Madam President, I wish to thank everyone who has contributed to this debate. Throughout this process there has been a lot of consensus and, for a change, most colleagues agree that action needs to be taken. That is why I accept all three amendments which have been tabled to this report. How did we get to this stage? Over eight years ago a woman called Margot Cameron attended a surgery held by my colleague, Mr Miller. She said that nobody would listen to her. Her story so inspired my colleague that a petition was lodged with the European Parliament which showed that Margot was not alone. There are many Margots in the UK and across the EU with similar stories concerning problems with silicone. The petition has led to the Commission reclassifying breast implants as a Class III product under the Medical Devices Directive 93/42/EEC. Member States are to adopt and publish laws, regulations and administrative provisions necessary to comply with this directive no later than 1 August 2003. If I am not mistaken, this is the first time that such a petition has led to direct action by the Commission. I hope that more and more EU citizens will find solutions to their problems through this route. However, much as Parliament welcomes the Commission's actions, we would like to take this matter still further. As more women choose to have implants - whether for purely cosmetic reasons, reconstruction after breast cancer or breast deformities – we must ensure that people make informed choices and we must put patient safety first. My report aims to answer both the legitimate concerns of thousands of women and the need to put patient safety first. Therefore, the report recommends Member States to take measures to increase and improve information for patients through tracking and surveillance, quality control and assurance. In this perspective, I particularly want to emphasise three main points. Firstly, the need for responsible advertising. This includes all forms of direct advertising, such as in magazines and the use of 'before and after' pictures. We must clamp down on this misleading advertising that is fuelling demand and which many women pin so much hope on. Perhaps 'before and after' photographs of women who have suffered from ruptured implants would tell a very different side of the story to the readers of glossy magazines. I would like to see the 18-year age limit applied – apart from where there is medical need – in order to protect young women from making ill-informed beauty choices. Secondly, the need for information requires proper labelling and marketing, including health warnings explaining the health risks involved. For instance, women should be aware that breast implants will have to be replaced after a time period. It is a grave state of affairs that for too long cosmetic cowboys have got away with not explaining these simple facts. It is for this reason that we require the creation of an international register of accredited plastic surgeons. Finally, there must be responsible research. Before breast implants are placed on the market, manufacturers must collect clinical data on the characteristics and performance of their product. It also means that breast-implant producers need to trace their products. Therefore, the creation of a national breast implant registration to keep women informed in the event of a product fault is vital. This issue will not go away. I hope that in the future more women will be able to make informed choices and they will not have to suffer in the way that so many women like Margot have in the past. I hope that the Commission will be able to report back to Parliament on how far the Member States have gone in implementing this reclassification, and will continue to monitor the issue of silicone-gel breast implants, always putting patient safety first. IN THE CHAIR: MR DAVID MARTINVice-President

Political group: PSE