In late December 2011, the French Government recommended that women with breast implants manufactured by the French company Poly Implant Prothèse should consider having them removed as a non-emergency precautionary measure. This was on advice from the French regulator, AFSSAPS, which was concerned about a possible increased risk of rupture and leaks of gel with these implants, and an irritant effect found at laboratory testing not seen with silicone gels from other prostheses. Overseas governments have responded to this issue in different ways: some, such as the UK, advising that there is not enough evidence to recommend routine removal(1) and encouraging women and clinicians to discuss the relative risks and benefits; with others, including the German, Dutch and Czech Republic governments, recommending that the implants be removed. It is noteworthy, however, that the European Commission, through the report of its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), has adopted a cautious approach and has not recommended routine explantation. They concluded that PIP implants may need to be exchanged for most women with a timeframe of the next 10-15 years(2).
3.1. Silicone gel filled Breast ImplantsBreast implants are used to augment breast size, or to reconstruct the breast following mastectomy or to correct an abnormality. In Australia, breast implants are either saline or silicone gel filled. A silicone gel filled breast implant is a silicone elastomer shell (sac) that has been filled with cohesive silicone gel.
3.2. PIP breast implantsNon-implanted PIP implants were recalled in Australia in April 2010 after the French regulatory authority (AFSSAPS) expressed concerns that there may have been an increased incidence of ruptures of this product associated with the use of an unauthorised silicone gel. The results of tests on gel cytotoxicity and shell strength conducted in 2010 on samples of PIP breast implants by the TGA, Australia’s regulatory authority for therapeutic goods, were all in accordance with international standards(3).
3.3. AustraliaFollowing the expression of further concerns in relation to PIP breast implants by the French government in December 2011, including a recommendation to women to have them removed as a non-urgent precautionary measure, the TGA initiated an expanded laboratory testing program to further assess the quality and safety of the PIP breast implants. The testing plan and results are presented in section 4: Testing PIP Breast Implants.
An Expert Panel was convened by the TGA (4 January 2012) to provide specialist input into the review of evidence and further investigation of the safety of PIP implants. This panel is composed of clinical, scientific and epidemiological experts from TGA statutory medicine and medical device advisory committees, and experts from the Royal Australasian College of Surgeons, the Australian Society of Plastic Surgeons and the Australasian College of Cosmetic Surgery.
A Clinical Advisory Committee was convened by the Chief Medical Officer (9 January 2012) to provide him with regular and frequent advice on clinical measures, risks and benefits, and communication strategies in response to health concerns related to PIP breast implants. The committee includes senior representatives of relevant clinical and consumer groups (see Appendix A for membership). The issues considered by this committee have greatly informed this CMO Report, focusing on the clinical issues and impact.
The aim of this report is to provide a source of information on the relevant scientific literature, testing results and clinical management support available on PIP silicone gel filled breast implants. It presents the current situation in Australia as at April 2012.
3.4. Breast implants in AustraliaThe TGA estimates that approximately 13,000 silicone gel breast implants manufactured by PIP have been supplied to the Australian market between 1999 and 2010. It is not known how many of these are currently implanted in women, nor how many women currently have this brand of implant, but an estimate of 5,000 women would appear reasonable as most women will have these for cosmetic breast augmentation reasons and have bilateral implants.
It is not known how many women, if any, received PIP breast implants from breast surgery performed overseas.
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