The European Parliament,

–   having regard to the Commission communication (COM(2001) 666 – C5&nbhy;0327/2002),

–   having regard to Article 152 of the EC Treaty,

–   having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(1),

–   having regard to the European Parliament and Council Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices(2),

–   having regard to the European Parliament and Council Directive 2000/70/EC of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma(3),

–   having regard to its resolution of 13 June 2001 on the petitions declared admissible, concerning silicone implants (Petitions 0470/1998 and 0771/1998)(4),

–   having regard to Rule 47(1) of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Consumer Policy and the opinions of the Committee on Women's Rights and Equal Opportunities and the Committee on Petitions (A5&nbhy;0008/2003),

A.   whereas there is a lack of information on the potential risks of breast implants,

B.   whereas thousands of women have petitioned the European Parliament to take a stand on the dangers inherent in the use of silicone breast implants,

C.   whereas, in its resolution of 13 June 2001, the European Parliament focused in particular on the safety and quality of products and pre- and post-operative support, recommending a number of specific measures at Community and national level,

D.   whereas patients need to know that, in some cases, implants are not permanent and may need to be replaced or removed; whereas patients also need to be informed about implant quality and the suitability of implants for the patient concerned,

E.   whereas, according to some studies there is a significant rate of rupture from 5-51%, whilst other studies point to a rupture rate of 50% after 7-10 years and up to 95% after 20 years,

F.   whereas many women have implants for cosmetic purposes; whereas self-help groups argue that if more information on the risks and implications were given before surgery, fewer women would opt for implants,

G.   whereas lack of registration of implants in Europe results in the fact that the overall number of women with implants is unknown,

H.   whereas there are shortcomings in the existing research, e.g., lack of long-term data, no precise figures relating to the number of implants, the mixing of different implant types in studies and insufficient information about the durability of implants,

1.  Calls for the adoption and implementation of essential specific measures designed 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:

2.  Recommends that implants in women under 18 years of age should be authorised only on medical grounds;

3.  Seeks a guaranteed control over the marketing of breast implants, so as to avoid incorrect and misleading information;

4.  Underlines the need to facilitate consensus on, and to promote and support, effective surveillance systems to report adverse and long-term effects;

5.  Welcomes the fact that the Commission, with a view to addressing the many problems posed, has declared itself in favour of a Community&nbhy;wide policy, and has set out in its communication to Parliament, the Community and national provisions already applicable in this area;

6.  Welcomes 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;

7.  Supports 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;

8.  Considers silicone breast implants a health priority and requests that funds be made available in the EU research programmes, focusing specifically on the shortcomings of some of the research to date;

9.  Considers that the labelling of silicone-gel implants should include a warning of the potential health risks;

10.  Insists that before a date for a silicone-gel implant operation is agreed with a patient, she must be handed a copy of the patient information and advice sheet drawn up by the relevant national authority (e.g. the formula proposed by EQUAM) containing a warning of potential health risks; this should, moreover, contain a recommendation urging that an operation should only be agreed to after all outstanding questions have been unambiguously settled;

11.  Welcomes the Commission proposals to facilitate consensus on a breast implant consent form, including information relating to alternatives, benefits and risks;

12.  Calls for the introduction of an implant recipient's passport in which the special characteristics of the implant and post-operative follow-up care measures are specified; the passport must be signed by the surgeon and the patient, and be valid as a consent form for the operation;

13.  Believes that all potential patients should have access to free, comprehensive information drawn up by independent experts and points out that doctors and nurses have a particular responsibility to provide reliable, objective, complete and scientifically up-to-date information on all the details of implants (identification number, volume and type) in writing and in language the patient can understand; considers that they also need to be involved after the operation, to facilitate future care; calls on the Member State authorities to lay down standards for the provision of information;

14.  Takes the view that it is necessary to raise general public awareness of the potential risks of silicone-gel breast implants; in particular, women should be aware that in some cases, breast implants have to be replaced after a period of time that varies from person to person; women, including young women, should be comprehensively and appropriately informed that adverse effects or genotoxic risks in the event of pregnancy or for nursing mothers cannot be completely excluded;

15.  Calls for a compulsory annual follow-up examination, the results of which should be made available for research and further development in the interests of patient safety and implant-toleration;

16.  Recognises that patients who have already received breast implants may need retrospective information, advice and medical supervision, screening for cancer and for intra- and extra-capsular rupture; points out that for this purpose the use of medical imaging techniques such as scanning, magnetic resonance and echography help surveillance and the accuracy of diagnosis;

17.  Recommends the fostering of tolerance and self-esteem and other conceptual alternatives to breast implants, in collaboration with active groups in this field;

18.  Urges Member States to concentrate on promoting and securing acceptance of a realistic image of women by running positive information campaigns, rather than allowing unregulated advertising practices to impose an ideal conception of beauty as the norm;

19.  Calls for the alternative operative methods of maintaining breast structure by using the body's own tissues to be made better known and more widely promoted;

20.  Points out that where Member States apply minimum age limits for the implantation procedure, reconstructive surgery on medical grounds is sometimes necessary at an earlier age;

21.  Urges Member States to ban, following the example set by France, the direct advertising to the general public of breast implants or breast implant operations (surgical treatment) and, instead, to disseminate objective, non-commercial information through national public health services, in particular - but not exclusively - on the Internet; in any case, in order to avoid incorrect and misleading information, there is a need to regulate advertising in some Member States, which is fuelling demand for implants, without providing any balanced information; proposes that advertising of "cosmetic surgery" breast implants should contain a statement stipulating that relevant information is available and should also carry clear, bold health warnings;

22.  Urges that "Before and after" pictures should not be used in such advertisements;

23.  Urgently recommends that details of breast implant operations should be recorded in the EU in the form of a compulsory National Breast Implant Registration in each Member State; calls on Member States to subscribe to the International Breast Implant Register (IBIR) and to assume the costs incurred for national subscription to the international register;

24.  Considers that national breast-implant registers are an essential means of enabling both producers and patients to be traced (in the event of defective implants being identified they will, in particular, be essential in tracing the patients concerned after the operation); points out that every effort will have to be made in that connection to ensure compliance with existing provisions on protecting personal privacy in the processing of personal data, and that access to the registers will have to be restricted and their contents treated as confidential;

25.  Proposes that manufacturers should only supply to surgeons who are included in the European register; an independent monitoring body should monitor this and the results of the monitoring should be published;

26.  Also calls for a sound certification procedure for practitioners, so as to reduce the damage to health as a result of incorrect operations;

27.  Considers that, together with the liability of manufacturers of implants, guarantees for patients in respect of surgeons and clinics should be laid down;

28.  Suggests that the cost of breast implants should include the following: a meeting before the operation with the surgeon involved; clear informed discussion of the implications of breast implant operations, as well as the alternatives available, with a properly trained and accredited independent counsellor with no financial interest in the patient's final decision; a cooling-off period of no less than four to six weeks; detailed pre-implant case history; post-implant counselling and periodic reviews;

29.  Believes 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;

30.  Urges the Member States to carry out thorough and frequent inspections, particularly in the case of private clinics that perform breast implant operations, using national/regional public health inspectors;

31.  Calls on the Commission to undertake a review of national measures adopted in relation to this Communication within three years;

32.  Instructs its President to forward this resolution to the Council, Commission and the parliaments of the Member States.

(1) OJ L 169, 12.7.1993, p. 1. (2) OJ L 331, 7.12.1998, p. 1. (3) OJ L 313, 13.12.2000, p. 22. (4) OJ C 53 E, 28.2.2002, p. 231.