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C 76/56 EN Official Journal of the European Communities 11. 3.


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 (1).
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 (2). 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.

(1) OJ L 169, 12.7.1993.

(2) OJ L 210, 7.8.1985.

(98/C 76/139) WRITTEN QUESTION E-1803/97

by Robert Evans (PSE) to the Commission
(28 May 1997)

Subject: Hygiene checks on products entering the EU

Would the Commission confirm that it is the responsibility of the airport authority of the EU country of the first
port of call to carry out hygiene checks on shipments into the EU, even if this is not its final destination?
11. 3. 98 EN Official Journal of the European Communities C 76/57

Companies importing into the United Kingdom from within my constituency have experienced severe delays
when their shipments have not been checked at the first port of call and then further delayed, resulting often in
perishment for goods with a short life.

Answer given by Mr Fischler on behalf of the Commission

(25 June 1997)

As a general rule, according to Council Directive 90/675/EEC of 10 December 1990 laying down principles
governing the organization of veterinary checks on products entering the Community from third countries (1),
veterinary checks are carried out at the border inspection post situated at the point of entry into Community

However, Article 8(4) of the Directive states that by way of derogation for products entering one of the
Community territories via a port or airport, checks may be carried out in the port or airport of destination,
provided that this port or airport has a border inspection post and that the products are transported, as the case
may be, by sea or air. This possibility has been introduced in order to facilitate trade and cover the situation
whereby ships or aircraft only stop over in the first port or airport in the Community.

The Commission has not been made aware of any particular comments with regard to checks carried out at the
border inspection post at Heathrow airport.

(1) OJ L 373, 31.12.1990.

(98/C 76/140) WRITTEN QUESTION E-1832/97

by Jan Sonneveld (PPE) and Reimer Böge (PPE) to the Commission
(28 May 1997)

Subject: Canning of pigmeat from swine fever quarantine areas in the Netherlands

Because of the current swine fever problems in the Netherlands and the measures required as a result, financial
aid from the European Union is currently being used to buy up large numbers of pigs for destruction in the
quarantine areas.

There are three consequences:

− a considerable financial burden for the EU and the Netherlands,
− an increasing shortage of raw materials for the pigmeat processing industry,
− increasing social resistance to the waste of healthy pigmeat.

By canning this meat it will be possible to:

− save on the costs of buying up pigs,
− create alternative employment opportunities,
− prevent the waste of healthy pigmeat.

1. Does the Commission share the view that this meat satisfies all the conditions for human consumption?

2. Does the Commission agree with the advantages of canning as opposed to destruction, as set out above?

3. Is it true that the Commission has authorized the canning of meat from quarantine areas for Germany, but
not for the Netherlands?

4. If so, is the Commission prepared also to allow the Netherlands to can meat, and when?