Opinion on The safety of Poly Implant Prothèse ( PIP ) Silicone Breast Implants

.............................................................................................................5 1. EXECUTIVE SUMMARY......................................................................................... 10 1.1. Incidence of implant failures ........................................................................... 10 1.2. Chemical composition of PIP implants............................................................... 10 1.3. Exposure considerations ................................................................................. 11 1.4. Toxicological properties................................................................................... 11 1.5. Consequences of implant failure ...................................................................... 11 1.6. Generic Risks and Benefits of removal of PIP silicone breast implants..................... 12 1.7. Recommendations for further work .................................................................... 12 2. BACKGROUND ................................................................................................... 14 3. TERMS OF REFERENCE........................................................................................ 15 4. APPROACH USED TO DEVELOP THIS OPINION ........................................................ 16 4.1. Summary of the previous opinion..................................................................... 16 4.1.1. Recipients of implants .............................................................................. 16 4.1.2. Reasons for breast implant failure .............................................................. 16 4.1.3. Measurement of implant failures ................................................................ 16 4.1.4. Possible adverse health consequences ........................................................ 16 4.2. Design and administration of the SCENIHR questionnaire .................................... 17 4.3. Data sources used to develop the current opinion............................................... 18 4.3.1. Literature published since the last Opinion in February 2012 .......................... 18 4.3.2. Reports produced by individual Member States and other governments ........... 20 4.3.3. Incident reports collected by the IPRAS (International Confederation for Plastic Reconstructive and Aesthetic Surgery) network) .............................................. 20 4.3.4. Variability in the quality of PIP implants ...................................................... 20 5. PHYSICOCHEMICAL PROPERTIES OF PIP IMPLANTS............................................... 21 5.1. How a silicone gel breast implant is manufactured .............................................. 21 5.2. Properties of PIP implant shells........................................................................ 21 5.3. The contents: Chemical composition and physical properties of PIP implant gels ................................................................................................................. 22 5.4. Cyclic silicones in PIP implants......................................................................... 24 5.5. Conclusions from Physico-Chemical Studies on PIP implants ................................ 25