PIP breast implants - TGA update, 9 March 2012

What happens to your reports?

As an important part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns. After it receives a report, investigators in the TGA thoroughly review all the information in the report. In cases where the information reported requires further clarification, or the TGA analysis of the problem will be better supported by more evidence, TGA staff will contact the reporter to seek more information.

The information generated by the reports is being shared with clinical experts in Australia, to ensure that appropriate action is taken by TGA in relation to PIP breast implants.

Some individuals with PIP breast implants have been reporting a variety of symptoms. The most important thing you can do if you have PIP breast implants and are experiencing ill health is to consult a health care professional as soon as possible.

TGA regulates therapeutic goods and cannot give individual clinical advice. If you suspect your symptoms are associated with your implant you should also report this to the TGA, or ask your health care professional to report it for you.

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.

Reports of rupture of PIP breast implants

As of 9 March 2012, the TGA had received:

• 171 confirmed reportsⁱ of rupture of PIP breast implants
• 26 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:

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

The sources of the unconfirmed reports have been:

• 22 unconfirmed reports from surgeonsⁱⁱ
• 4 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
• reviewing all reports where symptoms have been reported in association with a PIP breast implant and seeking further information
• continuing its testing program and the chemical analysis of the silicone gel in PIP breast implants.

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.

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.