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European Parliament vote: PIP scandal calls for strong EU action

14 June 2012
by BEUC -- last modified 14 June 2012

Today, the European Parliament voted a resolution on the PIP breast implants scandal which affected 400,000 women around the world and more than 100,000 women in Europe. The PIP case illustrates the failure of the current system to guarantee consumer safety and the urgent need for a major revision of EU legislation on medical devices in order to restore public trust.


BEUC  strongly supports that the European Parliament asks for the introduction of a system of pre-market authorisation for high risk devices (such as pacemakers) and welcomes its recommendations to reinforce market surveillance, give consumers the possibility to report adverse events, improve the traceability of the device and enhance coordination among Member States.

Monique Goyens, BEUC Director General said:

"Health authorities across Europe failed to give consistent information what to do about defective PIP implants. Some Member States advise to monitor the situation while others recommend the removal. This creates a lot of confusion and anxiety for thousands of women. Consumers should be provided with better information regarding the risks associated with cosmetic implants and the fact that they might need replacement after a period of time.

"MEPs rightfully acknowledged that the PIP fraud is another example for the need of a collective redress system which allows consumers to defend their rights and obtain compensation for the damage they suffered.

"Implants are not like a cheap watch you can throw away if it breaks. It is crucial that implants go through a thorough clinical evaluation to prove their safety and efficacy before being placed in a human body."

BEUC, The European Consumer Organisation has a membership of 42 well respected, independent national consumer organisations from 31 European countries (EU, EEA and applicant countries). BEUC acts as the umbrella group in Brussels for these organisations and its main task is to represent its members and defend the interests of all Europe's consumers.

BEUC, the European Consumers' Organisation