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Retrieval and analysis of surgical implants in Brazil: The need for proper regulation

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Abstract

This paper summarizes several cases of metallurgical failure analysis of surgical implants conducted at the Laboratory of Failure Analysis of IPT, in Brazil. Investigation revealed that most of the samples were not in accordance with ISO standards and presented evidence of corrosion assisted fracture. Additionally, some components were found to contain fabrication/processing defects that contributed to premature failure. The implant of nonbiocompatible materials results in immeasurable damage to patients as well as losses for the public investment. It is proposed that local sanitary regulation agencies create mechanisms to avoid commercialization of surgical implants that are not in accordance with standards and adopt the practice of retrieval analysis of failed implants. This would protect the public health by identifying and preventing the main causes of failure in surgical implants.

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  1. Laboratory for Failure Analysis, Instituto de Pesquisas Tecnológicas do Estado de São Paulo, Post Office Box 0141, 01064-970, São Paulo, Brazil

    C. R. F. Azevedo & E. Hippert

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  1. C. R. F. Azevedo
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  2. E. Hippert
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Azevedo, C.R.F., Hippert, E. Retrieval and analysis of surgical implants in Brazil: The need for proper regulation. Practical Failure Analysis 1, 53–61 (2001). https://doi.org/10.1007/BF02715380

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