The Danish Medicines Agency warns against the use of silicone gel filled breast implants marked IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse.
According to the French authorities, there are presently no identified complications, apart from those normally occurring from the use of any other breast implants. However, there is a higher risk that these implants may rupture.
During an inspection of the manufacturer, the French Medicines Agency (AFSSAPS) found that the silicone gel that has been used for manufacturing the implant since 2001 differs from the one specified in the technical documentation for the products’ CE marking. Thus, the products are not legally CE marked.
The products are primarily used for cosmetic surgery. The Danish Medicines Agency has warned Danish clinics performing cosmetic surgery against using these products.
The French authorities have prohibited any marketing of the products, and they are carrying out further investigations. From the information available, the French authorities have chosen to suspend all use of the concerned breast implants in France.
The Danish Medicines Agency recommends women with the breast implants in question to contact the doctor/clinic that performed the operation in order to get the implants examined.
For further information, please contact Ellen Jespersen on tel. +45 4488 9790.
Danish Medicines Agency, 8 April 2010
