PIP breast implants - TGA update, 16 March 2012

Related information

16 March 2012

Overview

Australia's medical devices regulator, the Therapeutic Goods Administration (TGA) again encourages women who have had breast prostheses implanted since 1998 to contact their surgeon to find out the brand of their implant and to attend for a check-up if they know or suspect they have an implant made by the French company Poly Implant Prothese (PIP).

This reminder follows updated advice received by TGA that European regulators have been unable to ascertain whether or not PIP implants have ever contained the silicone gel authorised by regulators, and that the French manufacturer may have fraudulently used an unauthorised gel in all batches manufactured since 1999.

A search of TGA records indicates that PIP implants are known to be first used in Australia in September 1999, having been available in the European market since June 1999. These implants were withdrawn from the Australian market in April 2010. Approximately 13,200 PIP breast implants were supplied to the Australian market.

TGA understands and shares the concerns of women who have had these devices implanted, and is working hard to identify any health risks associated with these products, including conducting extensive testing both on unused samples of PIP implants and, where surgeons have expressed specific concerns about features of those implants, on PIP implants that have been surgically removed from Australian women.

As of 15 March 2012, TGA has confirmed 180 ruptures of these implants in Australian women, and a further 25 unconfirmed reports are still being investigated. TGA has also received reports of other symptoms experienced by women who have these implants.

The TGA has developed an extensive regime of testing PIP implants against the international standards that apply to these devices. TGA is sharing the results of these tests with other regulators around the world, as well as keeping Australian doctors and consumers informed by publishing these results on our website. Fortunately, so far, all the PIP implants TGA has tested have met the requirements of these standards. In particular, TGA has not identified any toxic or irritant chemicals in either the shell of the implant or in the unauthorised gel, and the tests conducted by TGA on the strength of the silicone shell and the consistency of the gel have also met all relevant standards.

TGA continues to work with Australian medical and scientific experts

On 13 March 2012, the TGA reconvened its expert panel consisting of clinical, scientific, toxicological and epidemiological experts to provide them with an update on regulatory investigations in Australia and overseas.

This included an update on the TGA's laboratory testing program including work on:

  • identifying whether any toxic or irritant chemicals may be present in these devices, including testing to quantify the presence of low molecular weight siloxanes (small silicone molecules)
  • physico-mechanical testing (testing of the strength and durability of the shell and firmness of the gel)
  • the investigation of PIP breast implants that have been surgically removed from patients where the surgeon is concerned about unusual features of the implant.

The expert panel was also provided with the TGA's assessment of the toxicity of low molecular weight siloxanes and its relevance to humans. The panel agreed with the assessment that the low molecular weight siloxanes identified in the silicone gels from PIP breast implants are unlikely to represent a risk to human health.

The expert panel endorsed the TGA's ongoing testing program and commended the organisation for its world-leading efforts in the assessment of the safety of PIP breast implants.

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TGA laboratory testing program - an update

The scientific investigation undertaken by the TGA is one piece of a complex risk assessment being undertaken by health authorities in Australia and overseas to determine the health risks associated with having PIP breast implants.

One of the concerns with PIP breast implants has been the use of an unauthorised silicone gel. The French regulatory authority, AFSSAPS, has reported that the authorised and unauthorised silicone gels have different ingredients which can result in differences in the physical and chemical properties of the gel. In particular, AFSSAPS noted that some batches of unauthorised gels contained higher amounts of small silicone molecules (called low molecular weight siloxanes) than the authorised gel.

The TGA is continuing to measure the amounts of these small molecules in different batches of PIP breast implants. The results of the tests carried out so far are summarised in the table below.

Type of siloxane
(small silicone molecules)
Quantity in parts per million
range median
D4 0-261 136
D5 0-710 434
D6 0-1005 474

These results are generally consistent with the results obtained by the French authorities. The results of the TGA testing have not shown any relationship between year of manufacture and the presence of these small silicone molecules. Results of further testing will be published when the information becomes available.

Reports of rupture of PIP breast implants

As of 15 March 2012, the TGA had received:

  • 180 confirmed reportsi of rupture of PIP breast implants
  • 25 unconfirmed reports of rupture of PIP breast implants.

The TGA has received these reports from surgeons, patients and the Australian supplier. The sources of the confirmed reports have been:

  • 113 confirmed reports from surgeons
  • 43 confirmed reports from patients who received PIP breast implants
  • 24 confirmed reports from the device supplier.

The sources of the unconfirmed reports have been:

  • 20 unconfirmed reports from surgeonsii
  • 5 unconfirmed reports from patients or individuals.

The TGA is continuing to investigate all of these reports. This investigation includes:

  • obtaining additional information to allow confirmation of currently unconfirmed reports
  • asking surgeons to complete a questionnaire to provide additional clinical information in relation to all reported ruptures
  • reviewing all reports where symptoms have been reported in association with a PIP breast implant and seeking further information

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Medicare rebates

The Medicare rebate for MRI services for patients with PIP breast implants has been extended to 12 March 2015.

Normal Medicare arrangements apply to provide benefits to patients in respect of the costs of clinically relevant medical services relating to the management of their PIP implants, including for any consultations with their GP or surgeon. These include the provision of Medicare benefits for:

1. Consultations - Women who have had breast implants are encouraged to consult with their medical practitioner regarding the need for clinical follow-up or radiological investigation. Normal Medicare arrangements are available for this consultation.

2. Investigations - If considered medically necessary, as from 12 March 2012, women with a PIP implant can access a Medicare rebate for a PIP MRI service to assess the state of the implant. This referral, from either a specialist, consultant physician or a GP must state that the patient is suspected of having a PIP branded implant and note on the referral if the patient has symptoms of a rupture. The MRI scan will be undertaken by a specialist radiologist at an accredited diagnostic imaging provider with a breast coil.

Medicare rebates are also available for investigation by ultrasound.

3. Management - including removal and replacement where the clinician (surgeon) believes there is a physical (eg rupture) and/or psychological (eg significant anxiety) consequences of the prostheses remaining in place.

MBS rebates contribute to the medical costs, including those of the surgeon, anaesthetist and any surgical assistants.

Under the usual Medicare benefits arrangements the cost of prostheses, or implants, are not covered. Patients with private health insurance should contact their insurer to ascertain if their policy would cover the cost of the implant.

Medicare also does not cover private hospital accommodation and hospital theatre costs which may be subsidised by private health insurance.

Patients may elect to be treated through the public hospital system. A patient's medical practitioner can refer them to the nearest appropriate public hospital. The specialist can then advise the best course of action for the patient which may include surgical treatment.

Information for consumers and patients

It is important that decisions made by patients and their treating doctors about the need for further surgery are fully informed by the best available evidence, and take each individual patient's circumstances fully into account.

Following consideration of the additional information provided, TGA considers that the currently available evidence continues to support its previous advice that routine removal (explantation) of PIP implants in the absence of any evidence of clinical problems such as rupture was not recommended.

TGA's expert panel continues to strongly advise that all individuals with PIP implants should be encouraged to undergo a full clinical assessment (including diagnostic imaging such as MRI where appropriate), and removal of the implants should be considered on an individual basis depending on an assessment of the risks to the individual patient.

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 and those who are unsure about the brand of their breast implants are strongly encouraged to consult their general practitioner or surgeon for individual clinical assessment and advice.

Breast Implant Information line

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.

The Australian Government has set up a free call Breast Implant Information Line on 1800 217 257. Anyone concerned about their breast implants can call this line for further information.

Callers to the Breast Implant Information Line (1800 217 257) who express concerns regarding their implant are generally advised to contact their implanting surgeon or general practitioner (GP).

Reporting problems with breast implants

Patients and healthcare professionals are strongly encouraged to report problems with medical devices including breast implants to the TGA.

In reporting adverse events associated with their PIP implants, contact with their treating doctor is important to ensure that the TGA receives all the information that is required to officially confirm reported ruptures (or other problems) with these devices and to conduct further enquiries where necessary.

References

  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.
  2. The TGA has contacted these surgeons for further information but as yet has not received sufficient information to confirm the report.

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