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Poly Implant Prothese (PIP) breast implants - TGA update, 3 February 2012

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3 February 2012

PIP breast implants were available in Australia between 1998 and April 2010. In April 2010 non-implanted PIP breast implants were recalled from the Australian marketplace following reports of increased risk of rupture with PIP breast implants as a result of use by the manufacturer of non-approved silicone gel.

TGA regulatory activities - pre-market

Before including breast implants manufactured by the French company, Poly Implant Prothèse (PIP), on the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration (TGA) inspected the manufacturing facility in France. During this inspection a number of deficiencies were identified, satisfactorily addressed by the company, and ongoing Australian marketing approval required continued oversight by a European 'notified body'.

Before marketing a medical device, the manufacturer of that device must carry out an assessment of how their device conforms to regulatory standards. For devices of medium and high risk, an independent conformity assessment organisation, called a 'notified body', must verify that it meets the relevant legal requirements. Breast implants are considered a high risk device and are submitted to stringent pre-market review. In particular, the 'notified body' is required to examine either the design dossier regarding the device and audit the manufacturer's quality system to ensure that all devices produced by that manufacturer conform to the approved design or type.

The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system. The notified body may also make unannounced visits to the manufacturer. At the time of a visit, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. This notified body, TUV Rheinland, continued to provide oversight of the manufacturing of PIP breast implants on behalf of European regulators and the TGA.

TGA regulatory activities - post-market

In April 2010, acting on updated advice from French regulatory authorities, the TGA took prompt regulatory action to ensure that unimplanted PIP breast implants were withdrawn from the Australian market. On 6 April 2010, as part of the recall information, the TGA published advice on its website that patients with PIP silicone gel implants who have concerns should contact their treating breast implant physician for advice and follow-up.

The TGA advised the Australasian College of Cosmetic Surgery (ACCS) and the Australian Society of Plastic Surgeons (ASPS) of the recall so they could pass on this information to their members. The TGA also requested the Australian sponsor of PIP breast implants to contact surgeons directly who purchased PIP breast implants, informing them of the market recall and reminding surgeons of the need for follow-up of patients implanted with this product. The TGA also advised the ASPS and ACCS of updates to its website information in October 2010 and held a teleconference with representatives from these groups in February 2011.

Since that time, TGA has continued to conduct scientific tests on available samples of PIP implants, including some that have been surgically removed, and has recently commissioned intra-dermal irritation tests on PIP breast implants. This testing will take several weeks to complete.

The TGA continues to consult with Australian and international experts (including with scientific, clinical and consumer representatives), to monitor the emerging Australian and international evidence, and to maintain regular and ongoing communication with international regulators including the US FDA and European authorities.

Reports to the TGA of adverse events with PIP breast implants

As of 20 January 2012, the TGA estimates that approximately 12,3001 silicone gel breast implants manufactured by PIP have been supplied or approved for supply to Australian surgeons between 1998 and 2010.

This does not mean that 12,300 individuals have received these implants as many patients may have received two implants, and some implants may not have been surgically implanted. Some patients may have subsequently had their implant removed.

As of 2 February 2012, the TGA had received:

  • 123 confirmed reports of rupture of PIP breast implants
  • 14 unconfirmed reports of rupture of PIP breast implants.

The TGA is continuing to investigate these unconfirmed reports. The TGA categorises reports as 'confirmed' if there is sufficient information to uniquely identify:

  • the patient
  • the implant used
  • that an X-Ray or other diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed.

The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) from Australians who have received PIP implants. However, over the past two years, the TGA has received reports of six patients with ALCL who received other brands of breast implants (filled either with silicone gel or saline). There is no evidence that breast implants, including PIP implants, are associated with a higher risk of breast cancer.

TGA work with medical experts

In response to advice from the French Government in December 2011 that women with PIP implants should have them removed in light of unlawful practices by the manufacturer of PIP implants, TGA called together a panel of expert physicians to assess the current situation.

The medical experts' group, which was convened on 4 January 2012, comprises clinical, scientific and epidemiological experts from the TGA's statutory medicine and medical device safety committees along with additional surgical experts from the Royal Australasian College of Surgeons, the Australian Society of Plastic Surgeons and the Australasian College of Cosmetic Surgeons to review the PIP issue. The experts concluded that there was currently no evidence of an increased rupture rate for PIP implants in Australia, and at this stage there was insufficient evidence of a problem with the Australian supplied implants to warrant routine removal of the implants that have not ruptured. On 7 January 2012 the TGA began contacting individual surgeons known to have used PIP implants to advise them of the situation, and to seek additional information. A letter was sent to these surgeons formalising this advice on 9 January 2012. In February 2012, the European Commission (EC) released a scientific report with advice that was entirely consistent with the view of Australian experts.

The TGA and Australian health authorities take this issue very seriously and are working with clinical and scientific experts from around the country, and with international counterparts to obtain more comprehensive information that will help further inform the risk assessment of this situation. It is expected that further advice will be issued to patients when more information has been obtained and assessed.

TGA communications with the public

The Australian Government set up a free call Breast Implant Information Line on 7 January 2012. This information line is now closed. If you would like to talk to a health professional please call Health Direct Australia on 1800 022 222.

On behalf of Australian individuals with these implants, the TGA has been very proactive, and has regularly updated its public advice as new evidence emerged. As further evidence has emerged, the TGA has consistently advised that individuals who have had PIP breast implants, or who are not sure of the brand of their implant, should contact their surgeon to discuss appropriate follow-up.

In addition, the Australian Government established a 24 hour information hotline for women to receive advice and to leave their details which will assist in determining how many women have had PIP implants and to gain information directly from women about their implants: Breast Implant Information Line - 1800 217 257. As at 2 February 2012 there had been 2072 callers to the hotline. Callers seemed to appreciate the opportunity to speak to someone and receive appropriate advice.

All breast implants carry the risk of rupture. As a result of ongoing communication from Australian health authorities to both surgeons and the general public, the number of patients with breast implants who have reported ruptures is expected to increase.

This is one of the intentions of encouraging women with implants to seek advice from their surgeons.

Information for patients

The Australian Government's advice remains that removal of PIP breast implants in the absence of evidence of rupture is not routinely required. Patients with PIP implants or who are unsure about the brand of their breast implants should consult their general practitioner or surgeon for individual clinical assessment and advice.


Reference

  1. The TGA categorises reports as 'confirmed' if there is sufficient information to uniquely identify:
    1. the patient
    2. the implant used
    3. that an X-Ray or other diagnostic image showed that the device was ruptured; or the implant was found to be ruptured when it was removed.

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Content last updated: Friday, 3 February 2012

Web page last updated: Monday, 29 July 2013

URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-120203.htm