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CC BY 4.0 · Revista Brasileira de Cirurgia Plástica (RBCP) – Brazilian Journal of Plastic Surgery 2025; 40: s00451809393
DOI: 10.1055/s-0045-1809393
Artigo Original

Avaliação da ruptura assintomática de implantes mamários preenchidos com gel de silicone Silimed

Article in several languages: português | English
Wanda Elizabeth Massiere-y-Corrêa 
1   Especialidade de Cirurgia Plástica, Clínica Particular, Rio de Janeiro, RJ, Brasil
› Author Affiliations
Suporte Financeiro

A autora declara que este estudo recebeu suporte financeiro da Silimed.


Ensaio Clínico

NCT02206282.


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Resumo

Introdução

O aumento mamário é uma cirurgia estética praticada desde 1895, e que ganhou popularidade na década de 1960 com o surgimento dos implantes de silicone. Embora seja um procedimento comum, podem ocorrer complicações, como a ruptura dos implantes. A ruptura “silenciosa” é especialmente preocupante, pois não apresenta sintomas e requer monitoramento cuidadoso. A United States Food and Drug Administration (FDA) indica os exames de ultrassonografia (USG) ou ressonância magnética (RM) para identificar a ruptura silenciosa.

Objetivo

Avaliar a taxa de rupturas assintomáticas em pacientes com implantes mamários de envelope externo lisos e texturizados da marca Silimed (Silimed Indústria de Implantes Ltda.) por meio de RM.

Materiais e Métodos

Foram selecionados 97 cirurgiões de diversas cidades brasileiras com prontuários de pacientes que utilizavam implantes Silimed. Foram excluídas pacientes com implantes de outros fabricantes, gestantes, e aquelas com contraindicações para a RM. As pacientes selecionadas realizaram exames clínicos e RM, e as imagens foram analisadas por radiologistas independentes. Suspeitas de ruptura foram confirmadas cirurgicamente.

Resultados

Entre as 161 pacientes avaliadas, 2 (0,63%) apresentaram suspeita de ruptura confirmada cirurgicamente, ambas com 9 anos de implantação: uma com implante liso e outra, com texturizado. A maioria dos implantes foi considerada íntegra: 99,67% dos texturizados e 95,24% dos lisos.

Conclusão

Este estudo contribui para o conhecimento científico sobre rupturas de implantes mamários, e sugere que os implantes Silimed são seguros. A taxa de ruptura assintomática em implantes com 5 a 10 anos de implantação foi baixa.

Palavras-chave

eventos adversos - gel de silicone - implantes mamários - ruptura assintomática - ruptura do implante

Número do Comitê de Ética

174.


Estudo realizado no Hospital Pró-Cardíaco, Rio de Janeiro, RJ. Brasil.




Publication History

Received: 10 November 2023

Accepted: 24 March 2025

Article published online:
20 June 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/)

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Bibliographical Record
Wanda Elizabeth Massiere-y-Corrêa. Avaliação da ruptura assintomática de implantes mamários preenchidos com gel de silicone Silimed. Revista Brasileira de Cirurgia Plástica (RBCP) – Brazilian Journal of Plastic Surgery 2025; 40: s00451809393.
DOI: 10.1055/s-0045-1809393
 

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