Poly Implant Prothese (PIP) breast implants - TGA update, 27 January 2012

As part of its regulatory activities, the TGA encourages reports of problems with medical devices to help identify and respond to safety concerns. The publicity surrounding the problems with PIP breast implants, including direct contact by the TGA with every surgeon known to have used these implants, has resulted in a continual increase of the number of ruptures reported to the TGA.

As of 26 January 2012, the TGA had received:

1. 102 confirmed reportsⁱ of rupture of PIP breast implants
2. 14 unconfirmed reports of rupture of PIP breast implants.

The TGA is continuing to investigate these reports.

TGA laboratory testing program

The TGA has convened an international laboratory testing group to share information on testing of PIP implants. In collaboration with this group, 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 also 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.

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.