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外文期刊>Geburtshilfe und Frauenheilkunde
>The 'PIP scandal' - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report Der ,,PIP-Skandal' - Komplikationen minderwertiger Brustimplantate: aktueller Wissensstand, behordliche Empfehlungen und Fallbericht
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The 'PIP scandal' - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report Der ,,PIP-Skandal' - Komplikationen minderwertiger Brustimplantate: aktueller Wissensstand, behordliche Empfehlungen und Fallbericht
Following the clinical observation of high rate of ruptures of breast implants of the French manufacturer Poly Implant Prothese (PIP), the French Health Products Safety Agency (Afssaps) removed these products from the market in March 2010. Physical and toxicological tests confirmed the use of silicone of improper quality both for the shell and the gel filling. Until now (12/2011), no acute toxicity or mutagenicity could be observed, but 20 cases of malignancies occured in carriers of PIP-prostheses. By means of a clinical example, we summarize the official recommendations of the Afssaps and its German equivalent, the Bun-desinstitut fiir Arzneimittel und Medizinprodukte (BfArM) for diagnosis and treatment in women with PIP breast implants. Furthermore, we intend to raise awareness for the fact that the German GfE Medizintechnik and the Dutch manufacturer Rofil distributed the identical product with a different label. Supplementary, the medical and medico-legal aspects of the "PIP scandal" are discussed.
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机译：在法国制造商Poly Implant Prothese（PIP）制造商对乳房植入物发生高破裂率的临床观察之后，法国健康产品安全局（Afssaps）于2010年3月将这些产品从市场上撤下。物理和毒理学测试确认使用了外壳和凝胶填充质量不佳的有机硅。到目前为止（12/2011），尚未观察到急性毒性或致突变性，但在PIP假体载体中发生了20例恶性肿瘤。通过临床实例，我们总结了Afssaps及其德国等效产品Bun-desinstitut fiir Arzneimittel und Medizinprodukte（BfArM）的官方建议，用于诊断和治疗PIP乳房植入物的妇女。此外，我们打算提高对以下事实的认识：德国GfE Medizintechnik和荷兰制造商Rofil分发了具有不同标签的相同产品。补充地，讨论了“ PIP丑闻”的医学和医学法律方面。
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