Micro-textured silicone-based implant fabrication using electrospun fibers as a sacrificial template to suppress fibrous capsule formation.

Conventionally, macro-textured surfaces comprising several hundred micrometer-sized patterns are used to minimize silicone-based breast implant complications, including capsular contracture. However, because of the recent cases of breast implant-associated anaplastic large cell lymphoma from macro-textured implants, there is a strong demand for nano- or micro-textured silicone implants with dimensions smaller than sub-micrometers. Herein, we propose a simple and cost-effective topographical surface modification strategy for silicone-based implants. Several hundred nanometer to sub-micrometer wide groove-type micro-textures were fabricated on a polydimethylsiloxane surface using electrospun polyvinylpyrrolidone fibers as a sacrificial template. The aligned and randomly oriented micro-textures were prepared by controlling the electrospun fiber orientation. In vitro experiments demonstrated that the micro-textured polydimethylsiloxane was cytocompatible and suppressed differentiation of fibroblasts into myofibroblasts. Importantly, the aligned micro-texture promoted the polarization of macrophages into the anti-inflammatory M2 phenotype. Long-term in vivo studies established that the micro-textures potently suppressed various factors affecting foreign body reactions by downregulating profibrotic cytokine gene expression and reducing the fibroblast and myofibroblast counts, the cells playing important roles in the immune response. Thus, the thickness and collagen density of fibrous capsules were decreased, demonstrating that the micro-textured surface effectively inhibited capsular contracture. Although the aligned micro-textures contributed to the polarization of macrophages to the M2 phenotype both in vitro and in vivo, foreign body reaction by both the aligned and randomly oriented micro-textures are similar.