Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.
PMID: 42674147 ·
Evilasio Anisio Costa Filho, Albaniza Alves Tavares, Antonio Gilson Barbosa de Lima, Victhor Alexandre Vilarins Cardoso da Silva, Stela Candioto Melchior, Maria Glória Vicente, Marcus Vinicius Lia Fook, Suédina Maria de Lima Silva
Abstract
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 a
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