PIP breast implant information

There continues to be a number of media reports, particularly in France and in the United Kingdom regarding French manufactured breast implants, produced by Poly Implant Prothese, or PIP, which have been the subject of regulatory concern.

Authorities in France have found that these silicone-gel implants are manufactured with a type of silicone gel that was not approved for use and may rupture. These implants have been used in Australia.

To date, UK authorities have uncovered no increased risk of toxicity. All breast implants have a risk of rupture (approximately 10 to13 per cent in ten years). However, the TGA in Australia has tested and found the strength of PIP implants meets relevant international standards for manufacture.

The College has been asked by the Therapeutic Goods Administration (TGA) to contribute to an expert advisory panel to provide further information and to assist in the assessment of the risk that PIP implants may pose to Australian women who have had them implanted.

Dr Daniel Fleming, a former College president and one of Australia’s most experienced breast augmentation surgeons, will participate on the expert panel on behalf of the College.

Following a meeting of the advisory panel on 4 January 2012, the TGA has issued advice for Australian patients and it can be viewed at these links:

• TGA Media Release - PIPS Breast Implants
• TGA Update On PIPS Implants - Poly Implant Prosthese (PIP) breast implants - the Australian perspective

The conclusion of this advice is that women with PIP implants in Australia have no cause for alarm and need not take any action at this time.

The College advises anyone who believes that they may have these implants that they should not be unduly alarmed. They should contact their doctor or surgeon for further advice if they still have concerns.

The College will continue to monitor inquires and provide additional information as developments require.