Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-335-875"
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"en.20120614.22.4-335-875"2
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"−
I voted in favour of this motion for a resolution on defective breast implants made by the French company PIP. Although the company ceased trading in 2010, there are thousands of patients with defective breast implants filled with industrial silicone in Europe and beyond. I would single out the following problem areas: the absence of an implant register, control mechanism malfunctions, insufficient information and market monitoring. I welcome the idea of introducing an implant recipient’s passport and a common independent register of implants in the EU Member States. Not only would this help to trace the recipient of an implant made by a certain manufacturer but it would speed up the exchange of information between Member States, particularly when faced with defective implants. This case of fraud, which has affected the health of many patients, has revealed problems with the functioning of legislation at national and EU level. There needs to be an emphasis on stronger application of sanctions and control at European level instead of just leaving the Member States to address the issue. A patient not only needs to be given guarantees of the implant’s safety, but sufficient information on quality, risk factors and information about possible implant replacement. For this reason there needs to be effective and good-willed cooperation between all links in the chain: manufacturers, medical bodies and patients. Due to market control and the monitoring of manufacturers I spoke in favour of coordinated action by inspectors in the Member States, the random checking of selected implants and the auditing of manufacturers. Checks must be carried out before implants enter the market or companies are given licences to trade – thus establishing a preventative system, which prevents a repeat of the case of the French company where the industrial silicone used in breast implants leaked into patents’ tissue."@en1
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