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Is UK regulatory process for approving medical implants reliable?

There is an investigation by Swiss prosecutors into a total disc replacement implant created in the UK and approved by UK authorities although it was later removed in 2014. 90% of the devices were exported to Europe.  It has left patients in agony and needing further surgery after it broke inside their backs.

The implant was created by Cambridge based Ranier Technology. It was approved in the UK despite there being failings when it was tested on six baboons which showed “worrying changes in the implant and the bone in all but one subject”. To add to matters, one of the surgeons who were on Ranier’s scientific advisory board (Mr Abei) implanted the device into at least seven patients.

Questions need to be asked on two fronts. 

Firstly, what is the detailed process of approving such products? As part of the regulations do inventors need to disclose all investigations including those that are negative? If this is not a part of the regulations, then serious consideration must be given to this and amendments need to be made, however, if such disclosure is required are the consequences of breach that follow serious enough to discourage rogue behaviour? May be further thought needs to be given to this matter by the regulators.

Secondly, do individuals such as Mr Abei owe a greater duty of care to their clients when dealing with a product in respect of which they have far more detailed knowledge and insight? Most would agree they do.  No doubt you would expect Mr Abei to provide detailed written and oral advice to his clients stating the implant is new, the tests were not entirely conclusive and there are risks including detailing what those risks may be. I hope that Mr Abei took these steps and obtained full and proper consent from his clients before proceeding with the implants.

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