MEPs at Public Health Committee ask for a new legislation to protect patient safety

The debate held at the Environment and Public Health Committee by MEPs and European Commission representatives ended with the petition to the Commission by MEPs to introduce stricter controls and better traceability of the medical devices such as silicone breast implants.

MEPs at the Environment and Public Health Committee in the European Parliament asked to the Commission to propose a new legislation in order to protect patient safety. MEPs are concerned for the recent news on defective breast implants. Up to 500,000 women, mostly outside the EU, are believed to be affected. Linda McAvan author of a parliamentary "oral question" on the issue showed herself pleased that the European Commission is dealing with this seriously and quickly.

Representatives of the Commission said that the Commission was conducting a "stress test" on a proposed update to EU legislation on medical devices, currently due to be published in March, to see whether it would address shortcomings exposed by the reported use of low-grade silicone in breast implants by French manufacturer PIP. Towards a cross-border healthcare is still one of the EU objectives.

Chris Davies, MEP, was concerned about the possibility for national authorities to intervene once a CE safety mark has been approved. The Commission replied that France was within its rights to block the use of the implants, acting on a possible link to cancer. On the other hand, Peter Liese, MEP, backed the idea of introducing unannounced spot checks and better traceability throughout the supply chain.