title: 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.
authors.affiliation: Centre for Forensic Science, University of Northumbria at Newcastle, Northumberland Building, Northumberland Road, Newcastle upon Tyne, NE1 8ST, UK. matthias.wienroth@northumbria.ac.uk.
authors.forename: Matthias
authors.initials: M
authors.lastname: Wienroth
authors.affiliation: Policy, Ethics & Life Sciences Research Centre, Newcastle University, Claremont Bridge, Claremont Road, Newcastle upon Tyne, NE1 7RU, UK. pauline.mccormack@ncl.ac.uk.
authors.forename: Pauline
authors.initials: P
authors.lastname: McCormack
authors.affiliation: School of Mechanical and Systems Engineering, Newcastle University, Stephenson Building, Claremont Road, Newcastle upon Tyne, NE1 7RU, UK. thomas.joyce@ncl.ac.uk.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Joyce
keywords: DePuy ASR; Governance; Medical device; Medical implant failure; Metal-on-metal hips; Precautionary principle