PIP 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 MEPs Philippe Juvin and Thomas Ulmer today, after the adoption of a Resolution by the European Parliament at its plenary session on defective silicone gel breast implants made by French company PIP.

"The European legislation on medical devices will be revised in September 2012. In this perspective, the European Parliament has 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.

"First, we urge the Commission to make inspections by Notified Bodies* mandatory, frequent, and unexpected. These inspections should take place at every stage of the 'life' of a high-risk medical device", said Philippe Juvin MEP.

"Moreover, it is essential to define European guidance on the designation of Notified Bodies, or on the audits they carry out. Therefore, we call for an EU-wide agreement on accreditation criteria for these bodies, and on their precise role", Thomas Ulmer MEP underlined.

"We also must strengthen the current legislation on the traceability and monitoring of medical devices and facilitate notification by patients and medical professionals of unwanted effects", underlined Philippe Juvin.

"We call on the European Commission to take our proposals into account when revising the Directive on Medical Devices. The security of European patients is at stake", concluded the MEPs.