Poisonous hip implants 'putting thousands of British patients at risk' as medical watchdog launches investigationMedical regulators forced to take 'prompt action' over safety concernsMetal hip implants could put more than 30,000 patients at risk of poisoning


Agony: Penny Brown, 51, is taking legal action against DePuy after her implant wore out leaving her disabled

Agony: Penny Brown, 51, is taking legal action against DePuy after her implant wore out leaving her disabled

Hip replacements fitted in tens of thousands of patients are being investigated amid fears they may be poisoning them.

Medical regulators are considering new evidence about ‘metal on metal’ implants disintegrating, destroying muscle tissue and leaking metal into the bloodstream.

It comes as surgeons say that implants which have now been recalled have a failure rate of nearly 50 per cent after six years.

Some patients, however, may be unaware of the dangers.

Hip replacements, and less drastic hip resurfacing, usually offer a patient a 95 per cent chance of pain-free mobility for ten to 15 years.

But problems can occur with all-metal implants – used on 40,000 patients – when friction between the components causes tiny metal fragments to break off.

In 2010, two hip implants made by company DePuy were withdrawn from the market after concerns about their safety.

These accounted for around 10,000 of the metal on metal hips fitted in the UK since 2003.

Lawyers representing hundreds of patients who were given the DePuy ASR – used in hip resurfacing – and ASR XL – used in a full replacement – are preparing compensation claims which could run into six figures.

All patients with these products are advised to see a doctor to check levels of cobalt and chromium in their blood and whether they have any muscle damage.

It is unclear if all patients are aware of the risks. The British Orthopaedic Association suggested in a letter to surgeons that only 41 per cent had applied to be reimbursed for their treatment by DePuy.

Doctors say metal fragments could be toxic to the kidneys, and can also inflame tissue around the bone, destroying muscle.

Risk: Metal hip replacements by DePuy have already been recalled by hospitals for tests

Risk: Metal hip replacements by DePuy have already been recalled by hospitals for tests

Metal hips: Concerns are growing that small particles of metal in these devices could poison patients

Metal hips: Concerns are growing that small particles of metal in these devices could poison patients

HIP IMPLANTS Q & A

What is a metal on metal implant

Traditional hip replacements – carried out since the 1950s – used a metal ball and a plastic socket. In the 1990s, however, metal on metal types became popular.

In these products both the femoral ball, which sits on top of the leg, and the acetabular socket it fits into which is attached to the hip, are made of metal.
It was thought these could cope with more wear and tear.

Around 40,000 have them and they are still being fitted.

What is the concern

In 2010, regulators became worried about the number of patients needing their operations redone because their muscle tissue had been damaged by the metal on metal hips.

It turned out tiny metal particles were getting into the blood, poisoning it and leaving patients in pain and with lasting damage to tissue. If the problem is not identified early enough, further operations can be more difficult.

Are all MoM hips dangerous

The Medicines and Healthcare products Regulatory Agency ordered two types of hip implant manufactured by DePuy to be taken off the market.

Surgeons say their failure rate could be 50 per cent after just six years for full hip replacements, far higher than previously thought. Other metal on metal implants – of which the most popular is the DePuy Pinnacle – may also have higher than average failure rates, but there is not enough evidence yet to be sure.

What should I do if I have one

If you have a DePuy ASR or ASR XL implant or do not know whether you do, you are advised to see your doctor and ask for a blood test to check the metal level, even if you are not experiencing any pain.

If you have another brand of metal on metal implant you are advised not to panic, but to have an annual check-up for five years. There is a website for ASR patients at asrrecall.depuy.com. DePuy has a helpline on 0800 2794865.

What is happening now

The MHRA is drawing up a new alert for everyone with a metal on metal implant because surgeons fear the devices are more dangerous than had been appreciated. It is likely to be stronger than the existing warning. It also appears some patients with recalled implants may not be aware of the risks.

Surgeons in the North East have compiled
figures for 500 patients with DePuy implants showing a failure rate of
up to 35 per cent after four years and 49 per cent after six years for
full hip replacements.

Tony Nargol, an orthopaedic surgeon at North
Tees and Hartlepool NHS Trust, said: ‘If some patients haven’t been
told, that is appalling. We have been saying to the world that these
implants are wearing out and there could be problems ahead, but we need
to ensure the public gets the message.’

He said doctors should give
all patients with an ASR – which stands for articular surface
replacement – a blood test, take a sample from the liquid around their
joint and have an ultrasound to check for damage.

Surgeons from
Belfast and Cardiff also noted high failure rates for DePuy. The failure
rate from other metal on metal devices can be as high as 15 per cent
and patients are advised to have annual check-ups for five years.

IT
consultant Penny Brown, 51, had a DePuy ASR resurfacing implant after
years of gymnastics and skiing left her with a painful right hip. She
was so pleased with the results, she agreed to help promote DePuy’s
services.

Eight years later, however, she is taking legal action after
her implant wore out and left the surrounding tissue full of debris.

It
has since been removed. She said: ‘I cannot sit or stand for long
periods and I’m a shadow of my former self. I’m no longer the hard
working, vivacious woman I used to be and would still be if I had not
had this implant.’

Metal on metal replacements became popular in the
1990s as they were thought to be more resilient than metal and plastic.

Bozena
Michalowska of law firm Leigh Day, which is representing more than 300
victims, said patients may be entitled to compensation.

The
Medicines and Healthcare products Regulatory Agency yesterday said it
was consulting clinical experts on drawing up new guidance.

A spokesman
said it had taken ‘prompt action’ over safety fears but added that most
people with metal on metal replacements were at ‘low risk of developing
serious problems’.

A spokesman for DePuy, a subsidiary of Johnson
& Johnson, said the firm was working to support patients and
reimbuse victims and doctors.

He said figures from the National Joint Register showed a failure rate of 17 per cent for ASR replacements after five years.