Rivera Juan Carlos
Chirurgie plastique, reconstructrice et esthétique, 19, rue de l'Observatoire, 67000 Strasbourg.
Ann Chir Plast Esthet. 2020 Feb;65(1):1-6. doi: 10.1016/j.anplas.2019.06.010. Epub 2019 Jul 19.
Since the dawn of breast implantation back in the sixties, five generations of breast implants have tried to provide the most natural-looking results while striving to eliminate the risk of unpleasant ruptures or capsular contractures. National Health regulators (i.e. the FDA in USA and ANSM in France) have had an "after the facts" reaction, which led to a so-called "dirty war" among producers in the form of a 1992 Silicone's Moratorium (after suspicions of associated cancer or immune-related disorders) all this under the rigid oversight of a FDA director, who seemed more sensible to media scandal than scientific data. After more than a decade of consistent scientific evidence, the interdiction was finally ended in France in 2001 and in the USA in 2006, however the scandals resurfaced again in 2011 after a proven fraud on the "PIP - affair" and most recently with "breast implant associated - anaplastic large cell lymphoma", an extremely serious and rare pathology, treated only by surgical means, until further research. We describe also a chronology on the way the FDA finally recognized this dramatic complication.
自60年代隆胸植入手术出现以来，五代隆胸植入物一直致力于在努力消除不愉快的破裂或包膜挛缩风险的同时，提供最自然的外观效果。各国卫生监管机构（如美国食品药品监督管理局和法国药品安全局）采取了“事后”反应，这导致了生产商之间的一场所谓“肮脏战争”，形式是1992年的硅胶禁令（在怀疑与癌症或免疫相关疾病有关之后），这一切都在一位食品药品监督管理局局长的严格监督之下，这位局长似乎对媒体丑闻比对科学数据更敏感。经过十多年一致的科学证据，法国于2001年、美国于2006年最终解除了禁令，然而，在“PIP事件”被证实存在欺诈行为后，丑闻在2011年再次浮出水面，最近又出现了“隆胸植入物相关间变性大细胞淋巴瘤”，这是一种极其严重且罕见的病理情况，在进一步研究之前只能通过手术手段治疗。我们还描述了食品药品监督管理局最终认识到这种严重并发症的过程年表。
