Regulatory inspection fails. Warning fails also.


Inspection is being sold as “confidence”.  The latest breast implant scandal, involving those made by the French firm Poly Implants Protheses (PIP), reveals that neither regulation nor warnings from medical experts stopped the use of substandard materials in time.  To be fair though, they hadn’t paid for the protection of confidence through accreditation.

However, in the US, the FDA inspected and warned about problems with another of the company’s products in 2000.  UK surgeons warned about this product’s danger based on their experience of its defective nature.  If their opinions had been more widely publicised and heeded, the market could have sorted out this problem years ago.  But the MHRA and the European regulatory system failed for over a decade in this case.

Read about it here.

And here.

Maybe next time…less inspection…more brain…

Inspector in training

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This entry was posted in Cartel, Medicine, NHS, Practical problems and tagged , , , , , , , . Bookmark the permalink.

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