Brussels, 25/04/2012 (Agence Europe) - On 25 April, the European Parliament's committee on the environment and public health (ENVI) adopted a resolution by 62 votes on the subject of breast implants produced by the French company, PIP. The resolution was jointly signed by Philippe Juvin (EPP, France) and Thomas Ulmer (EPP, Germany). It calls for mechanisms to be set in place in order to trace medical devices and to ensure the long term follow-up on the safety and effectiveness of those devices. Such mechanisms could include specific identification systems, implant registers, and a product characteristic summary for every medical device. It is also requested that bodies notified should be able to make full use of their powers to carry out frequent on-the-spot unannounced inspections at least once a year, throughout the supply chain (at least for medical devices that present high risk potential). Juvin and Ulmer said: “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 every happening again”.
MEPs regret the fact that, at present, there is no European guidance on the designation of notified bodies, or on the audits that these bodies carry out. Michèle Rivasi of France, who is vice-president of the Greens Group and a co-sponsor for the resolution, pointed out that: “The case of PIP implants, like that of hip replacement prosthesis, have highlighted the failure of the current certification system and controls carried out by the notified bodies”, as no authorisation is required for the marketing of such products. She also supported the idea of calling on the Commission to demand an appropriate toxicological assessment of all medical devices and to suggest the gradual phasing out of the use of substances that can prove carcinogenic, mutagenic or toxic for reproduction. (IL/transl.jl)