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

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.