EU Silicone Breast Augmentation Scandal Response

- May 14, 2020-

EU silicone breast augmentation scandal response

According to the latest news report of Xinhua News Agency, the European Commission proposed new regulations for targeted medical device supervision on September 26, with the aim of preventing the inferior breast augmentation silicone products from France from flowing into the market. The occurrence of this event is not accidental, there is inevitability.

Relevant personnel responsible for health and consumer affairs in the European Union put forward that after the transfer of the inferior breast augmentation silicone products produced by the French polyimplant prosthesis company (PIP) to the market, it brought serious health risks to users. Considered a major medical scandal.


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(1) Definite rights and obligations of medical device manufacturers, importers, distributors, etc .; (2) Strengthen the identification of related devices, and stop the traceability of accidents in a timely manner; (3) Strengthen the power of medical device quality assessment agencies And responsibilities; (4) Strengthen EU inter-temporal supervision cooperation.


After the French breast augmentation silicone scandal was exposed, the European Union made specific reform measures in terms of regulation, which were generally consistent with the new rules. The scandal protagonist PIP was once the world's third-largest manufacturer of silicone implants, with an annual output of 100,000 pieces, of which 80% of silicone products are exported. The victims of inferior silicone are mainly concentrated in South America and Western Europe.