The breast implant scandal and European medical device regulation

GMP Review

Volumn 11, Issue 1, 2012, Pages 4-6

  Donawa, Maria ^a   Gray, Roger ^a  

^a VP Quality and Regulatory of Donawa Lifescience Consulting   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

SILICONE;

BREAST ENDOPROSTHESIS; EUROPE; HUMAN; LAW ENFORCEMENT; REVIEW;

EID: 84861523985     PISSN: 14764547     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (8)

1. Afssaps information sheet, Silicone gel breast implants from Poly Implant Prothèse Company - Information (15 July 2010); www.afssaps.fr/var/ afssaps-site/storage/original/application/63285b895bc9b60c15a7743e08432dc1.pdf
2. Afssaps website, Information for women with PIP breast implants-Questions/answers (26/7/2010); www.afssaps.fr/Afssaps-media/ Publications/Information-in-English
3. Afssaps report, Topical report on PIP silicone gel-prefilled implants (29 June 2011); http://www.afssaps.fr/var/afssaps-site/storage/original/ application/39acdab927235584ccfa340e4a9d3896.pdf
4. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) http://eurlex.europa.eu/LexUriServ/LexUriServ.do? uri=CONSLEG:1993L0042:20071011:EN:PDF
5. Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/EEC Relating to Medical Devices, MEDDEV 2.5-7 rev 1 (July 1998)
6. TÜV Rheinland® press release, Concerning latest media articles concerning Silicone-filled breast implants (29 December 2011) www.tuv.com/en/corporate/about-us-1/press/news-2/new s-5.jsp
7. Regulatory Framework Revision Roadmap http://ec.europa.eu/governance/ impact/planned-ia/docs/2008-sanco-081-proposal-medical-devices-en.pdf
8. European Commission Press Release, Medical devices: European Commission calls for immediate actions - tighten controls, increase surveillance, restore confidence (9 February 2012);http://europa.eu/rapid/pressReleasesAction.do? reference=IP/12/119&format=HTML&aged=0&language=EN&guiLanguage= en.