Frustrated Patients Demand Answers Over MHRA’s ‘Failure To Act’ On Unregulated ‘Mix-Match’ Hip Implants

Lawyers Reveal Evidence Finds Concerns Raised To Regulator In 2007

09.11.2014

Lawyers acting for patients left with serious health problems as a result of being fitted with unregulated ‘mix-match’ hip replacements have urged that the regulatory system which governs the products is urgently reviewed, after it was revealed that a warning about such practices should have been issued to healthcare providers up to two years before they underwent surgery.

Irwin Mitchell’s specialist Product Liability team are taking legal action against private and NHS hospitals on behalf of a number of people who suffered complications with hip devices found to be built by surgeons from components produced by different manufacturers.

Such practices render the regulatory approval given to the original devices from which the components void, meaning the new ‘mix-match’ device has not been subject to the required testing prior to use.

Staff within the Medicines and Healthcare products Regulatory Authority (MHRA) suggested issuing guidance to healthcare providers advising that the use of such off-label, mix-match devices was unacceptable as far back as 2007, yet Irwin Mitchell is representing some clients who were fitted with such devices in 2008 and 2009 and there are concerns that even now patients may still be given mix-match replacements.

The national law firm, which represents hundreds of patients affected by problems with metal-on-metal hip implants and other defective medical devices, have joined forces with patients to call for urgent action to be taken to determine why procedures continued after 2007 and whether the current regulatory framework is sufficient to protect patients from further harm.

Kevin Timms, a legal expert at Irwin Mitchell representing the patients injured as a result of ‘mix-match’ hip implants, said: “The potential risks and dangers of metal-on-metal hip replacement devices have been common knowledge for a number of years, but the ‘mix-match’ issue is a new and shocking scandal in relation to the issue.

“The cases have only come to light after patients have contacted us for help regarding problems with their implants, with a subsequent review of medical records highlighting that they have been fitted with an unregulated device built from components which are not designed to be used together.

“It has now come to our attention that this issue was raised by the MHRA as far back as 2007, with calls for clinicians to be advised on the topic. But is seems that whilst the issue was talked about, no action was taken to educate healthcare professionals on the risks and implement guidance on alternative options.

"We are also aware that some hospitals have policies to regulate the use of off-label devices whereas other may not. Where policies are in place, it is clear those policies in many instances have not been adhered to. This is why it is of considerable concern that some of our clients were fitted with such devices in the years after this and we are worried that patients now could still be at risk.

“Our clients have suffered a huge amount of physical and emotional distress after being fitted with these devices and clear questions have been raised regarding whether the MHRA is adequately using its powers to ensure that patients are properly protected from harm – and whether medical professionals are listening to the concerns being raised by the regulator.”

CASE STUDIES

Keith Humphris, 56, from Cheltenham, was fitted with two hip replacement devices at Cheltenham Hospital in 2008 and after suffering serious complications over the following years he contacted Irwin Mitchell for help regarding the issue.

He said: “The problems I’ve suffered with the hip implants have had a massive impact on my life. I’ve had to give up managing my farm shop and also had to let go of the dream to launch my own gardening and DIY business. My life has been turned upside down.

“I was absolutely stunned when investigations revealed that the regulatory body looking after this area were talking about this issue before my procedure – it really does make you wonder whether enough effective action is being taken to protect patients from potentially defective products.

“The damage has been done for me now, but improvements must be made to prevent other suffering like I have.”

Laurence Tilley was fitted with a ‘mix-match’ hip replacement device in 2009 by Sussex Orthopaedic NHS Treatment Centre and has seen his life turned upside down in the five years since the procedure.

The 59-year-old from Hassocks in West Sussex recalls: “I was working as the director of a marketing company at the time of the operation, but had to give that up in 2010 as the pain I was suffering meant it was incredibly difficult for me to be mobile and ultimately get into the office in London.

“Since then I’ve tried to get new ventures up and running to limited success. The issues I’ve suffered have caused more than physical pain, but psychological and emotional stress too.

“I’m appalled to think that all of this has happened after I was fitted with a hip device which isn’t even regulated – and that the issue was raised by regulators several years before mine was fitted. I want to know how this has been allowed to happen and what is being done to stop others facing the same difficulties I have.”

If you or a loved one has suffered due to "mix and match" metal-on-hip implants, our expert personal injury solicitors could help you claim compensation. View our “Mix And Match” Metal-On-Metal Hip Implants Claims page for more information.