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Poly Implant Prothese (PIP) breast implants - the Australian perspective

Related information

4 January 2012

At the time of writing, the TGA has been advised that approximately 9,054 PIP breast implants have been implanted by surgeons between 2002 and 2010. In April 2010 non-implanted PIP breast implants were recalled from the Australian marketplace.

The TGA advises that, based on current rates of reporting of implant rupture to the TGA, there is no evidence of an increased rupture rate for PIP silicone gel breast implants used in Australia.

The TGA has received 37 reports of rupture of PIP breast implants. This equates to a rate of 0.4% of PIP implants inserted in Australia over the past decade. This rate is well within the expected rupture rate for silicone breast implants.

Long term follow up studies conducted in the USA show that rupture rates for silicone breast implants are approximately 1.0% per year. That means that for breast implants of all types approximately 10% of implants will have ruptured by 10 years after insertion. Detailed information on the long term outcomes of breast implants can be found in the:

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TGA's response to safety concerns about PIP breast implants

PIP implants were recalled following concerns from the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of ruptures with PIP breast implants as a result of use by the manufacturer of non-approved silicone in the gel in the implants.

The TGA issued six safety advisories on its website regarding this matter:

The TGA also required the sponsor of PIP implants, Medical Vision Australia, to contact all implanting surgeons to advise them of the recall and the need to follow up their patients.

The TGA has tested PIP implants to determine the strength of the outer shell of the implant and its ability to resist rupture and determined that the PIP breast implants from the batches supplied and tested in Australia meet the relevant international standards for tensile strength. This differs from the results of testing of implants supplied in France by the French regulator AFSSAPS which showed lower tensile strength on one measure. This raises the possibility that the higher rates of rupture identified in France may relate to specific batches supplied in that country but not utilised in Australia.

Importantly, the TGA and its British counterpart, the MHRA, have analysed the gel used in the PIP implants to assess whether it is toxic to cells (cytotoxicity) or likely to affect the DNA of cells (genotoxicity). This testing has demonstrated that the silicone gel utilised in the PIP implants supplied in Australia and the UK is not cytotoxic nor likely to raise the risk of cancer (genotoxic).

The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) in Australian women who have received PIP implants.

PIP implants have not been available for use in Australia since April 2010 and no further patients undergoing breast implantation surgery will receive PIP implants.

Ongoing investigations

The manufacturer of PIP implants is currently the subject of a criminal investigation in France. This has limited the amount of information that is available to international regulators regarding the data that has led to actions in France.

The TGA has been working closely with international regulatory counterparts in the UK to analyse information as it becomes available. In addition, the TGA has sought information from a number of other countries including the USA, Canada, Japan, Switzerland and Singapore regarding rates of PIP implant rupture. To date there is no clear evidence of higher than expected rupture rates outside France.

It should be noted that in most countries, including Australia, estimates of breast implant rupture rates are based on reports of individual cases of implant rupture made to the regulator by patients, surgeons, or the company supplying the implant. This system of data collection is limited in that it does not gather information on all patients who have had a breast implant, rather it collects reports of problems in certain patients. More comprehensive information is provided through formal clinical trials such as those undertaken in the USA and through breast implant registries. The Australian Breast Implant registry is run by the Australian Society of Plastic Surgeons and patients may enrol and provide follow up information on their implant at Breast Implant Registry.

The TGA has convened an expert panel consisting of clinical, scientific and epidemiological experts from the TGA’s advisory committees on the safety of medicines and medical devices, and experts from the Royal Australian College of Surgeons, the Australian Society of Plastic Surgeons and the Australasian College of Cosmetic Surgeons.

The TGA is continuing to work with surgical experts, state and territory health departments and medical insurers, to obtain further comprehensive data on breast implant revision rates in Australia and will continue to issue advice on this over coming months as information becomes available.

Information for patients

Information of the type and model of breast implant you have received should be on the Consent to implant silicone gel-filled breast implant form completed at the time of implant.

A rupture of a breast implant is either intra capsular with the gel confined to within the fibrous capsule around the implant or extra capsular where the gel has extended into the breast or other localised tissues. Both are usually asymptomatic but localised inflammation causing lumps and/or discomfort may occur typically with extra capsular rupture.

Your implanting surgeon should discuss the risks of rupture and other potential complications of breast implant surgery with you prior to your operation as part of the obtaining of informed consent.

The Australian Society of Plastic Surgeons has posted information on their Internet site that encourages all women with breast implants to register their implant on the Breast Implant Registry and to review the information on the TGA Internet site.

Patients wanting more information on breast implants may wish to review the advice on the US FDA or MHRA websites.

The TGA strongly advises patients to continue to routinely check their silicone gel breast implants and to consult their implanting surgeon if they have any concerns about the performance of their implants.

Information for health professionals

In 2010 the TGA required the sponsor of PIP implants to contact implanting surgeons to advise them of the recall and the need to provide appropriate follow up.

Based on current data, surgeons are again advised to ensure appropriate follow up has been undertaken including clinical and radiological assessment where indicated.

Based on data available currently, surgical removal of the implants is not recommended for patients who have not experienced a rupture of the PIP implant.

Reporting an adverse event

Consumers and healthcare professionals are encouraged to report problems with medical devices including breast implants to the TGA's Incident Reporting and Investigation Scheme (IRIS). Anyone (patients, caregivers, health professionals, sponsors and manufacturers) can report a problem with a medical device.

Content last updated: Wednesday, 4 January 2012

Web page last updated: Friday, 2 August 2013

URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-120104.htm