Brussels, 05/01/2012 (Agence Europe) - The European Commission has proposed a common risk assessment system for risks relating to breast implants, further to a meeting of the Health Security Committee on Wednesday 4 January, and to the scandal caused by substandard implants manufactured by the French company, PIP. In coming months, the Commission will unveil a proposal for revision of the directive on medical devices, in order to improve product safety and increase the exchange of information between member states.
For several weeks now, member states have been discussing the safety of breast implants, at France's request. A first meeting of the Health Security Committee was held before the Christmas break and earlier this week, and member states are exchanging details of their risk assessments on the matter, Frédéric Vincent, the spokesman for Health Commissioner John Dalli, confirmed on Thursday 5 January. After Wednesday's meeting, the United Kingdom announced its intention to publish its own conclusions. The Commission will, moreover, present a proposal at the end of the first half of 2012, aimed at revising the 2007 directive on medical devices. One of the aims of that revision is to step up the traceability of products and intensify information exchange between member states. The directive currently lists over 10,000 medical devices ranging from contact lenses to bandages. Breast implants are in category 3, under greatest surveillance. The Commission is seeking to step up product traceability and safety, especially for category 3 products, so that it is possible to follow the product through from manufacture to the end-user. This requires strengthening approval issued by national authorities for certifying the product, the spokesman said. Member states are responsible for carrying out health controls on medical appliances and for attributing the EC label if, after examination, the products are found to be in line with European standards. The Commission has also suggested setting a common risk assessment system in place for breast implants, in the form of common questionnaires to be filled in by those using PIP implants.
The French health authorities withdrew implants manufactured by the French company PIP in March 2010 after plastic surgeons had raised the alarm. Surgeons had expressed concern at the high number of implant ruptures. It has come to light that PIP used an adulterated industrial silicon for the implants instead of medical silicon, and this is believed to be the cause of the tendency to rupture. The Commission has confirmed that it has been informed of investigations currently underway at national level but has not wished to comment so far. It is now seeking to determine how many women throughout the world have received PIP implants. In the United Kingdom and France alone, some 80,000 women are fitted with such implants (40-50,000 for the United Kingdom and 30,000 in France). According to Frédéric Vincent, tens of thousands of the implants have been exported to third countries, with the company PIP being the largest producer of breast implants worldwide. In France, two cases of cancer have occurred among those wearing the implants but it has not been established whether the implants were the cause of the cancer. The French government has nonetheless advised the women concerned to have the implants removed, until more is known. (IL/transl.jl)