Abstract
The purpose of this study is to develop the guideline of the physicochemical and mechanical properties evaluation for silicone gel filled breast implants. First of all, the use and development status for silicone gel filled breast implants were investigated, and then, standard and criteria about performance evaluation established by the international organizations such as ASTM, FDA guidance and ISO were examined. To evaluate the mechanical properties, data research and testing for breaking strength, elongation, tensile set, joint intensity, silicone gel cohesion, weight loss from heating, static rupture resistance, impact resistance test, fatigue test, and gel bleed were performed. On the other hand, to evaluate the physicochemical properties, volatile matter, extent of cross linking, heavy metals, and extractable were analyzed. In this study, results for general function, mechanical properties and physicochemical properties were examined and reviewed for the accordance with international standard, and objective and standardized guideline was provided.
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