Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-13-Speech-3-615-000"
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"en.20120613.33.3-615-000"2
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"Madam President, Commissioner, we had the Mediator scandal some time ago. We now have the breast implant scandal, which, as you said, Commissioner, unfortunately highlights the shortcomings of health security in Europe.
The breast implant scandal is a case of fraud that went unpunished for 14 years, from 1996 to 2010. During that time, 500 000 implants were placed on the market, 8 000 implants were removed, 48 cases of cancer were reported, and 3 500 complaints were lodged. These are frightening, shocking figures. Commissioner, how, despite warnings from the U.S. Food and Drug Administration (FDA) and the numerous complaints and convictions for ruptured implants in Great Britain and France in particular, could national and European agencies miss such a fraud?
This tragedy immediately made us think about improving the European regulatory system for medical devices, as you explained just now. Commissioner, today we must build a system capable of preventing scandal, but it must be a new system. You told us about the new legislation to come into effect this autumn. As co-author of this resolution, I am, of course, pleased with that.
However, Commissioner, you seem to want to take into account many of our concerns, as set out in this resolution. In that case, why make an exception that is unacceptable to a large number of MEPs here in this House? Why not introduce a market authorisation for medical devices in class III, those that are highest risk? Commissioner Dalli, can you explain your position to me?"@en1
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