Wat is er met de resolutie van 2001 gedaan?

Achteraf komt het erop neer, dat borstimplantaten in controle klasse lll kwamen, maar dat die controle niets om het lijf had. Ze kregen gewoon een CE markering; een papieren controle dus.Hierdoor konden fabrikanten gewoon doorgaan met hun productie en verkoop.

Deze geweldige voorstellen werden niet gebruikt; >>

  • geen registratie
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  • geen bezinning periode
  • enzovoorts.

Na onze vraag aan het ministerie van VWS: Wat is er met de resolutie van 2001 gedaan, kregen wij dit antwoord:

Following petitions introduced in 1998 by groups of women against the use of silicone breast implants, the European Parliament published a study on the health risks posed by silicone gel breast implants . In reaction to this study, the Commission, the European Parliament and all national authorities reached consensus in favour of a Community wide policy under which silicone breast implants would not be banned, but specific measures would be introduced to improve the quality/safety of implants and the information of women. This political consensus was laid down in the Commission Communication of 15 November 2001 Communication on Community and National Measures in relation to Breast Implants .

The Communication makes a sharp distinction between measures at community level and those to be taken at national level.

Measures at Community level mainly deal with breast implants as a medical device covered by the directive 93/42/EEC on medical devices. Based on point 2 of the Communication, the Commission adopted two main measures; the reclassification of breast implants from class IIb to class III and a mandate to the "Comité Européen de Normalisation" (CEN) requesting to revise the standard EN 12180-2000 in order to adapt it in the light of the Communication.

By its directive 2003/12/EC on reclassification of breast implants, the Commission in derogation to the provisions of Annex IX to Directive 93/42/EEC, classified breast implants in Class III . This classification reinforces the risk assessment procedure to breast implants by imposing under the conformity assessment procedure based on quality assurance, a design dossier examination leading to an EC design - certificate to each product. In the meantime, all the Member States have notified the text transposing this directive into their national law.

Mandate to CEN, the "Comité Européen de Normalisation" to review the European standards.

It has been recognized that the earlier standard EN 12180-2000 on Mammary implants, developed by the Comité Européen de Normalisation (CEN) was not sufficient to address the conclusions reached between the Commission, the European Parliament and national authorities. This standards was therefore withdrawn and is in the meantime replaced by EN ISO 14607:2009, Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007).

The Communication invited Member States to adopt a number of measures related to breast implantation (as opposed to breast implants). These measures relate to matters of national competence falling within the ambit of article 152 of the Treaty. Since then, each Member State has taken action, although to different degrees.

Based on information received, the Commission published a Staff Working Document on national measures adopted or envisaged by the Member States