Defective breast implants: new legislation must protect patient safety 

Press Releases 

Medical devices such as silicone breast implants, should be subject to stricter controls and better traceability, said MEPs and European Commission representatives at an Environment and Public Health Committee meeting this morning.

The Commission said it 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. Up to 500,000 women, mostly outside the EU, are believed to be affected.

"I am pleased the European Commission is dealing with this seriously and quickly", said Linda McAvan (S&D, UK), author of a parliamentary "oral question" on the issue, adding that as many women are unsure whether their breast implants are defective, unique identification of products could ensure effective tracking in future.

Ms McAvan also highlighted the need for better cooperation within the EU and internationally, noting that problems identified by the US Food and Drug Administration (FDA) several years ago had come to light only very recently.

Peter Liese (EPP, DE), backed the idea of introducing unannounced spot checks and better traceability throughout the supply chain. Such measures need to be taken at European level, said Richard Seeber (EPP, AT).

Chris Davies (ALDE, UK), 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.

Michèle Rivasi (Greens/EFA, FR), regretted that more surgeons had not reported cases of burst implants and said that national agencies should respond more quickly when problems are discovered.

While the European Commission indicated that it was not planning to propose pre-market authorisation for medical devices, Dagmar Roth-Behrendt (S&D, DE) said that this might be appropriate to do so for certain types.

In the Chair: Matthias Groote (S&D, DE)