The TGA has suspended the Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods.
The suspension takes effect on 23 May 2014 and is for a period of 6 months unless earlier revoked by the TGA.
This action will ensure that, until the TGA is satisfied that the manufacturing process for Cereform silicone gel-filled breast implants and associated sizers complies with all regulatory requirements in relation to the validation of the sterilisation method, these devices cannot be supplied to the Australian market.
While the action was taken because the manufacturer had not fully validated the sterilisation process as required by regulations, this does not mean that Cereform implants were not sterile at the time of manufacture or supply.
If improperly sterilised implants had been supplied this would have been manifested in an increased rate of infection among patients receiving Cereform implants.
The TGA is not aware of any increased infection rates among patients receiving Cereform breast implants either in Australia or overseas.
The Australian distributor, Medical Vision Australia Plastic & Cosmetic Pty Ltd, voluntarily ceased supply of these devices on 13 February 2014.
Following on from a safety advisory on 21 February 2014 regarding Cereform gel-filled breast implants, Medical Vision Australia Plastic & Cosmetic undertook a recall of the implants and associated sizers.
A similar recall was undertaken in France after the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), found that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards.
As noted in the TGA's previous safety advisory for Cereform gel-filled breast implants, information from the ANSM stated that the French recall was undertaken because of regulatory non-compliance and that it had not identified a health risk associated with this issue.
As detailed in the TGA safety advisory for Cereform gel-filled breast implants, Medical Vision Australia Plastic & Cosmetic had already taken steps before the recall was undertaken to ensure Cereform breast implants were not implanted until the issue was resolved.
Medical Vision Australia Plastic & Cosmetic has undertaken these actions in consultation with the TGA.
Information for consumers
If you have received a Cereform breast implant and did not experience an infection soon after the surgery, then you should not experience any problems associated with this issue. An infection would be recognised by localised pain at the site of the implant and possibly an increase in body temperature.
If you have any questions or concerns about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.
Information for health professionals
If you have a patient who has received a Cereform breast implant, be alert to the issue and the potential complications for patients. Reassure them that if they were going to experience an infection related to this issue, it would occur in the immediate post-operative period.
Medical Vision Australia Plastic & Cosmetic has written to all health professionals and facilities using Cereform breast implants and sizers. If you are responsible for these devices but have not yet been contacted by Medical Vision Australia Plastic & Cosmetic, call 1300 661 559.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.