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Are UK regulators for approving medical devices following the correct due diligence?

Here is another article where devices are being released without the due diligence that we, as patients, would expect from the regulators and from the NHS.

‘MAGEC rods’ for use on children with curved spines was introduced.  The usual form of treatment would be inserting metal rods around the spine to straighten it.  But the rods need to be lengthened as the child grows which means operations every six months.  The idea behind the Magec rods is that they can be lengthened with magnets whilst still in the child’s body therefore reducing the need for repeat operations for the child and reducing costs for the NHS.

However there are numerous reported cases of the rods breaking whilst still in the child’s back. One only needs to imagine the excruciating pain that child must be suffering and the thought of having an operation to remove the broken parts and perhaps even replace the rods. To add to matters, titanium metal debris has been leaking into childrens spines.  Whilst no one yet scientifically knows the long term effect of the leak of titanium, you only need to consider cases such as the hip implants that have had similar leakages which have led to a number of long term effects on its patients and patients need to be regularly monitored.

This is a product that has been recommended by NICE, the body that decides the best practice for the NHS.  It is alarming how it has been approved by the regulators.  More statistics are required to determine how and why this product has been approved and, more importantly, if it is indeed best practice for the NHS to use it as the product of choice.  At the very least, the NHS should be providing more details to its patients about such products and advising about the risk so that parents can make better and informed decisions on behalf of their children.

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