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Unfit for purpose

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Unfit for purpose;
the MHRA's role in the PIP
breast implant scandal.

Doug Cross
12th January 2012

If any further evidence of the MHRA's incompetance in regulating medicines and medical products were needed, the latest fiasco should convince even its most ardent supporters. A Regulator that is incapable of detecting breast implants filled with industrial-grade silicone gel, normally used as a matress filling, for ten years is clearly unfit for purpose.

The MHRA’s latest catastrophic failure, this time over the defective PIP breast implants, demands an immediate radical overhaul of this totally discredited QANGO. Just as it has refused to follow the law on the regulation of fluoridated water as a medicinal product, so in the PIP case it has failed to exercise control over the quality of a registered medical device, silicone-filled breast implants.

Both the French regulator, AFSSAPS, and the MHRA were well aware that the manufacturer, PIP, had a history of dodgy practice with a previous implant. Yet it was able to get the mandatory CE , mark for its latest implants, the equivalent of a medical product licence for medicines, back in 2000, then for ten years fill the implants with a home-brewed mix of silicones that was not certified for medical use, but cheap.

Incredibly, both governments, and therefore the regulators as well, successfully had beast implants reclassified in a new EU Directive in 2003, that required all existing CE marks to be cancelled and the products to be subject to far more stringent scrutiny under the new Directive. Yet somehow, this fraudulent and potentially dangerous product slipped through the net, and was only exposed by an anonymous tip=off to the French regulator in 2010.

Now the MHRA is busily trying to blame everyone but itself for this appalling collapse in the regulation of a dodgy medical device used in around 40,000 women in the UK alone. The Dept of Health claims that there is no more risk of breast cancer in women with these implants than with other brands, and dismisses evidence that another form of cancer is found only around

silicone breast implants. So far about 60 such cases have been recorded.

The MHRA’s calamitous failure in this case is now part of a world-wide furore over these implants, yet the actual injury rate from them is far lower, and much less visible, than that caused by the MHRA’s refusal to regulate fluoridated water under the Medicines Directive.

The latest information to come out of Parliament reveals that the Agency’s refusal to recognise fluoridated water as a medicine, or to accept that it is in violation of the European Convention on Human Rights, is based on false assumptions and deliberate contempt of both the English and European Courts, and we are currently dealing with these through Parliament at the moment.

But this latest evidence that the MHRA is absolutely unfit for purpose must now precipitate an immediate review into this rogue quango, its incompetent management, and its clearly political association with vested interests in government. Like the French regulator, it has absolute and ultimate responsibility for protecting the public by implementing the demands of law. That it is manifestly and dangerously incompetent is now perfectly obvious.

Recently in Parliament the Secretary of State for Health, Andrew Lansley, said in Parliament that “The MHRA is answerable to me!” Now is the time for the Agency to do exactly that, only this time without the evasions and disinformation that have characterised its actions in the past.

For a review of how the company got away with this
breathtaking fraud for TEN YEARS -
and the MHRA failed to spot it,

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