Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-333-000"
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"en.20120614.22.4-333-000"2
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".
According to the findings of the French health authorities, a French manufacturer (Poly Implant Prothèse) is under investigation for the fraudulent use of low-quality material (industrial silicone) different from the material indicated by the manufacturer in the conformity assessment documents (approved medical-grade silicone). As EU-wide registration of breast implants does not exist, the overall number of women who have received implants is unknown, although it is estimated on the basis of the available data provided by the European Commission that around 400 000 PIP silicone breast implants have been sold worldwide. I firmly believe that patients need to know that implants are not permanent and may need to be replaced or removed. Patients also need to be informed about the quality of implants and the potential risks associated with them. Despite this, however, the transposition of EU legislation on medical devices into national legislation has not prevented this health fraud, which has had, and will continue to have, a serious negative impact on health worldwide. In this context, I consider it justified for the Member States to raise awareness more effectively of the potential risks attached to cosmetic surgery, and to better regulate the advertising of cosmetic surgery in order to ensure that patients are fully aware of the risks as well as the benefits. I also think it is appropriate to develop a suitable legal framework to guarantee the safety of medical technology in general."@en1
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