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Poly Implant Prothese (PIP) breast implants - TGA update, 17 February 2012

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17 February 2012

As part of the Australian Government's ongoing management of issues related to the recall of PIP silicone gel breast implants, the TGA has determined that approximately 13,000 PIP silicone gel breast implants were supplied in Australia between 1998 and 2010.

This does not mean that there are 13,000 individuals in Australia with PIP implants. This is because:

  • many individuals would have received two implants
  • not all implants supplied to the Australian market have been surgically implanted
  • many individuals may have subsequently had their implants removed and/or replaced.

PIP silicone gel breast implants were imported under special access arrangements as well as those supplied since the product was included in the Australian Register of Therapeutic Goods.

Reports of rupture of PIP breast implants

As part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns. As of 16 February 2012, the TGA had received:

  • 155 confirmedi reports of rupture of PIP breast implants
  • 16 unconfirmed reports of rupture of PIP breast implants.

The sources of the confirmed reports have been:

  • 99 confirmed reports from surgeons
  • 32 confirmed reports from patients who received PIP breast implants
  • 24 confirmed reports from the device supplier

The TGA is continuing to investigate all of these reports.

TGA PIP breast implant testing program summary

The TGA has convened an international laboratory testing group to share information on testing of PIP breast implants. In collaboration with this group, the TGA is continuing to undertake testing of PIP breast implants, including some that have been surgically removed, and will progressively release information on the outcomes of its scientific testing as confirmed results become available.

To date, all test results on both new and surgically removed (explanted) PIP breast implants have met relevant international standards for such devices. TGA analysis of explanted breast prostheses is ongoing, but testing to date has not identified any particular features of these explanted devices that are likely to adversely impact on the health of the patient who has had these implants inserted or removed.

The analysis undertaken by the TGA to date has shown that a milky fluid found in some explants is primarily a mixture of silicone and water, and that the gel from the explanted prostheses still meets the international standard for cohesiveness that applies to such products.

An outline of the current testing program is provided below.

Outline of TGA testing for PIP breast implants

Test Investigation
Toxicology tests

Intra-dermal irritation

In accordance with ISO 10993-10: 2010, intra-dermal irritation studies are being conducted to assess the potential for PIP breast implants to produce irritation.

Cytotoxicity

Cytotoxicity tests measure whether there are chemicals present in the material that are toxic to cells.

In accordance with ISO 10993:2009 Part 5, tests are being carried out to increase the pool of results of laboratory tests that have been conducted on silicone gel filled breast implants manufactured by Poly-Implant Prothese (PIP).

Chemical tests

Identification of silicone gels

Reports from the French regulator, AFSSAPS, indicate that there may be multiple formulations of silicone gel filler in the PIP breast implants. Tests are being carried out to determine chemical differences in the silicone gels that may then help to identify the different formulated gels used in the PIP breast implants. There are at least two different unauthorised silicone gels (known as PIP1 and PIP2), plus the authorised silicone gel (Nusil) that have been identified as being present in different batches of PIP breast implants.

Chemicals of possible concern

Chemical tests are being carried out to determine whether there are any chemicals of concern present in the gels of the PIP breast implants.

Physico-mechanical tests

Physico-mechanical properties

The TGA is continuing to test the physico-mechanical properties of PIP breast implants to increase the pool of results of laboratory tests that have been conducted on silicone gel filled breast implants manufactured by Poly-Implant Prothese (PIP).

Testing on explanted PIP breast implants

TGA is investigating selected PIP breast implants that have been surgically removed (explanted) from patients.

This investigation includes visual inspection, with microscopy and photography, as well as mechanical and chemical tests when appropriate.

Information for consumers and patients

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'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.

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.

Patients phoning the Breast Implant Information Line to enquire about reporting a rupture are advised to contact their treating doctor because it 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.

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, 17 February 2012

Web page last updated: Saturday, 3 August 2013

URL: http://www.tga.gov.au/safety/alerts-device-breast-implants-pip-120217.htm