Poly Implant Prothese (PIP) breast implants - TGA update, 2 March 2012

Reports of rupture of PIP breast implants

As an important part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns. As of 1 March 2012, the TGA had received:

• 163 confirmed reportsⁱ of rupture of PIP breast implants
• 19 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:

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

The sources of the unconfirmed reports have been:

• 16 unconfirmed reports from surgeonsⁱⁱ
• 3 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.

Update to testing results of PIP breast implants

On 12 January 2012 the TGA posted on this website the results of shell integrity testing (the capacity of the implant shell to remain intact) of eight samples of PIP breast implants from seven separate lots supplied in Australia. All eight samples passed the requirements of the relevant standard for shell integrity (ISO 14607:2007 Annex B Section 1.2).

Since then, the TGA has tested the shell integrity of another seven samples of PIP breast implants from six lots of PIP breast implants that were supplied in Australia and has updated previous results. Details of these test results are available at: Update to testing results of PIP breast implants.

In order to meet the standard for shell integrity, each sample must be able to be stretched to 450% of its original length before breaking. All 15 samples tested have met this requirement.

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 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.

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.

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.