Brussels, 02/02/2012 (Agence Europe) - It would seem that women fitted with PIP faulty breast implants do not run risks that are any higher than those for women with other kinds of breast implants. This at any rate was the main conclusion reached by the scientific report published on 2 February by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), at the behest of the European Commission. The report therefore confirms conclusions reached in a report published the previous day by the French authorities (see EUROPE 10544). The Commission has nonetheless called on the scientific committee to conduct further in-depth study. Frédéric Vincent, the spokesman for Health Commissioner John Dalli, warned that experts had worked under pressure with just a few weeks to complete the study on the basis of data sometimes difficult to collect and compare. The major problem facing experts is that silicon analysed may differ considerably from one batch to the next, and from one year to the next.
The Commission is to continue discussion with member states. A fourth meeting of the Health Security Committee was scheduled for Thursday 2 February, during the afternoon. Member states are currently assessing the medical consequences to be drawn, in particular whether faulty implants should be removed or not. At this stage, five countries have suggested implants should be removed - France, Germany, the Czech Republic, the Netherlands and Belgium. The European directive on medical devices now allows security to be strengthened at European level and the role of member states is crucial as greater surveillance on national territory is required (before and after marketing of the product). In the context of review of the directive, the Commission is finalising a list of measures for more stringent application of the directive, a list that will be discussed over coming weeks. It has also initiated a “stress test” to see what answers should be given to questions raised by the breast implant scandal during review of the directive. Several courses of action are being explored, especially the method for designating the notifying bodies and those authorising marketing of the implants (EC marking), greater cooperation between surveillance and vigilance bodies once the product is on the market, and the traceability of medical devices. It would be ideal, after the example set by Denmark, for each member state to have a register of medical devices for operations that have taken place on its territory, which, in the case of the PIP implants, would have allowed persons receiving implants to be identified, Frédéric Vincent said. Finally, another avenue proposed by the Commission is the creation of a unique device identifier (UKI), a unique identifier placed on devices (for example in the form of a microchip). The Commission intends to put this proposal forward, probably in the spring, in the form of a directive or regulation. (IL/transl.jl)