Systematic biocompatibility assessment of 4-µm surface silicone implants.

Abstract

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 wit