By Dr. Martin Schoelkopf
In mid-February, the Commission presented a report on the activities undertaken by the Member States concerning the safety of breast implants. This particularly refers to the accessibility of information, rules on consent for female patients, the advertising of breast implants, and reflections in terms of the generation of national registers and long-term follow-up monitoring. The report follows on from a Communication of the Commission (November 2001) on the same topic, in which a series of measures was proposed for improving the quality of breast implants and patient protection.
In parallel to the report, the Commission presented its proposal for a Directive on better classification of breast implants. In the tightening of rules on quality and safety checks, a special certificate will have to be issued for all implants, documenting adherence to those rules. In addition, the Commission has asked the European Committee for Standardisation to examine the current European standard regarding breast implants. Report and further details: http://europa.eu.int/comm/enterprise/medical_devices/index.htm.