Abstract
Hip implants have provided life-changing treatment, reducing pain and improving the mobility and independence of patients. Success has encouraged manufacturers to innovate and amend designs, engendering patient hopes in these devices. However, failures of medical implants do occur. The failure rate of the Articular Surface Replacement metal-on-metal hip system, implanted almost 100,000 times world-wide, has re-opened debate about appropriate and timely implant governance. As commercial interests, patient hopes, and devices’ governance converge in a socio-technical crisis, we analyse the responses of relevant governance stakeholders in the United Kingdom between 2007 and 2014. We argue that there has been a systemic failure of the governance system entrusted with the safety of patients fitted with medical implants. Commercial considerations of medical implants and the status quo of medical implant governance have been given priority over patient safety despite the availability of significant failure data in an example of uncertainty about what constitutes appropriate precautionary action.
Highlights
This paper examines a history of managing medical implant failure, the responses of key stakeholders in an emergent realisation of failure
By ‘failure’ we refer to guidelines by National Institute for Clinical Excellence (NICE) (National Institute for Health and Care Excellence) (2002) which stipulate a benchmark for hip implant revision of 10% at ten years, commonly translated to 1% per year of the life of the implanta
This paper attends to a later point in the process, and explores a question frequently articulated by patients dealing with the consequences of failed MoM hip implants (House of Commons Science and Technology Committee 2012): when data emerges indicating medical implant failure at an unacceptable level, who is responsible for responding to those data, for preventing harm to patients? By exploring the actions and rationales of key stakeholders we argue that there has been systemic failure of implant governance in the United Kingdom (UK)
Summary
This paper examines a history of managing medical implant failure, the responses of key stakeholders in an emergent realisation of failure. Despite these significant events the modes of governance of medical implants – professional, notifying and regulatory – were again shown to be lacking by the recent global failures of the DePuy ASRTM hip, while problems with MoM hips in general continue to be noted (Heneghan et al 2012).
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