The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Cereform silicone gel-filled breast implants manufactured by Cereplas.
The TGA was advised on 13 February 2014 that non-implanted Cereform silicone gel-filled breast implants have been recalled in France after the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), found the sterilisation process used in the manufacture of these devices had not been fully validated in accordance with the most recent international standard.
Information from the ANSM states that the French recall is being undertaken because of regulatory non-compliance. They have further stated that they have not identified a health risk associated with this issue.
In Australia, the TGA has suspended further supply of these implants until it has finalized its investigation and determined that the implants are safe for use. TGA has sought information from ANSM and from the French manufacturer so that a decision about further supply of these implants can be made.
For details, please refer to the following link:
http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140221.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 24 February 2014