Breast implant fears spark Brussels crackdown

Following the publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company on the 2 February 2012, the European Commission has requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The European Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a 'stress test' of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012.

Other news sources suggest that the European Commission aimed to strengthen oversight of companies that certify medical devices following the breast implant scandal thought to have affected at least 400,000 women worldwide.

European Commission: RAPID: Press Release, IP/12/96: Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants http://europa.eu/rapid/pressReleasesAction.do?reference=IP/12/96&format=PDF&aged=0&language=EN&guiLanguage=en

European Commission: DG Health: Public health: Medical devices: Regulatory framework http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

Deutsche Welle, 1.2.12: Italian surgeons sue PIP and German health certifier over breast implants http://www.dw-world.de/dw/article/0,,15707550,00.html

EUObserver, 2.2.12: Breast implants scandal set to lead to tougher EU legislation http://euobserver.com/22/115113

ESO: Background information: EU evaluates danger, number of faulty breast implants http://www.europeansources.info/record/eu-evaluates-danger-number-of-faulty-breast-implants/

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