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PubMed

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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JournalRegulatory toxicology and pharmacology : RTP
Year
PMID42674147

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

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