Breast implants fall under the European legislation for high risk medical devices, which requires that, before they are being put on the market, manufacturers must carry out an assessment to ensure that they fulfil legal requirements and will not compromise patient safety. A third party conformity assessment body must be involved in the conformity assessment procedure.

An investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010, however it is estimated that hundreds of thousands of PIP silicone breast implants were sold. The opinion published by the SCENIHR, an advisory body established by the Commission, sums up the current scientific knowledge on this case.

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants as they differed strongly between individuals.

Next steps

Following the opinion, the European Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States.

In addition, the Commission is discussing with the Member States how surveillance of medical devices already on the market can be reinforced immediately within the existing legislative framework. In parallel a "stress test" of the legislation on medical devices is under way in order to identify how the questions raised by this issue can best be addressed in the revision of the Medical Devices Directive, scheduled for spring 2012. The revision will take into account the lessons learnt from this case, which will reinforce the importance of market surveillance, vigilance and functioning of notified bodies.

EPHA will be following relevant developments to ensure that patient safety is respected across Europe. New data shows that the number of patients killed or seriously injured by medical devices has risen sharply in recent years not only due to unsafe devices, but also their incorrect application by hospitals, private clinics, and their users. This includes injuries caused by implants as well as by other devices such as surgical equipment, life support machines, etc.

For further information
- European Commission Press Release
- DG SANCO website - Medical devices

EPHA related articles

- article 4681
- article 4109
- European Commission proposes mandatory use of medical devices database
- A Europe without needlestick injuries
- article 3360
- EPHA Briefing on Cross-border Patients’ Rights Directive

Last modified on February 20 2012.