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Abstract Some textured silicone breast implants with high average surface roughness (‘macrotextured’) have been associated with a rare cancer of the immune system, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Silicone elastomer wear debris may lead to chronic inflammation, a key step in the development of this cancer. Here, we model the generation and release of silicone wear debris in the case of a folded implant-implant (‘shell-shell’) sliding interface for three different types of implants, characterized by their surface roughness. The ‘smooth’ implant shell with the lowest average surface roughness tested (R a = 2.7 ± 0.6 μ m) resulted in average friction coefficients of μ avg = 0.46 ± 0.11 across 1,000 mm of sliding distance and generated 1,304 particles with an average particle diameter of D avg = 8.3 ± 13.1 μ m. The ‘microtextured’ implant shell (R a = 32 ± 7.0 μ m) exhibited μ avg = 1.20 ± 0.10 and generated 2,730 particles with D avg = 4.7 ± 9.1 μ m. The ‘macrotextured’ implant shell (R a = 80 ± 10 μ m) exhibited the highest friction coefficients, μ avg = 2.82 ± 0.15 and the greatest number of wear debris particles, 11,699, with an average particle size of D avg = 5.3 ± 3.3 μ m. Our data may provide guidance for the design of silicone breast implants with lower surface roughness, lower friction, and smaller quantities of wear debris. 

Silicone elastomer medical implants are ubiquitous in medicine, particularly for breast augmentation. However, when these devices are placed within the body, disruption of the natural biological interfaces occurs, which significantly changes the native energy-dissipation mechanisms of living systems. These new interfaces can introduce non-physiological contact pressures and tribological conditions that provoke inflammation and soft tissue damage. Despite their significance, the biotribological properties of implant-tissue and implant-extracellular matrix (ECM) interfaces remain poorly understood. Here, we developed an in vitro model of soft tissue damage using a custom-built in situ biotribometer mounted onto a confocal microscope. Sections of commercially-available silicone breast implants with distinct and clinically relevant surface roughness ([Formula: see text]m, [Formula: see text]m, and [Formula: see text]m) were mounted to spherically-capped hydrogel probes and slid against collagen-coated hydrogel surfaces as well as healthy breast epithelial (MCF10A) cell monolayers to model implant-ECM and implant-tissue interfaces. In contrast to the “smooth” silicone implants ([Formula: see text]m), we demonstrate that the “microtextured” silicone implant ([Formula: see text]m) induced higher frictional shear stress ([Formula: see text]  Pa), which led to greater collagen removal and cell rupture/delamination. Our studies may provide insights into post-implantation tribological interactions between silicone breast implants and soft tissues.