The expertise and advice of Newcastle University academics could result in new, tougher laws on the regulation of medical implants.
In the wake of problems with metal on metal hip implants, which were investigated by Professor Tom Joyce and Dr Pauline McCormack, and then the PIP breast implant scandal, the Government launched an investigation into how implants are regulated.
Professor Joyce and Dr McCormack of Newcastle University, were asked to give evidence to the Science and Technology Select Committee and their recommendations have been accepted by the committee in its report, released today. The report could lead to new laws if Parliament gives approval.
Currently there is little transparency over how medical implants were approved for use, the results of any pre-clinical experiments and who approved them. Also failed implants are often just thrown away so there is no chance to learn why they may have failed. This was deemed unacceptable by Prof Joyce and Dr McCormack and the Select Committee agreed.
Professor Tom Joyce, Professor of Orthopaedic Engineering at Newcastle University said: “When we were looking at the metal on metal hip implants it became clear that the process of approving medical implants is murky to say the least. This was something that was causing unnecessary suffering to patients and adding cost to the NHS.
“Estimates suggest as much as £250,000,000 every year could be being wasted as patients need to have joints re-implanted because they fail. It seems ridiculous that we are not studying these failed devices to learn more about them, or making the approval process more transparent.
“The select committee agrees with several of our findings. If this report is accepted by Parliament and made into law it has the potential to help millions of people if other countries follow our lead.”
Newcastle University’s bioengineering team led by Professor Joyce began investigating the problem of metal hips as far back as 2008 and have collaborated with the PEALS (Policy Ethics and Life Sciences) research centre to explore the concerns of patients.
All-metal hips have a higher than anticipated failure rate and rubbing between the ball and cup can cause metal to break off, seeping into tissue and causing complications.
Half of the all-metal hips fail after about five years, when they should last for between 15-20 years.
Among the findings of the report, written by MPs, it states: “Greater transparency would improve public confidence in the system and support decision-making by patients and healthcare professionals. We are disappointed that there is a lack of transparency in the current regulatory system and we urge the UK Government to take a lead in increasing transparency.”
The report also states: “Examination of explanted joints that have failed or caused problems in the body is one of the most valuable sources of data about how and why implants fail-they can be thought of as the 'black box'. We call for the conservation and analysis of explanted joints to be made mandatory as part of the NJR (National Joint Registry) reporting procedure.”
published on: 1 November 2012