Informasjon fra Allergan om PIP proteser
All Allergan implants are manufactured at our state-of-the-art facility using silicone and saline that is approved for use in medical devices and are designed to meet all relevant national and international Quality Control Standards and Current Good Manufacturing Practice (CGMP). Allergan is audited many times a year by various regulatory authorities including the European Notified Bodies and the U.S. Food and Drug Administration (FDA), to ensure its ongoing compliance with all applicable regulations and legislation such as the European Medical Devices Directive, US FDA regulations and guidance and relevant International Organization for Standardization (ISO) Standards, as well as the Company’s own exacting requirements. Such procedures ensure that all of Allergan’s medical devices are manufactured under a strictly controlled environment and that there is an established and validated process to ensure the consistency and quality of each device. From start to finish, it can take up to 12 days to manufacture an Allergan breast implant which undergoes almost 100 quality control tests, including materials inspection, product inspection and testing. These standards mean that every implant and tissue expander we manufacture is thoroughly evaluated for quality and durability.