91998E1821

WRITTEN QUESTION P-1821/98

by Doeke Eisma (ELDR) to the Commission

(3 June 1998)

Subject: Ban on use of silicone breast implants

1. Does the Commission believe that the use of silicone breast implants is dangerous?

2. If so, what measures will it take to control the use of such implants?

3. Which Member States have banned the use of silicone breast implants or are preparing measures to do so?

Answer given by Mr Bangemann on behalf of the Commission

(1 July 1998)

1. and 2. The Commission is aware that the use of silicone and other breast implants presents certain risks.

With a view to controlling these risks as well as possible, the Commission is finalising guidelines for conformity assessment procedures for breast implants within the framework of Directive 93/42/EEC of 14 June 1993 concerning medical devices(1).

The Commission would also refer the Honourable Member to its answer to question P-1793/97 by Mrs Hautala(2).

3. France authorises the use of breast implants filled with physiological saline and other types of breast implant bearing the EC mark, provided that they have been specifically assessed in France in accordance with French rules.

France has invoked the safeguard clause included in Directive 93/42/EEC for the products in question. The Commission is examining the case.

The Commission has discussed the subject several times with all the Member States and as far as it is aware none of the other countries have taken restrictive measures similar to those taken by France.

(1) OJ L 169, 12.7.1993.

(2) OJ C 76, 11.3.1998, p. 55.