Select Committee on European Scrutiny Fourteenth Report




COM(01) 666

Commission Communication on Community and national measures in relation to breast implants.

Legal base:
Document originated:15 November 2001
Forwarded to the Council:15 November 2001
Deposited in Parliament:5 December 2001
Basis of consideration:EM of 13 December 2001
Previous Committee Report:None
To be discussed in Council:No date set
Committee's assessment:Politically important
Committee's decision:Cleared


  13.1  Breast implants fall within the scope of the Medical Devices Directive (93/42/EC),[41] which requires manufacturers to meet certain safety and performance criteria before a product is placed on the Community market. Despite this, concerns over the possible adverse effects of implants resulted in two petitions being presented to the European Parliament in 1998 calling for an immediate ban on silicone-gel filled implants. This led the Parliament to set up a Scientific Technological Options Assessment, and, although this did not find any evidence of a link between disease and such implants, it did note that problems occurred, mainly because of the design and characteristics of the product. The Commission says that this in turn has resulted in a widely accepted consensus that Community-wide measures were needed to improve information for patients, tracking and surveillance, quality control and assurance, and key research. According to the Commission, the present Communication provides a follow-up to that consensus, and sets out the various measures which it believes should be taken.

The current document

  13.2  The measures recommended fall under the following headings:

  • Essential safety requirements

The Commission says that, in order not to compromise the safety or health of recipients, manufacturers must fulfil a number of safety requirements, including a pre-market risk analysis to identify known hazards and to eliminate or reduce these as far as practicable. They must also submit design specifications to a notified body for evaluation, with the data concerned being taken into account in the risk analysis. These steps must be complemented by post-market surveillance, and the provision of instructions.

  • Informed patient consent

The Communication says that, given possible side effects, technical requirements are not in themselves sufficient to provide the best guarantee of health protection, and that Member States should ensure that women contemplating breast implants are adequately informed about the associated risks, so that they can compare these with their own personal assessment of the benefits. There should also be a requirement for any advertising to provide balanced information, and to include a suggestion that independent advice should be sought.

  • Research and development

The Commission highlights the importance of increased knowledge of the short and long-term effects of breast implants on health. It says that, in addition to the collection of pre-market clinical data, this should involve manufacturers keeping up to date a systematic procedure to review experience, and notifying the competent authorities of any incidents (with the data obtained in this way forming part of a European database). It also suggests that Member States should verify with the medical profession the mechanisms needed to monitor over a long period the health of women who have received implants, and that they should examine the possibility of setting up national registers for breast implantation which would then constitute a basis for traceability and long term research.

The Government's view

  13.3  In his Explanatory Memorandum of 13 December 2001, the Parliamentary Under-Secretary of State at the Department of Health (Lord Hunt of Kings Heath) says that the UK has already adopted most of these recommendations, and that further work is already under way on those outstanding, notably to ensure that notified bodies and manufacturers are aware of the Communication and of their responsibilities under it. He adds that patient information for women considering implants is being re-assessed to see if it needs to be revised.


  13.4  We note this Communication, and the extent to which its recommendations are currently being implemented within the UK. In view of this, we are clearing the document, but, in doing so, we think the subject is of sufficient importance to draw to the attention of the House by means of this brief Report.

41   OJ No. L.169, 12.7.93. Back

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