Health protection: breast implants, Community and national measures

The European Parliament adopted a resolution based on the report by Catherine STIHLER (PES, UK) on the Commission Communication. (Please refer to the summary of 22/01/03.) Parliament welcomed the fact that the Commission has adopted virtually all of Parliament's suggestions, particularly with regard to advertising, the information required to be given to patients, the greatest possible guarantees of the quality of implants and the keeping of national registers. It called for the adoption of specific measures to improve information provided to patients, tracking and surveillance, quality controls and quality guarantees, key research on silicone breast implants and their components, and on their clinical evaluation after they are placed on the market, in particular in relation to: - the life span of implants; - methods of improving the protection of the recipient's health; - a full assessment of the health implications and risks; Parliament supported the proposed reclassification of implants as a Class III product under Directive 93/42/EEC, as this will have the welcome effect of reinforcing assessment procedures. It considered silicone breast implants a health priority and requested that funds be made available in the EU research programmes, focusing specifically on the shortcomings of some of the research to date. The labelling of silicone-gel implants should include a warning of the potential health risks. The European Parliament went on to state that there must be comprehensive international lists of specialist medical practitioners in plastic surgery and that this specialist area must, moreover, extend to breast implant surgery and include expertise in the removal of old and defective implants. Member States are asked to ensure that frequent inspections are carried out, particularly in the case of private clinics that perform breast implant operations, using national/regional public health inspectors. The Commission is asked to undertake a review of national measures adopted in relation to this Communication within three years.�