[Evolutive French regulation and materiovigilance specific to the breast implants].
Too much a long time the manufacture of the breast implants does not have the object of a specific regulation. This lack led partly to the prohibition of the implants filled with silicone in 1995. It took 10 years for the European Union to create and to set up a standard EC specific to the breast prosthesis. It's the history of these steps as well on the level of Europe as has the French scale as we report you. Initially classified as implantable devices of IIb level, the breast implants were reclassified on level III in 1993, the highest level of requirement of CE marking. In accordance with the recommendations of the group of experts named by the Afssaps, the technical standard IN ISO 14630:1997, fixing the mechanical properties of the prosthesis, is in the course of revaluation since 2004. According to Council Directive 93/42/EEC of the June 14th 1993, the French government instituted a materiovigilance specific to the breast implants. All these evolutions allow, now a serene use of the breast implants.
Gangloff
D
D
Service de chirurgie plastique et brûlés, CHU de Rangueil, Toulouse-I, avenue Jean-Poulhès, TSA 50032, 31059 Toulouse cedex 09, France.
Ghislain
J C
JC
Grolleau
J-L
JL
Chavoin
J P
JP
D018427:Breast Implants / Q000266:history* / Q000592:standards*; D005260:Female; D005602:France; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D012307:Risk Factors