcomes associated with the use of a bioresorbable P4HB scaffold in implant-based breast surgery.

methodsA retrospective review was conducted of patients who underwent breast surgery with P4HB scaffold reinforcement. Surgical indications were analyzed per treated breast and categorized as oncologic or non-oncologic. Associated procedures, including fat grafting and implant exchange versus primary implantation, were recorded when available. Postoperative complications were assessed per patient. Descriptive statistics were used to summarize surgical indications, technical approaches, and outcomes.

resultsA total of 31 patients and 52 treated breasts were included. Surgical indications were evenly distributed between breasts with and without disease. All breasts with disease were managed in the context of post-mastectomy reconstruction. In breasts without disease, scaffold reinforcement was primarily used for contralateral symmetrization, followed by primary or revisional aesthetic procedures. Fat grafting was frequently performed as an adjunct technique. Most cases involved primary implant placement, with a small proportion representing revision surgery. The overall postoperative complication rate was low, with the majority of patients experiencing an uneventful recovery.

conclusionP4HB scaffold reinforcement demonstrated a favorable safety profile and versatile clinical applicability in both reconstructive and aesthetic breast surgery. Its integration into implant-based procedures, often in combination with adjunctive techniques, supports its role as a reliable option for soft-tissue support. Further studies with longer follow-up and comparative designs are needed to better define long-term outcomes and optimize indications. 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 .