Many thousands of patients in the UK who have been fitted with “mix and match” metal hip implant devices which have been put together using parts from different manufacturers are running the risk of serious disability and their implants failing.
The metal on metal hip replacements are most often used in patients who are younger and more active, and whose original hip joints have been damaged through injury or conditions such as arthritis. Some types of these hip joints have become less popular in recent years after evidence emerged that they were more likely to fail and need to be replaced before the typically expected 15 or 20 year lifespan.
“Off label” mix and match hip implants – the risks
However, it has recently come to light that some doctors are taking separate components from different manufacturers and putting them together in a single hip joint. These joints are known as “off label”, and using parts from various manufacturers can mean they do not fit together well into one joint, which can cause damage to bone, extra wear and tear on the joint, or in severe cases, pieces of metal breaking off and entering the bloodstream. This sort of “mix and match” joint is not approved by regulators for use in patients, and has not undergone the stringent testing which other hip implant devices have to undergo.
So far, doctors have identified ten patients who have had to have their “mix and match” hip implants removed before the five year mark because the joints have failed. It is also thought that most hip replacement patients do not know what sort of replacement joint they have.
The British Orthopaedic Association, the representative body for joint surgeons, spoke out to remind their members about the rising levels of concerns about some of the “mix and match” combinations being used.
Failed hip replacements- the health implications
There can be significant health impacts for those patients who are fitted with a hip replacement joint which fails. The main consequence is that they might need to undergo corrective surgery to replace the hip early, suffer trouble walking, face losing their job or need to be assisted with day to day tasks like washing or housework.
In 2013 alone, there were around 90,000 hip replacement operations carried out in the UK. Around 800 of those used large size, metal on metal joints. However, nobody knows how many of these included the use of mix and match replacement hip joints.
The main legal argument which is used when bringing a clinical negligence claim for a mix and match replacement hip joint which fails is that by taking components from different makers, the surgeon is actually creating a totally new medical device which should have to go through the normal system of testing. There are already a number of negligence claims underway involving people who have suffered from serious complications after having one of these hip replacements, and later discovered that their joint was made with the mix and match approach.
Mixing and matching components is not illegal, but guidelines state that it should only be done where there is no other option.
Mix and match hip replacements – the call for an independent review
Campaigning patient charity Action against Medical Accidents (AvMA) has called for a full review of “off label” medical devices to establish how widespread the problem is, and to take action against practices which may be dangerous. The AvMA has also demanded that surgeons using these sorts of devices explain all risks and explore alternatives with the patient before surgery.
According to the National Joint Registry, there were 620,000 hip replacements carried out in the decade between 2003 and 2013. 32,000 of these were the metal on metal type of replacement. It is thought that there are potentially thousands of patients who are unaware that they have been fitted with a mix and match joint.
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