The Commission requests a further in-depth study on the potential health impact of faulty breast implants

Scientists concluded on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company that data available was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants. However the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market.

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was in charged by the Commission of carrying out a study on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company. The SCENIHR report stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon. MEPs at the Public Health Committee asked to introduce stricter controls and better traceability of the medical devices such as silicone breast implants.

Scientist also concluded that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues. With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, the report highlights that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

In the light of these results, the Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States. It will also discuss with the Member States how surveillance of the medical devices can be reinforced immediately within the existing legislative framework.