Eurosilicone Press Release

Following the recent events and media coverage concerning Poly Implants Prothèse (PIP) implants, we feel it is very important to provide some clarification.

Eurosilicone has no relationship and never had any kind of relationship with PIP. Eurosilicone is an independent manufacturer, producing 200,000 implants per year at its facility in Apt, Vaucluse, France. Eurosilicone is the leading European manufacturer of breast implants and have been used successfully in more than 90 countries across the globe.

Implants produced by Eurosilicone, are CE marked, Class III medical devices and meet the requirements of European Medical device directive (93/42/EEC) and all standards specific to breast implants. Our site is inspected annually by authorities responsible for the certification of these products and we continue to meet the requirements of all standards that define the quality system necessary to manufacture of this type of medical device.

Our breast implants have always been and continue to be manufactured with long-term implantable medical grade silicone supplied by an ISO 9001 certified source. All our products are regularly checked throughout the manufacturing process which ensures their performance, reliability and safety. Traceability is key and is provided from the start of manufacture and continues post-implantation.

A large quantity of information corroborates the quality of our products, notably post-market follow-up which today covers more than 2 million implants. We are currently carrying out an ongoing multi-centre clinical trial in France and we have data from the Danish register of breast implants. Medical device vigilance and clinical data are regularly sent to the appropriate health authorities and confirms the performance and safety of Eurosilicone breast implants.

Breast implants prefilled with silicone gel are some of the most widely studied medical devices, with more than 3000 study reports reviewed and published, including serious epidemiological studies which prove their performance.

Should you have any questions in relation to Eurosilicone implants please email contact@eurosilicone.com.

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