How much does a Medical and Healthcare Products Regulatory Agency medical device alert for metal-on-metal hip arthroplasty patients really cost?

Hip Int. 2022 Jul;32(4):493-500. doi: 10.1177/1120700020983297. Epub 2021 Jan 14.

Abstract

Background: Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However, concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in "at-risk" Birmingham Hip Resurfacing (BHR) patients; and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed without patient recall.

Methods: All BHR patients eligible for the 2015 MHRA recall (all females, and males with head sizes ⩽46 mm, regardless of symptoms) at one centre were invited for review (hips = 707; patients = 593). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data.

Results: The surveillance cost £105,921.79 (range £147.76-£257.50/patient). Radiographs (£39,598) and nurse practitioner time/assistance (£23,618) accounted for 60% of overall costs. 31 hips had ARMD on imaging (12 revised; 19 under surveillance). All revisions were symptomatic. 7 hips with ARMD under surveillance were asymptomatic and remain under regular review. The number needed to treat to avoid missing one asymptomatic ARMD case was 101 patients, representing a cost of £18,041 to avoid one asymptomatic case.

Conclusions: Implementing MHRA surveillance for "at-risk" BHR patients was extremely costly. The risk of asymptomatic ARMD was low with the BHR (1%), suggesting recommended follow-up in asymptomatic patients is not cost efficient. This raises concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for metal-on-metal hip patients.

Keywords: Cost; hip arthroplasty; metal-on-metal; revision surgery; surveillance.

MeSH terms

  • Arthroplasty, Replacement, Hip* / adverse effects
  • Delivery of Health Care
  • Female
  • Hip Prosthesis* / adverse effects
  • Humans
  • Male
  • Metal-on-Metal Joint Prostheses* / adverse effects
  • Metals / adverse effects
  • Prosthesis Design
  • Prosthesis Failure
  • Reoperation

Substances

  • Metals