020 7650 1200

Lawyers welcome NHS hip ban

Reports in Daily Telegraph welcomed by lawyers representing hundreds of alleged fault hip victims

Posted on 26 October 2013

Leading lawyers acting for people fitted with allegedly faulty hips have welcomed reports in the Daily Telegraph that NHS hospitals are to be banned from fitting metal-on-metal hip replacements.

Leigh Day represent over 750 alleged victims of metal on metal hips and have been calling for more stringent regulation of medical devices for a number of years.

The ban follows research involving 17,000 patients, which found failure rates as high as 43 per cent among some of the implants.

On 18 October NICE published their long awaited appraisal consultation on using total hip replacement and resurfacing arthroplasty in the NHS in England and Wales.

The NICE Appraisal Committee have made the preliminary recommendation that prostheses should only be recommended as a treatment option if the prosthesis has a revision rate (or projected revision rate) of less than 5% at 10 years.

This halves the existing NICE “benchmark” and recognises the fact that metal-on-polyethylene prostheses, such as the cemented Charnley device, which has been used in the UK for nearly 20 years, offers far better durability than any of the metal-on-metal stemmed prostheses that have been introduced into the UK market by companies such as Depuy.

If upheld, the new “benchmark” recommended by NICE, will mean that all new and existing prostheses on the UK market should have a revision rate of less than 0.5% per year.

In effect, this will mean that, on the basis of data currently available through the UK National Joint Registry, all metal-on-metal total hip replacement products would be prohibited from entering the NHS Supply Chain.

NICE are expected to publish their final position by February 2014. Leigh Day have already submitted their response to NICE supporting this proposed revision.

One of the devices, the DePuy ASR was withdrawn after manufacturers admitted to failure rates of 13 per cent within five years. This required revision surgery in almost a quarter of cases within that period. After nine years, failure rates are estimated to be 43 per cent, according to an audit of all hip surgery in England, Wales and Northern Ireland.

The metal-on-metal resurfacing models found to have such high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus.

The Corail/ Pinnacle total hip replacement using ceramic on metal, and the Pinnacle Ultamet metal-on-metal device, also manufactured by Depuy, have also demonstrated high failure rates according to data published by the National Joint Registry which was set up to monitor the survivorship of all prostheses.

Martyn Porter, past president of the British Orthopaedic Association, said:

“It first started to become apparent among surgeons about three years ago.

“We were starting to see high revision rates but this is like watching a car crash in slow motion — at first, you just don’t know how bad it is going to be.”

He said the scale of the problem was “extremely disappointing”.

He said: “These devices, which were supposed to be innovative, had such poor results.”

Mr Porter said any patients who suspected problems with a metal-on-metal device should see their doctor.

“The important thing is identifying and investigating the cases where there are problems because if you leave it too long it can cause tissue destruction.”

Boz Michalowska, Partner in the Medical Devices team at Leigh Day said: “We certainly welcome these reports suggesting these devices are finally being phased out of use in the NHS. We have seen too many failed implants, necessitating further surgery, to think that there could be a future for these kinds of devices.

"The proposed lowering of the NICE 'benchmark' level against which the durability of all prostheses will be assessed, if enforced, will put patient safety back at the heart of NHS device procurement, and also recognises the fact that some of the oldest devices available, such as the Charnley metal-on-polyethylene prosthesis have proven to be more durable than many of the new products that have been rushed into the market in recent years."