Regulating human implant technologies in Europe: Understanding the new era in medical device regulating
Faulkner, A. and Kent, J. (2002) Regulating human implant technologies in Europe: Understanding the new era in medical device regulating. Health, Risk & Society, 4 (2). pp. 189-209. ISSN 1369-8575
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Publisher's URL: http://dx.doi.org/10.1080/13698570220137060
It has been suggested that we are entering a new era in medical device regulation in Europe. This paper discusses the implementation of the European Medical Devices Directive (EMDD) in EU member states with a particular focus on the UK. Case studies are then presented of two models of implant technologies--Trilucent breast implants and the 3M Capital hip prosthesis. Both have been withdrawn from the marketplace recently in controversial circumstances. Different aspects of regulatory activity are outlined with a bearing upon benefits and safety from national health services' and consumers' perspectives, and a number of issues concerned with the ability of regulatory mechanisms and practices to serve public health and safety are identified. Our analysis of the case studies draws parallels with studies of drug regulation, and explores the construction of risk and public participation in policy making. We argue that there are weaknesses in the regulation of medical devices and that commercial interests have dominated regulatory policy. Our case studies, however, suggest a shift towards a more user-oriented shaping of regulation.