Acta Chir Plast. 2015;57(1-2):17-23.
Non-compliance with the production process and use of non-certified materials du- ring production of PIP implants opened an extensive debate regarding regulation and control mechanisms during their production, but the question of health safety of breast implants in general was also reopened. Production of breast implants is subject to various control mechanisms in each country and it is necessary to unify and coordinate such mechanisms. PIP implants were on the market for more than 15 years and in this period the production process and used materials were being changed purposely and without control, which resulted in production of implants with poor quality capsule filled with non-certified silicon gel. There were around 600,000 of these erroneous implants produced. Despite demonstrable harmfulness of the PIP implants, the current studies were not able to reliably confirm health hazard of these implants. Financial costs together with the inability to demonstrate health risk of PIP implants is the reason why the question to widely replace these implants was not solved and each state has a different opinion on this issue.
在生产聚对苯二甲酸乙二醇酯（PIP）植入物过程中不遵守生产流程以及使用未经认证的材料，引发了一场关于其生产过程中监管和控制机制的广泛辩论，同时，乳房植入物总体的健康安全问题也再次被提了出来。每个国家的乳房植入物生产都受到各种控制机制的约束，因此有必要统一和协调这些机制。PIP植入物在市场上销售了15年多，在此期间，生产过程和使用的材料被故意且无管控地更改，这导致生产出质量不佳、填充了未经认证硅胶的植入物胶囊。这类错误生产的植入物约有60万例。尽管PIP植入物的危害已得到证实，但目前的研究仍无法可靠地确认这些植入物对健康构成的危害。经济成本以及无法证明PIP植入物的健康风险，是这些植入物未被广泛替换这一问题未得到解决的原因，而且每个国家在这个问题上都有不同的看法。
