A study of 17,000 patients who were fitted with a metal on metal hip replacement showed unacceptable levels of failure, and this has led to the metal on metal device being banned from NHS hospitals, following 1000s of injury compensation claims worldwide.
Surgeons had previously voiced concerned about the hip joints, stating that the early failure rates are due to the joints wearing away. There are further concerns that the joints have the potential to leak toxic metals. A quick response from the NHS has led to two commonly used models of replacement hips have already been withdrawn from the UK market, and patients who have already had the suspect models fitted have been recalled to hospital for regular checks and blood tests.
Regulators in the health industry have issued new guidelines to doctors which state that any hip implant with a failure rate of more than 5% after 5 years should be withdrawn from use immediately. This new regulation means that nearly all metal on metal hip implants should no longer be fitted in patients. As well as the two implants already withdrawn, the use of five more metal on metal hip implants will be discontinued with immediate effect.
NICE (National Institute for Clinical Excellence) have issued the warning to NHS hospitals after their figures showed that some of the most poorly performing implants have a failure rate as high as 43%.
The NICE results come after a survey of all metal on metal hip surgery in England, Wales and Northern Ireland. This survey found failure levels below NICE’s acceptable levels in most of the metal on metal hip devices on the market. Other types of hip replacements use a plastic socket with a metal ball.
Almost 25% of patients who were fitted with on particularly poorly performing implant, the DePuy ASR needed corrective surgery within five years, and the overall failure rate was 13%. After nine years of initial surgery, the failure rates for the DePuy ASR implant were as high as 43%.
Similar metal on metal hip replacements were used in a slightly different procedure known as hip resurfacing, which is designed to improve quality of life for younger patients than those needed a total hip replacement. In these cases, failure rates were as high as 14% after five years, and by nine years, the failure rate had risen to 36%. Other metal on metal or ceramic on metal implants used for resurfacing in over 11,000 patients showed five year failure rates above the 5% threshold. Within nine years, failure rates for some of the implants rose to 16%.
The metal on metal hip implants affected by the high failure rates are:
• Cormet 2000
• Recap Magnum
• Conserve Plus
The Corail Pinnacle hip replacement implant which is made with ceramic on metal was another device which failed to meet NICE’s standards. Only two types of metal on metal hip replacement currently being used in NHS hospitals exceed the standards set down by NICE, and only just. This means that nearly all of this type of implants in use in the UK are now banned.
Given that metal on metal hips only begin to fail over time, surgeons are only just now becoming aware of the growing issue with this type of implants. Medical staff began to be aware of these problems three years ago. Even the best performing metal on metal hip replacement fails four times as often as other types.
If you suspect that you have one of these metal on metal hip replacements fitted, NICE recommends making an appointment to see your GP as soon as possible. There is a possibility of tissue damage if the failing implant is left in place for too long. Metal on metal devices were first used in the 1990s, but increased in popularity in the last 10 years. By 2008, 11,000 patients per year were being fitted with these devices.
Makers of the metal on metal hip replacements called the raw data into question, and claimed that the rates may be lower when adjusted for accuracy. Other makers, such as the manufacturers of the Cormet 2000 stood by their products, and other manufacturers refused to comment on the NICE recommendations.
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