Poly Implant Prothese (PIP) breast implants - the Australian perspective - update, 20 January 2012
As of 20 January 2012, the TGA estimates that approximately 12,3001 silicone gel breast implants manufactured by PIP have been supplied or approved for supply to Australian surgeons between 1998 and 2010.
This does not mean that 12,300 individuals have received these implants as many patients may have received two implants, and some implants may not have been surgically implanted. Some patients may have subsequently had their implant removed.
As of 19 January 2012, the TGA had received:
- 57 confirmed reports of rupture of PIP breast implants
- 41 unconfirmed reports of rupture of PIP breast implants.
The TGA is continuing to investigate these unconfirmed reports. The TGA categorises reports as 'confirmed' if there is sufficient information to uniquely identify:
- the patient
- the implant used
- 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.
The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) from Australians who have received PIP implants. However, over the past two years, the TGA has received reports of six patients with ALCL who received other brands of breast implants (filled either with silicone gel or saline).
To date, the Australian (TGA), French (AFSSAPS) and UK (MHRA) authorities are the only regulatory authorities in the world that have conducted laboratory testing on batches of PIP breast implants. The international testing covered samples across a range of manufacturing dates and batches.
On 7 April 2010 the TGA tested eight samples of various profiles, sizes and dates of manufacture of PIP breast implants for their physico-mechanical properties (shell and gel) and cytotoxicity (shell and gel) in accordance with international standards. A report of findings is available on the TGA website.
The TGA is continuing to test implants, and scientific experts in the TGA are working with their international colleagues to examine the feasibility and scientific validity of testing PIP implants that have been removed from patients.
The TGA will continue to release information on its scientific testing as confirmed results becomes available.
French regulatory authorities have advised that the manufacturer used chemical analogues of the approved silicone gel in PIP breast implants.
Approved silicones have undergone chemical and biological testing processes that certify that the approved material meets required standards. The silicones that were apparently used in PIP implants were not approved in this way. This does not necessarily mean that they are unsafe, but rather that their safety has not been tested.
To date, testing conducted by the TGA, the MHRA and the AFSSAPS has found that the gels used in PIP implants are not toxic to cells (cytotoxic) and are not damaging to DNA (genotoxic). Further testing is underway.
The TGA has been working closely with regulatory counterparts throughout the world to analyse information as it becomes available. On 11 January 2012 the TGA hosted an international teleconference with countries from North and South America, Europe and Asia to discuss the evidence available on the safety of PIP breast implants and the merits of different scientific and regulatory approaches.
The TGA has convened a small group of scientific experts from the European Commission, Germany, Brazil, Ireland and the Netherlands that will work together to plan and execute further laboratory testing on PIP implants. This group last met on 19 January 2012.
The TGA is continuing to work with surgical experts, state and territory health departments and medical insurers, to obtain further comprehensive data on breast implant revision rates in Australia.
On 20 January 2012, the TGA reconvened an expert panel consisting of clinical, scientific and epidemiological experts to provide them with an update on regulatory investigations in Australia and overseas.
All Australian surgeons known to have been supplied with PIP breast implants have been individually contacted by the TGA. The TGA has asked the surgeons to contact patients implanted with PIP breast implants for medical follow-up.
The scientific investigation undertaken by the TGA will form one piece of a complex risk assessment being undertaken by health authorities in Australia and overseas. This evidence will inform public health decisions related to patients with PIP breast implants.
Patients and healthcare professionals are strongly encouraged to report problems with medical devices including breast implants to the TGA.
- This updated information is based on the identification of supply that may have occurred through the use of alternative supply mechanisms (Category B of the Special Access Scheme or as part of a clinical trial) in addition to usual authorised supply arrangements.