Análise de falhas de implantes cirúrgicos no brasil: a necessidade de uma regulamentação adequada retrieval and failure analysis of surgical implants in brazil: the need for proper regulation

1347
Cad. Saúde Pública, Rio de Janeiro, 18(5):1347-1358, set-out, 2002
ARTIGO ARTICLE
Análise de falhas de implantes cirúrgicos no Brasil: a necessidade de uma regulamentação adequada
Retrieval and failure analysis of surgical implants in Brazil: the need for proper regulation
1 Laboratório de
Metalografia e Análise de Falhas, Instituto de
Pesquisas Tecnológicas do Estado de São Paulo.
Rua Professor Almeida Prado
532, São Paulo, SP
05508-901, Brasil. [e-mail] 2 Laboratório de Mecânica da Fratura e Integridade
Estrutural, Instituto de
Pesquisas Tecnológicas do Estado de São Paulo.
Rua Professor Almeida Prado
532, São Paulo, SP
05508-901, Brasil. [e-mail], Cesar R. de Farias Azevedo 1
Eduardo Hippert Jr. 2
Abstract This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis, Instituto de Pesquisas Tecnológicas (IPT), in Brazil. Failures with two stainless steel femoral compression plates, one stainless steel femoral nail plate, one Ti-6Al-4V alloy maxillary reconstruction plate, and five Nitinol wires were investigated.
The results showed that the implants were not in accordance with ISO standards and presented evidence of corrosion-assisted fracture. Furthermore, some of the implants presented manufacturing/processing defects which also contributed to their premature failure. Implantation of materials that are not biocompatible may cause several types of adverse effects in the human body and lead to premature implant failure. A review of prevailing health legislation is needed in Brazil, along with the adoption of regulatory mechanisms to assure the quality of surgical implants on the market, providing for compulsory procedures in the reporting and investigation of surgical implants which have failed in service.
Key words Protheses and Implants; Prosthesis Failure; Legislation
Resumo Este artigo apresenta alguns casos de análise