Systematic Biocompatibility Assessment of 4-µm Surface Silicone Implants

• There is a lack of published evidence on the biocompatibility of breast implants. • For the first time, results of ISO 10993 studies of a breast implant are presented. • These results can aid in the decision-making process of patients and surgeons. Biocompatibility refers to a medical device’s ability to perform its intended function without provoking adverse biological responses. Although global regulatory agencies have introduced measures to improve risk communication about breast implants, there remains a lack of published preclinical data evaluating their biocompatibility. To enhance transparency and patient education regarding implant safety, this study aims to characterize the biocompatibility profile of a silicone breast implant with a 4-micron surface roughness shell by evaluating its performance across ISO 10993 biological endpoints relevant to current safety concerns and to make this data publicly available. Launched in 2010, it is now available in over 90 countries, including a recent approval by the U.S. Food and Drug Administration for breast augmentation. Genotoxicity testing revealed no mutagenic effects. A 26-week in vivo carcinogenicity study in Tg.rasH2 mice showed no evidence of carcinogenic potential. Immunophenotyping of peripheral blood and spleen indicated no signs of immunotoxicity. The device was also found to be non-cytotoxic, non-sensitizing, non-irritating, and non-toxic following acute, subacute, and chronic exposure. Furthermore, it demonstrated no pyrogenic or hemolytic activity and no evidence of reproductive or developmental toxicity. This is, to our knowledge, the first report of detailed results of ISO 10993-1 biocompatibility tests for a silicone breast implant. Collectively, these findings provide robust scientific support for the biocompatibility of 4-micron average roughness shell surface silicone implants. Ongoing research and transparent reporting will continue to inform patients and clinicians, support clinical decision-making, and strengthen public confidence in the safety of these devices.