Implants are widely used across the NHS, yet for many devices there is limited robust evidence about their long-term outcomes or value for money. When available, clinical trials are often too small to detect rare or delayed complications and may exclude people with complex health needs or from certain minority backgrounds.
‘Recent reports have highlighted the need for stronger systems to monitor implant safety,’ said Daniel Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology at NDORMS. ‘Our study will develop and test a framework to improve how commonly used implants are monitored and evaluated in the NHS, particularly for patients with complex health needs and those from underserved communities.’
Funded by a NIHR Programme Grant for Applied Research (PGfAR), the programme titled Making Implants safer and more Cost-Effective for patients and the National Health Service (MICE), will firstly identify the most useful healthcare data sources, review the best analytical methods, and apply these approaches to selected examples of implant use.
A collaboration between NDORMS at the University of Oxford, the University of Bristol and Queen Mary University of London, the team will evaluate four types of implants used in different NHS settings: heart valve replacements, hip implants following hip fracture, vaginal mesh, and endoprostheses used in emergency heart surgery for aortic dissection.
They will also assess whether different implant options for heart valve surgery and hip fracture provide good value for money for the NHS.
In addition, the research team will work with patients, clinicians and regulators to prioritise two further implant types and test the framework in these areas.
‘Patient and public involvement is essential and embedded throughout the programme,’ said Anna Saura-Lazaro, Senior Researcher in Clinical Epidemiology and Real World Evidence at NDORMS. ‘A patient advisory group has already contributed to shaping the research questions and study design and has identified priorities for improving patient experience and support. They bring perspectives that cannot be captured in routine data alone, including what outcomes matter most in everyday life, how complications affect families and carers, and where communication and ongoing care can fall short.’
Throughout the project, the team will continue to work closely with patients and carers to ensure that the research reflects lived experience and supports shared decision-making.
The findings from the MICE programme will strengthen the evidence base for implants and improve how they are monitored after introduction into care, leading to better outcomes for patients and more informed decision-making across the NHS.