Implants manufactured by the Brazilian company Silimed (breast, testicular, buttocks, calves, pectoral and face implants) have just had the CE marking temporarily withdrawn, allowing them to be marketed in France.
This suspension has just been announced by the German body responsible for the certification of medical products (TUV) and by the National Medicines Safety Agency (ANSM). “It follows the verification of the manufacturing site which established the presence of particles on the surface of the breast implants” underline the health authorities.
The sale of these products in France is therefore suspended and all the implants have been placed in quarantine by the distributor, thus prohibiting their use in health establishments.
“The information available today does not make it possible to identify a specific risk for patients implanted with these prostheses” underlines the ANSM in a press release. The Agency will conduct investigations in collaboration with the European authorities and recommends that all people who have questions about their implant to turn to the plastic surgeon.
This preventive measure to suspend the sale of implants in the European Union comes five years after the case of breast prostheses from the Poly Implant Prothesis (PIP) factory broke out in France.
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