Many patients have suffered “needlessly” because of a slow reaction to faulty metal-on-metal hip implants, MPs have said.
The Science and Technology Committee said it appears the Medicines and Healthcare products Regulatory Agency (MHRA) was “slow in responding” to data which emerged about the faulty implants.
The committee said it was “disappointing” that problems were picked up several years before the worldwide recall of DePuy ASR metal-on-metal hip implants.
In 2010, the MHRA issued a product recall for the artificial hips after concerns were raised that if the replacements wear down, metal particles can be released and react with the soft tissue surrounding the joint.
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 changes.
The problems were noticed by Australian officials in 2007, and the implants were removed from the Australian market in December 2009, but the worldwide recall was not issued until August 2010.
The committee’s report on the Regulation of Medical Implants in the EU and UK states: “The European Commission and UK Government must improve the speed with which information from adverse incident reporting abroad is handled and acted upon.
“We are satisfied that the commission intends to propose greater co-ordination across EU member states when adverse incidents are reported.
“However, global co-ordination and collaboration are also essential.
“It is disappointing that problems with metal-on-metal hip implants were picked up several years before the worldwide recall and it appears that the MHRA was slow in responding to data emerging from Australia.
“Because of that delay, many patients have suffered needlessly.”
The Altogether Hip Patient Support Group, for people fitted with such implants, told the committee that the MHRA did not prioritise patient wellbeing.
Members of the group told the committee: “The MHRA seems to be a totally ineffective body working on behalf of the corporations rather than patients.”
MPs recommended that the regulatory body should improve the transparency surrounding its committee which ensures that medical devices and equipment meet appropriate standards of safety.
“It is impossible to evaluate the performance of the MHRA’s Committee on the Safety of Devices (CSD) when its work is kept secret,” the report states.
Committee chairman Andrew Miller added: “Thousands of patients use medical implants in the UK every day without problem.
“When things do go wrong with implants, however, it can ruin lives – as the complications with metal-on-metal hip replacements have sadly shown.
“We were shocked to hear about the practice of so-called ‘forum shopping’, where manufacturers shop around for the least stringent regulatory regimes in which to get their medical implants approved.
Mr Miller concluded: “Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using.”