WRITTEN QUESTION P-1793/97 by Heidi Hautala (V) to the Commission (16 May 1997)

Subject: Health risks of silicone implants

According to recent research silicone implants, generally inserted to increase the size of women's breasts, may leak silicone into the body, which can result in very serious damage to health. Silicone is also thought to migrate to the foetus in pregnant women, with serious consequences.

In the USA a number of court cases with far-reaching implications are under way against the manufacturers of silicone implants, which may result in the authorities banning such implants.

Is the Commission aware of the serious damage to health caused by silicone, and in particular of the claims that silicone may migrate to other parts of the body and to the foetus? Is the Commission considering measures to tighten the product liability of silicone implant manufacturers? Does the Commission intend to ban them?

Supplementary answer given by Mr Bangemann on behalf of the Commission (4 September 1997)

Further to its answer given by Mr Bangemann of 12 June 1997, the Commission is now able to provide the following additional information.

The Commission is aware of the discussion on the safety of silicone gel-filled breast implants. These products are regulated as medical devices by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ((OJ L 169, 12.7.1993. )). They are used for breast reconstruction or breast augmentation. Implantation of breast implants may imply certain risks which may be associated with the implants and with the required surgery.

In the context of the implementation of Directive 93/42/EEC the issues of safety and of certification of silicone breast implants were discussed on several occasions between the Commission and Member States. In France and the United Kingdom available scientific literature on risks related to silicone gel-filled breast implants was reviewed in 1994 and 1996 by independent scientific experts. Results of these reviews confirm that the different studies on the incidence of connective tissue disease in women with silicone gel-filled breast implants did not show any appreciable difference from that in the unimplanted population. It is, however, well established that all kinds of breast implants, independently from their filling material, can present side effects such as the formation of capsular fibrosis.

The different safety-related features of breast implants including biocompatibility, mechanical properties, migration of the filling and shell material, compatibility between shell and filling material, ageing, stability and labelling are currently under examination within the European committee for standardisation (CEN) and within a special working party of certification bodies in charge of certification of these products on the basis of Directive 93/42/EEC. Relevant standards and guidance documents under preparation aim at ensuring a high level of protection of patients receiving such implants.

Due to residual risks which, as in the case of other implants, cannot be entirely excluded (i.e. capsular fibrosis or other local complications) and in view of possible complications related to the implantation, it is important that patients are adequately informed about possible problems. The establishment of a detailed protocol and consent formis currently being prepared by the European professional organisation of physicians EQUAM (European committee on quality assurance and medical devices in plastic surgery). This document, on which patient representatives are also being consulted, will help to improve the information available to patients.

The Commission will keep under review the issues related to the safety of these products together with Member States. The results of currently available scientific reviews do not justify prohibition of such implants. Directive 93/42/EEC should therefore adequately ensure the safety of these products.

Liability of the producers of silicone implants is regulated by Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products ((OJ L 210, 7.8.1985. )). The general application of this measure will be assessed by the Commission in order to prepare its second report to the Parliament and the Council.