SAFE Silicone IMPLANTS: Towards Zero-migrating, Zero-impact Silicone Products – SAFE-IMPLANT

Since the last two decades, use of silicone implants have expanded significantly especially in the field of plastic surgery. Most silicone implants are composed of a solid cross-linked silicone elastomer shell and a liquid gel filling containing a mixture of low-molecular-weight silicone fluids. Regardless of the implant’s location and type, a broad spectrum of chronic inflammatory-related diseases has been observed after implantation. Even without sign of rupture, implant biocompatibility is challenged by the presence of silicone liquid droplets and solid debris diffusing to the periprosthetic tissue, a fibrotic capsule surrounding the implant as a result of the foreign body reaction. Evidence supports the major role played by permeation-driven flow of silicone and platinum (Pt) catalyst species through the shell membrane. The PRCE ANR project SAFE-IMPLANT will achieve a clear understanding of which silicone and Pt species are able to permeate through a silicone elastomer membrane (shell) and their specific immune response. Through this knowledge-based approach, we will develop a new generation gel-filled silicone implant preventing the leaching of toxic species (zero-migration) into the tissue or releasing only products with minimal inflammatory impact (zero-impact). Our inter-disciplinary research consortium consists of the Institut Européen des Membranes (IEM) at Montpellier and the Institut de Science des Matériaux de Mulhouse (IS2M) with recognized expertise in membrane permeation and cellular interactions of silicone material, respectively. They will work in collaboration with the research-intensive SME STATICE at Besançon specialized in the engineering and design of medical silicone devices.