Commission calls for further research into breast implants
The European Commission has adopted a communication recommending that further research and development (R&D) is carried out into the possible side effects of breast implants. The recommendations were drawn up following consultations with the European Parliament and national authorities. They form part of a continuous search for improvement in the clinical performance of breast implants include the following: - Member States are invited to examine the need and possibility of setting up national registers for breast implantation that should constitute the basis for traceability and long term research on breast implants. - Before breast implants are placed on the market, manufacturers must collect clinical data on the characteristics and performance of the product. - Once breast implants have been either placed on the market or implanted, manufacturers must maintain a systematic procedure to review experience gained from devices in the post-production phase including prospective clinical evaluations as well as implementing appropriate means to apply any necessary corrective action. - Member States should take steps to ensure that any 'incidents' are recorded and the relevant information is evaluated centrally. Data obtained will be part of a European database currently being set up. - Long term secondary effects should be monitored. The Commission is inviting Member States to verify with the medical profession mechanisms under which such monitoring can best take place. - The Commission will regularly discuss the outcome of national studies in expert meetings with national authorities and manufacturer