Legal Experts Call For Tougher Regulation Of Medical Devices

Specialist lawyers representing a former gymnast and many others left in agony after they were fitted with Zimmer Durom metal-on-metal hip implants have called on regulatory authorities in the UK and Europe to demonstrate the steps which are being taken to improve standards and actively prevent more people suffering from the same issues in the future.

Irwin Mitchell’s specialist Product Liability team is representing a number of victims who have suffered significant complications following the use of the device.

The latest statistics from the National Joint Registry show that 9.45% of patients fitted with the device have had to undergo revision treatment within 7 years of its implantation. That is a relatively high failure rate by comparison to other hip prostheses and equates to several thousand people being affected by early failure.

The high failure rate is thought to be attributable to two particular design features. The metal on metal design has been proven to wear, releasing metal debris into surrounding tissue. This causes damage through a biological process known as ALVAL (aseptic lymphocyte-dominated vasculitis associated lesions). 

The durom acetabular, cup, which forms the socket part of the hip joint, is also susceptible to high rates of spontaneous loosening. This is at least in part the result of the design of the cup, which is difficult for surgeons to fit because of the presence of ’peripheral fins’.

Irwin Mitchell represents hundreds of people affected by problems with the Zimmer Durom and other metal-on-metal hip implants, including the ASR, which was manufactured by DePuy, part of Johnson and Johnson, and was subject to a recall in 2010.

The legal experts are now calling on regulatory authorities to outline what they are doing to ensure that issues with such devices can be identified earlier, with the ultimate aim of ensuring a better regulatory framework is in place which will protect patients from harm.

Matthew Newbould, a legal expert at Irwin Mitchell who is acting for victims of the Zimmer Durom metal-on-metal hip implants, said: “We have heard from a number of people who hoped that these devices would allow them to continue to enjoy active and independent lifestyles, only to be left with significant mobility issues and severe long-term pain as a result of complications with the devices.

“NICE (the National Institute of Clinical Excellence) guidelines state that only hip implants with a 10 year revision rate of 5% or under should be used on patients. The Zimmer Durom products had a rate of 9.45% at 7 years. The early failure rate is not the only issue; many of our clients have been left with irreparable damage to the joint because of the effect of metal debris.

“While our job description is to achieve redress for our clients, we also want regulatory bodies in the UK take a strong stance to ensure devices with a worrying track record on safety are never approved for use on patients ever again.

“Metal on metal hips are a classic example of a medical product released onto the market with limited testing and only a theoretical understanding of the likely outcome. These products have been a disastrous experiment which has left many innocent patients with lifelong injuries.

“The safety of patients must come first. This issue, like the PIP breast implant scandal,  raises serious questions  regarding the regulatory process which medical devices and pharmaceuticals must adhere to in order to reach the market – an area which we feel is ripe for review.

“We are actively campaigning for reform of a system which we feel is too accommodating to industry and not robust enough to properly protect the public from harm.”

CASE STUDY

Among Irwin Mitchell’s clients in relation to Zimmer Durom hip implants is Eileen Budd, 70, from Blandford in Dorset, a former gymnast and senior national coach in the sport who developed serious health problems as a result of the failure of the device fitted to her left hip.

Eileen recalls: “I first started having general problems with my hip in 2005 and was advised to have replacement surgery.

“The point of the surgery was to allow me to have an active life again, but after the operation, instead of seeing my mobility return to normal I suffered from months of pain and discomfort and could barely move.

“There would be times when the hip would lock up and cause me to fall. On one occasion my hip locked and I fell down the stairs, breaking my nose and knocking out several teeth”.

By 2009, a large lump had developed around Eileen’s hip, which her G.P. could not explain. By August, the lump was the size of a grapefruit. Eileen was unable to walk without support and was in constant pain. She was referred back to the Royal Gwent Hospital, where she was told that the lump was a tumour caused by the metal debris released from her Zimmer implant.

Eileen explains: “I was told that I would need surgery to replace the joint, but even that might not be successful, because if the damage was too severe it might not be possible to reconstruct the hip. I was absolutely devastated. The first surgery had been so traumatic that I was terrified of the thought of going through it again. I would have said no, but my surgeon told me there was simply no option, because the effects of the metal debris were not known and could potentially be life threatening.”

After the operation Eileen was told by her surgeon that her hip was one of the worst cases he had seen. A large amount of the bone was dead or had rotted away, and there was pus all around the joint. The operation had taken twice as long as a normal procedure and a lot of blood had to be transfused.

Over the next year, Eileen made a gradual recovery, with the help of physiotherapy and hydrotherapy. However, even now, she has not fully returned to fitness.

Eileen says: “Despite the second surgery, I still have weakness in my left leg. The muscles on that side have wasted away.  My calf and hip feel very stiff, and I can only walk for about 25 metres comfortably.

“The problems I’ve faced have brought my life to a stop. I was told the first hip replacement would last me a lifetime but I have been left a cripple by it.  I am appalled and furious about the damage it has done and the continued effect it has had on my life and my family.

“From being an active participant in life I am now confined to a very sedentary existence; no cinema, theatre, dancing, meetings, restaurants. In fact, any activity that requires sitting for a while in the same position or significant movement is now impossible.

“What has happened to me has been devastating. A medical product should not be allowed to cause such damage to patients. I cannot believe that a multinational corporation like Zimmer, with the resources it has, has been unable to identify these issues before the Durom hip was approved for use on patients. It seems like a basic error and it is just not acceptable.

“If any good can come from what I’ve faced, it is that steps are taken to improve the safety of these devices and ensure other people do not face the problems that I and many others have had to endure.” 

Our expert personal injury lawyers will provide you with free initial advice on your compensation claim if you have suffered as a result of metal-on-hip implants. See our Metal-On-Metal Hip Implants Claims page for more information.