Strasbourg, 14/02/2003 (Agence Europe) - With the adoption of the report by British Labour member Catherine Stihler, the European Parliament approves the broad lines of the Commission's communication on the Community and national provisions applicable to breast implants. It hopes, however, that the rules concerning these implants will be strengthened in order to guarantee their safety. Measures the Parliament would like to see brought in include: - ban on direct advertising (on the French model) and the provision of full information for women so that they may weigh up the advantages and the disadvantages of this kind of operation; - a ban on operations for purely aesthetic reasons before the age of 18; - the creation of national registers and a Community register in order to ensure that implants may be traced; - and the introduction of a passport for the bearer of implants in which the specific characteristics of the implant and the post-operation follow-up measures are specified (PES amendment).
During the debate, Ms Stihler mainly insisted on the need to ensure safety, quality and the traceability of the devices while allowing well-informed consent on the part of patients to an intervention which must be followed up with suitable medical surveillance. French national Janelly Fourtou (EPP-ED) stressed the responsibility not only of surgeons and clinics but also of manufacturers of implants. She expressed support for the PES amendment, which proposed bringing in a passport. German Social Democrat Karin Jöns recalled that 80% of these interventions are motivated by aesthetic reasons and that they may cause problems. It is therefore necessary for women to be suitably informed and to be able to benefit from adequate post-surgery follow-up, she said, mainly stressing the need to ensure specific training of aesthetic surgeons for this kind of operation. Belgian Liberal Frédérique Ries expressed his group's support for the recommendations contained in the report, but was opposed to bringing in registers and a passport as she felt this would be excessive, as such measures do not exist for more important interventions, such as cardiac surgery. Evoking the operations performed in a hairdressers' on the Canary Islands, Laura Gonzalez Alvarez (GUE, Spain) urged for stringent controls to be brought in to verify the conditions in which such operations are carried out. Alleanza nazionale member Antonio Mussa noted various studies that demonstrate the fact that silicon implants are harmless, that they are well tolerated and last on average about 20 years. In his view, there is no reason not to use them, except among young women under the age of 18. He did, however, take a stance in favour of bringing in national and European registers and the possibility for women to receive annual check-ups after such surgery.
Commissioner David Byrne pointed out that the Commission has received encouraging information from Member States since its communication was adopted in 2001, and that it plans to apply stricter provisions (quality and safety requirements) under category III for breast implants (currently, implants are in category IIB of the directive relating to medical devices). The Commission will present measures that fully comply with what the Parliament has requested, he added.