Poly Implant Prothese (PIP) breast implants - TGA update, 24 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.

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 23 February 2012, the TGA had received:

• 161 confirmed reportsⁱ of rupture of PIP breast implants
• 16 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:

• 104 confirmed reports from surgeons
• 33 confirmed reports from patients who received PIP breast implants
• 24 confirmed reports from the device supplier

The sources of the unconfirmed reports have been:

• 14 unconfirmed reports from surgeonsⁱⁱ
• 2 unconfirmed reports from patients or individuals.

The TGA is continuing to investigate all of these reports: this investigation includes contacting the surgeons who have made unconfirmed reports to seek more information.

TGA PIP breast implant testing preliminary results

To investigate whether PIP breast implants contain chemicals that can cause irritation, the TGA commissioned intra-dermal irritation tests conducted in laboratories both in Australia and France.

The first stage of the tests included the shell and gel from four batches of PIP silicone breast implants and the shell and gel from one batch of another brand of silicone breast implant. None of the batches tested was irritant.

Results of further tests being performed in France should be available towards mid-March 2012.

All of these tests are being carried out in accordance with the relevant international standard (ISO 10993-10:2010).

TGA continues to work with Australian medical experts

On 4 January 2012 the TGA established an expert panel to provide advice to the TGA, in the Australian context, about appropriate action that should be taken by TGA in relation to PIP breast implants.

The expert panel met for the third time on 23 February 2012, and was provided with an update on developments since its last meeting on 20 January 2012, including an update on the TGA's laboratory teshttps://tga.slicedtech.com.au/media-release/information-regarding-tests-have-been-conducted-silicone-gel-filled-breast-implants-manufactured-poly-implant-prothese-pipting program.

The expert panel endorsed the ongoing testing program being coordinated by the TGA.

In addition, the report on "The Safety of PIP Silicone Breast Implants (pdf,470kb)" by the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks was discussed, and it was noted that the conclusions of this report were consistent with those of the TGA's expert panel on the evidence available to date.

A report issued by the French regulator (AFSSAPS) which summarised the results of their laboratory testing (pdf,1.72Mb was also discussed and the expert panel agreed that detailed consideration of its contents would need to await the provision of a certified translation of the currently available French report. However, a preliminary assessment of the French version has not raised any concerns that are not being investigated by the TGA.

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.

Following consideration of the additional information provided, the expert panel did not change its previous position that routine removal (explantation) of PIP implants in the absence of any evidence of rupture was not recommended.

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.

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). For patients phoning the information line to enquire about reporting a rupture, 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.

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