A committee of MPs has criticised the Medicines and Healthcare products Regulatory Agency (MHRA) for reacting too slowly to data from Australia on faulty metal-on-metal hip implants, claiming that that many patients suffered needlessly as a result of the delay. As a result, the MPs have called for an urgent tightening of implant regulation.
Problems with DePuy's ASR hip replacement implant were first flagged up by Australian officials three years before a worldwide recall was issued. Tiny metal ions made up of cobalt and chromium are thought to break off from the implants and leak into the blood, with fears this leads to muscle and bone damage and neurological issues.
Several scandals have rocked the medical implant manufacturing industry in recent years, causing the government's Science and Technology Committee to review the regulation of implants in the UK and EU.
In the report, MPs recommend controls including unannounced spot-checks and audits of manufacturing facilities, the collection and publishing of more rigorous data on implant safety and a central registry for all implants. The Committee hope that these measures will speed up the process of recalling those devices causing problems that have slipped through the net.
The report also uncovered what MPs have described as a shocking practice by which implant manufacturers shop around Europe to find the most lax regulatory regimes within which to get products approved. According to the report, manufacturers are exploiting the differences between notified bodies, which award the relevant approval for medical implants.
If a product is rejected by one notified body, some manufacturers then approach another only to see the implant pass the required standards and get approval for use. The Committee said that that these notified bodies should consider publishing details of all approaches by manufacturers whether complete or not to help stamp out the practice, dubbed 'forum shopping'.
Andrew Miller, chair of the Science and Technology Committee, said: “Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using.”
The process of approving a new implant for sale in Europe is far less stringent than that applied to new medicines and this needs to change, according to the report. Manufacturers and regulators often use data on equivalence – or similarity to an existing implant – when doing pre-market assessments rather than data collected through clinical trials of the new implant.
The MPs were “unimpressed” by this and called for manufacturers and regulators to publish more rigorous clinical data on the safety of new implants that can be scrutinised by others.
While collecting evidence for the report, a hip replacement support group told MPs that the MHRA “seems to be a totally ineffective body working on behalf of the corporations rather than patients”.
The Committee said that recent events, such as the withdrawal of PIP breast implants filled with industrial-grade silicone, had highlighted the need for frequent and unannounced spot-checks of medical implant manufacturers to help flag up and prevent similar problems occurring in the future.
MPs also backed proposals to audit manufacturers on an unannounced basis at least once a year.