Pre-Clinical Assessment of Early Interaction Between Absorbable P4HB Scaffolds and Silicone Breast Implants

Background Absorbable scaffolds such as poly-4-hydroxybutyrate (P4HB) are increasingly used in aesthetic breast surgery to support implants. However, the nature and timing of scaffold–implant interactions during early healing remain uncharacterized. Objectives Evaluate whether contact between P4HB Scaffolds and silicone implants can cause mechanical weaking of either device or wear-related particulate generation. Methods Two independent studies were performed. An animal study assessed early P4HB Scaffold-tissue integration. Characteristics and histology of scaffold explants were compared to native capsules after 4 weeks in a porcine silicone implant model. A separate benchtop study evaluated scaffold and implant mechanical integrity and particulate generation after interactive cyclic loading for 12 weeks, exceeding the in vivo integration period, to conservatively evaluate interaction. Mechanical testing was performed of implants and scaffolds after interaction and compared to non-tested devices. Particulate analysis was performed on fluid collected from the bench apparatus. Results Scaffold-tissue capsules show surface characteristics similar to native tissue capsules, indicating complete integration at 4-weeks. After 12-week benchtop loading, mechanical properties of scaffolds and implants were comparable to controls and met standard specifications for new devices. Particulates were below detection limits. Conclusions This preclinical study evaluated early scaffold–implant interaction during the period of maximal direct polymer contact and assessed mechanical interactions under worst-case simulated conditions. By 4 weeks in animals, tissue integration limits direct polymer–implant contact. After 12 weeks on the bench, no compromise of implant or scaffold mechanical integrity or detectable particulates were observed under the tested conditions. These findings provide preliminary data and do not address long-term effects.