Commission Communication on Community and national measures in relation to breast implants.
|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
13.1 Breast implants fall within the scope of the Medical
Devices Directive (93/42/EC),
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
- 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.
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.
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.
OJ No. L.169, 12.7.93. Back