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Cereform breast implants and associated sizers - update - product cancellation
Updated information - product cancellation
The TGA has cancelled Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods (ARTG) at the request of the sponsor, Medical Vision Australia Plastic & Cosmetic Pty Ltd.
The cancellation took effect from 29 October 2014 and covers the following devices:
- Cereform Silicone Gel-Filled Breast Implant (Smooth Texture)
- Cereform Silicone Gel-Filled Breast Implant (Intermediate Texture)
- Cereform Optima Silicone Gel-Filled Breast Implant
- Sizer, mammary prosthesis.
The TGA had previously suspended Cereform silicone gel-filled breast implants and associated sizers from the ARTG from 23 May 2014. While this 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 has not become aware since the most recent update on 28 May 2014 of any increased infection rates among patients receiving Cereform breast implants either in Australia or overseas.
Medical Vision Australia Plastic & Cosmetic Pty Ltd voluntarily ceased supply of these devices on 13 February 2014.
Following on from a TGA 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.
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.
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.