Precaution, governance and the failure of medical implants: the ASR((TM)) hip in the UK

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.

Keywords: DePuy ASR; Governance; Medical device; Medical implant failure; Metal-on-metal hips; Precautionary principle.

Figure 1

DePuy ASR ™ resurfacing hip (note the small femoral stem right). To the left is the acetabular cup and to the right is the single-piece femoral component.

Figure 2

DePuy ASR ™ XL total hip replacement with conventional femoral stem (shown above ruler). Femoral head is shown top left and the acetabular cup is shown top right.