Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.
PMID：42674147 ·
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摘要
Permanent dermal fillers based on poly (methyl methacrylate) (PMMA) offer durable aesthetic correction but introduce lifelong patient risk due to their non-resorbable nature. This risk profile raises the question of whether existing regulatory frameworks adequately address the material determinants of long-term biocompatibility. This study presents a comparative analysis of publicly accessible regulatory documentation governing PMMA dermal fillers across three major jurisdictions: the U.S. Food
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