Breast implants scandal: never again!

"Since the Poly Implant Prothese (PIP) breast implant scandal was revealed, thousands of women around the world have been living a nightmare, not knowing whether their lives are at risk or not. The PIP firm has sold its breast implants in 71 countries around the world. Up to 87,500 women are believed to have been given transplants in France, the United Kingdom, Spain and Germany. The various health and safety issues pertaining to these controversial implants have far-reaching implications", said Philippe Juvin MEP and Thomas Ulmer MEP today, following the vote on a Resolution on the PIP breasts implants in the Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament.

"Members of the ENVI Committee have unanimously decided to send a clear signal to the European Commission asking for stricter rules in order to prevent such a scandal from ever happening again", said the two MEPs, co-signatories of the Resolution for the EPP Group.

"The PIP controversy has shed light on several inconsistencies in the current legislation on the traceability and market surveillance of medical devices and on the monitoring of Notified Bodies*", explained Philippe Juvin MEP.

"Therefore, in the Resolution adopted today, we are suggesting two measures for the European Commission to take: on the one hand, strengthen surveillance of those medical devices carrying potential risks already on the market and, on the other, to tighten up criteria upon which Notified Bodies are designated", explained Thomas Ulmer.

"At the moment, lamentably, there is no European guidance on the designation of Notified Bodies, or on the audits they carry out. But to create safe medical devices for the internal market, it is essential to harmonise standards and therefore to have an EU-wide agreement on accreditation criteria, pre-market requirements and post-market surveillance", added Philippe Juvin.

"Inspections by Notified Bodies are also crucial. They should be mandatory, frequent and unexpected. Finally, we call on the European Commission to increase information-sharing between Member States on both the traceability and conformity of medical devices", said the two MEPs.

"We have to balance the fight against fraudulent medical practices and patient safety against medical research and innovation so that the European Union stands for a competitive and innovative internal market that ensures public health and safety", Philippe Juvin and Thomas Ulmer concluded.