Which directives? CE marking is not an EU directive. EU directives are something like federal laws, binding upon nations that comprise the EU, but each nation does its own thing within the limits of the Directive. Thus far there are none relating to breast implants, and if one is written it will be a first - and not without its challenges: the UK government might find itself resisting sane regulation because there are elements within the Conservative party (which dominates the Coalition) that want less, not more European harmony. Not right, not wrong, but a political reality that will probably cause any EU directive serious problems.
http://www.independent.co.uk/news/u...es-will-create-dilemma-for-no-10-6286782.html
CE marking seems to be a scheme whereby, as someone remarked earlier in this thread, as long as everyone tries to do the right thing, it works. TuV are arguing that, since PIP lied, they (TuV) are off the hook. It seems that CE auditors do not feel obliged to sniff out fraudulent reporting. Let's be clear: PIP behaved fraudulently and TuV didn't spot it.
By the way, is nobody but me shocked that clinics regard a 1.3% rupture rate as okay? I think that's fraudulent reliance on the faith we place in the medical profession, which surely goes for better general success rates in surgery, drug treatments and medical devices.
http://www.bbc.co.uk/news/health-16466918
UK breast implant providers are claiming that it's not their fault that their supplier evaluations were inadequate, but the Government's:
http://www.guardian.co.uk/world/2012/jan/09/breast-implants-refusal-free-replacement
They're scared they'll go out of business; no thought for their patients, who might face rather worse prospects.
The system of CE marking, government oversight and for-profit clinics with pathetic expectations of success (100 - 1.3 = 98.7%) failed to protect vulnerable women from fraud. If it can't do that, what's it for?
I think that this is a criminally immature industry learning that if you screw up in your supplier evaluations and mess up the lives of your patients, they will blame you. The only result for clinics from this sad state of affairs is a marked reduction in business caused by a loss of faith in clinics and their commitment to their patients. Clinics need to expect more of independent audit schemes and do their own evaluations as well, and not be seduced into undue indilligence by low prices. They also need to insure themselves properly against failure, rather than plead that they'll go out of business should they do the morally right thing and fix things at their expense for their anxious patients.
There's a lot wrong.