[Breast implants and quality process]

Quality processes have been compulsory for breast implants manufacturing since June 14th 1998. According the new article dated July 2005 the 11th (R 74-4), it also becomes compulsory for plastic surgeons to follow some strict quality processes in practising breast implants. A recent new quality approach was carried out over 302 patients who had breast implants. Herewith our primary conclusions: Some best practises have been defined as the benchmark. (What is supposed to be done or not to be done). A flow chart shows the interaction between the different processes required for a good quality system. Key indicators for monitoring quality levels are indicated: patients satisfaction survey, both reporting of problems and surgery recalls.