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

Wienroth, Matthias, McCormack, Pauline and Joyce, Thomas (2014) Precaution, governance and the failure of medical implants: the ASR(TM) hip in the UK. Life Sciences Society and Policy, 10 (1). p. 19. ISSN 2195-7819

[img]
Preview
PDF (Article (available under Creative Commons Attribution Licence 4.0) )
Wienroth_et_al_-_2014_-_Precaution_governance_and_the_failure_of_medical_devices.pdf - Published Version

Download (1MB) | Preview
Official URL: http://dx.doi.org/10.1186/s40504-014-0019-2

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.

Item Type: Article
Additional Information: Creative Commons Attribution Licence 4.0 http://creativecommons.org/licenses/by/4.0/
Uncontrolled Keywords: medical implant failure, medical device, governance, precautionary principle, DePuy ASR, metal-on-metal hips
Subjects: B800 Medical Technology
L300 Sociology
L900 Others in Social studies
Department: Faculties > Health and Life Sciences > School of Life Sciences > Applied Sciences
Related URLs:
Depositing User: Matthias Wienroth
Date Deposited: 01 Dec 2014 11:50
Last Modified: 11 May 2017 12:12
URI: http://nrl.northumbria.ac.uk/id/eprint/18341

Actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics


Policies: NRL Policies | NRL University Deposit Policy | NRL Deposit Licence