Questions Raised Over Medical Device Regulation As Over 15,000 Patients Affected

Leading product liability and medical negligence lawyers have welcomed a report advising the NHS to stop using most metal-on-metal hip implants.

Irwin Mitchell currently represents over 275 patients who have been affected by metal-on-metal hip replacements. These implants have been found to have a higher failure rate than other types of hip implant, and this is likely to affect thousands of people.

A report drawn up by the National Institute for Health and Care Excellence (NICE), suggests that only hip implants with a failure rate of less than 5% at 10 years should be used in NHS hospitals. The current NICE standard is for a failure rate of no more than 10% at 10 years. The proposed new standard would mean that 5 metal-on-metal implants currently available could no longer be used by the NHS.

Concerns have also been raised about metal-on-metal implants releasing toxic metal particles which get into the blood stream of patients as the joints wear, causing damage to muscle and tissues.

The most well-known device, the ASR, manufactured by DePuy, part of Johnson and Johnson,  was recalled in 2010 after it was found that 13% failed within five years and almost a quarter of people required revision surgery in the same timeframe. An investigation found that failure rates after nine years were around 43%.

Tim Annett, a specialist product liability and medical negligence lawyer at Irwin Mitchell, said:

Expert Opinion

We have seen firsthand how often the metal-on-metal devices can fail. So many patients’ lives are being affected and although there has been action previously to recall some devices, questions must be asked about how thoroughly others have been investigated.

“When they were introduced these devices were supposed to be better for younger more active patients but some of our clients have been left struggling to walk and with serious health problems because of toxic metal debris from metal-on-metal hips.

“Many patients in the UK who have had hip replacement surgery in the last few years will be worried and it is important that people who have been given a metal-on-metal implant speak to their doctor or surgeon as soon as possible to find out if their treatment needs to be reviewed. Current guidance is that people with metal-on-metal implants should be reviewed annually by their doctor.

“News of the NICE report is welcome, but it will not help the thousands of people who have already had the devices fitted. Patient safety must by the priority of all those involved in healthcare and in production of medical devices.

“The problems seen with the metal-on-metal hip implants and also other cases with large numbers affected such as the PIP breast implant scandal raise serious questions about how dangerous medical devices and pharmaceuticals make it onto the market. There are strong reasons to argue that the regulation of medical devices needs to be reviewed to ensure that the safety of the public is paramount.” Tim Annett - Partner

The metal-on-metal implants found to have failure rates above the new level are the following resurfacing models: the Finsbury Adept; Corin Cormet 2000; Zimmer Durom; Biomet ReCap Magnum; and Wright Conserve Plus.

A sixth device, the DePuy Corail/Pinnacle total hip replacement using ceramic on metal, also failed to meet the standard.

Our experienced personal injury claims team will provide you with free initial advice on your compensation claim if you have suffered as the result of metal-on-hip implants. View our Metal-On-Metal Hip Implants Claims page for more information.