Poly Implant Prothese (PIP) breast implants - TGA update, 10 February 2012

Reports of rupture of PIP breast implants

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.

As part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns. As of 9 February 2012, the TGA had received:

1. 134 confirmed reportsⁱ of rupture of PIP breast implants
2. 15 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:

• 83 confirmed reports from surgeons
• 27 confirmed reports from patients who received PIP breast implants
• 24 confirmed reports from the device supplier

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.

The TGA is continuing to investigate all of these reports.

TGA analysis of international reports

How to access a pdf document

On 1 February 2012 the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks released a report on the PIP implant issue called "The Safety of PIP Silicone Breast Implants (pdf,470kb)". The conclusions of this detailed and extensive report are consistent with the analysis undertaken and expert advice received to date by the TGA. The detailed information contained in this report, along with further information that is being obtained from other Australian and international regulators, clinicians, consumer organisations and scientists is undergoing ongoing consideration and analysis by the TGA.

TGA and international laboratory testing program

The TGA continues to host meetings of international regulators who are sharing information on testing of PIP implants. At the same time, the TGA is continuing to undertake testing of PIP 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.

Information for 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.

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.