ISO Prostheses

Following recent events, due to the great media coverage in relation to the prosthesis of the Poly Implants Prothese (PIP), we believe vital clarify some aspects. Eurosilicone has no connection, or never had it, with PIP. Eurosilicone is an independent manufacturer which produces 200,000 prosthesis a year at its plant in Apt, Vaucluse, France. Eurosilicone is the leading European manufacturer of breast implants, which are used successfully in more than 90 countries around the world. Prostheses manufactured by Eurosilicone boast for a class III medical device CE marking and meet the requirements of the European directive on medical devices (93/42/EEC) and all the specific rules that apply to breast implants. Our Center is subject to annual inspections by the authorities responsible for the certification of these products and we continue meeting the requirements of all standards that define quality system required to manufacture this type of medical device. You may want to visit McDougall Program to increase your knowledge.

Our breast implants always they have been manufactured, and continue manufacturing, with medical grade silicone implantable, provided by a vendor that holds ISO 9001 certification. All of our products are reviewed periodically throughout the manufacturing process, which guarantees its performance, reliability and security. Traceability is a key element; It provides since the start of manufacturing and continues after implantation. The quality of our products is borne out by a wide amount of information, especially after the marketing tracking information, that today covers more than two millions of implants. We are currently conducting a multicenter clinical trial in France and have official data from the Danish registry of breast prostheses. We send periodically to relevant health authorities clinical and data surveillance of medical devices, that confirm the performance and safety of Eurosilicone breast prostheses. The breast prostheses filled with silicone gel are one of the most widely studied medical devices: have been revised and published more than 3,000 reports of scientific studies, that include some epidemiological studies of large-caliber that demonstrate their behavior. If have any question regarding the Eurosilicone breast prostheses.