Brussels, 10/01/2012 (Agence Europe) - MEP Françoise Grossetête (EPP, France) is appalled by the scandal over the breast implants produced by French company PIP (Poly Implant Prothese), which is based in her European constituency of La Seyne-sur-Mer. She stresses that people in the health sector must conduct themselves in a manner that is above reproach and welcomes the increasing attention being directed by the European institutions at fraud in this area. Thus, the review of the directive on medical devices which the European Commission is due to bring forward in the course of the first half of this year comes at just the right time. Grossetête says that “it is absolutely essential that traceability and exchange of information on medical devices among states is improved”, following the scandal where PIP breast implants, using industrial-grade silicone, have split. She says that there has to be a Europe-wide marketing authorisation for medical devices, as is currently the case for medicines. Alongside this, there should be monitoring and more in-depth checks following marketing.
In similar fashion, Eucomed, the European medical technology industry association, has expressed great concern at the fraud, should accusations prove to be founded, by the French company. “Patient safety, public confidence and ethical behaviour should always be the top priorities of any organisation active in the healthcare industry”, it says in a press release. The current European directive on medical devices provides a high level of product safety but, unfortunately, cannot prevent cases of deliberate fraud or abuse. That is why Eucomed supports more effective measures to prevent a similar case happening in future. In view of the review of the directive, Eucomed has submitted proposals that would strengthen and modernise the current system. It says that change should be achieved by enhanced member state engagement with better science-based coordination and management of the regulatory system at European level. (IL/transl.rt)