Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-338-375"
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"en.20120614.22.4-338-375"2
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"I voted for the report on defective silicone gel breast implants made by the French company PIP (Poly Implant Prothèse). The tests conducted by the French authorities on the physical integrity of a PIP silicone breast implant sample indicated weaknesses in PIP breast implant shell, not found in other implants available on the market. Due to the lack of EU-wide registration of breast implants, the total number of women who have received implants is unknown. However, on the basis of the data provided by the European Commission, it is estimated that around 400 000 PIP silicone breast implants have been sold worldwide. Most PIP silicone breast implants were sold in the United Kingdom (40 000), France (30 000), Spain (10 000), Germany (7 500) and Portugal (2 000). The case of PIP implants demonstrated the failure of the current certification system to comply with essential health and safety requirements, deficiencies in the inspections carried out by notified bodies, as well as the lack of surveillance of PIP implants by national competent authorities pursuant to the Medical Devices Directive (2007/47/EC). I recommend that the Medical Devices Directive be revised with a view to introducing the ability to detect and minimise the risk of fraud, focusing in particular on provisions regarding market surveillance, so as to avoid a repetition of the PIP case."@en1
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