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Image header Agence Europe
Europe Daily Bulletin No. 8092
Contents Publication in full By article 10 / 44
GENERAL NEWS / (eu) eu/health

Commission defines safety, information and surveillance requirements for breast implants

Brussels, 15/11/2001 (Agence Europe) - Seventy-five to 80% of breast implant surgery carried out in Europe is done for cosmetic reasons, and the remainder for medical reasons. A recent report from the European Parliament confirmed the lack of scientific evidence on a link between disease and silicone gel breast implants. It noted, however, that problems do occur, mainly because of the design and characteristics of the product, and mainly due to: (1) bleeding (the diffusion of small molecules of the liquid component of silicone through the intact shell); (2) capsular contracture (shrinkage of the fibrous capsule, notable as an apparent hardening); and (3) rupture of the shell (phenomenon that can be due to handling and trauma). The Commission, the European Parliament and the national authorities recently reached broad consensus on the need to tackle the problem at Community level by using the existing legal framework while introducing specific measures to strengthen and improve patient information, follow-up and surveillance, quality control of implants, and also key research. It was in the wake of this consensus that the Commission adopted, on Thursday, a communication that defines the provisions to be taken at Community and national level. These cover the requirements relating to the implants themselves as well as to the accompanying measures that are necessary to ensure an adequate level of health protection. The Commission above all proposes stricter controls on the safety of implants, strengthened measures aimed at ensuring compliance with this provision as well as improved European standards relating to breast implants. The text of the communication can be consulted at: http: //europa.eu.int/comm/enterprise/medical_devices/com2001_666/com_2001_666_final-fr.pdf

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