Materials, design, manufacturing, and regulatory status of alloplastic temporomandibular joint prostheses: insights from Brazil.

International journal of oral and maxillofacial surgery Pub Date : 2025-05-23 DOI:10.1016/j.ijom.2025.05.002

R A G Pierri, L G Mercuri, D S Cassano, L R da Cunha, J R Gonçalves

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Abstract

End-stage temporomandibular joint (TMJ) disorders are commonly managed with alloplastic joint replacement prostheses (TMJR). However, concerns about the quality of TMJR materials, their design, and manufacturing persist in the literature. A large variety of TMJR systems are available in Brazil; however only two, Zimmer/Biomet and Stryker/TMJ Concepts, are supported by long-term safety and effectiveness studies. Despite the lack of such studies, various TMJR devices are registered with Anvisa, the Brazilian Health Regulatory Agency, and are clinically available. This study identified 11 TMJR systems available on the Brazilian market, nine of which are produced domestically. None of these Brazilian-manufactured systems have published laboratory, pre-clinical testing, or follow-up data, despite all being on the market for over 5 years. Using the Brazilian TMJR experience as an example, the aim of this narrative review is to urge that these elements are addressed by developers, manufacturers, and regulatory bodies worldwide for currently available TMJRs and future TMJRs, before they reach the marketplace.

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同种异体颞下颌关节假体的材料、设计、制造和监管状况：来自巴西的见解。

终末期颞下颌关节（TMJ）疾病通常采用同种异体关节置换假体（TMJR）进行治疗。然而，对TMJR材料的质量、设计和制造的关注仍然存在于文献中。巴西有各种各样的TMJR系统；然而，只有Zimmer/Biomet和Stryker/TMJ Concepts两家公司获得了长期安全性和有效性研究的支持。尽管缺乏此类研究，但各种TMJR装置已在巴西卫生监管机构Anvisa注册，并可用于临床。本研究确定了巴西市场上可用的11个TMJR系统，其中9个是国内生产的。这些巴西制造的系统均未公布实验室、临床前测试或随访数据，尽管它们都已上市超过5年。以巴西TMJR的经验为例，本文的目的是敦促世界各地的开发人员、制造商和监管机构在当前可用的TMJR和未来的TMJR进入市场之前解决这些问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International journal of oral and maxillofacial surgery

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