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PIP breast implants - TGA update, 25 May 2012
PIP breast implants - background
PIP breast implants are medical devices manufactured by a French company, Poly Implant Prothèse (PIP).
PIP breast implants are known to have been used in Australia from September 1999 until April 2010, when non-implanted PIP breast implants were recalled from the market following advice from the French regulator (AFSSAPS) that in making these devices the manufacturer had used unapproved materials which may affect their safety and performance.
The Chief Medical Officer, Professor Chris Baggoley, has published a report and fact sheet about PIP breast implants. This information is available at:
- Poly Implant Prothèse (PIP) Breast Implants: Report of the Chief Medical Officer
- Fact Sheet - Silicone gel filled Breast Implants.
Testing undertaken by TGA to date has not found evidence that the risks involved with the use of PIP breast implants are any greater than those for any other brand of silicone gel-filled breast implants.
TGA continues to work with Australian medical and scientific experts
On 17 May 2012, the TGA reconvened its expert panel consisting of clinical, scientific, toxicological and epidemiological experts. The expert panel was advised that the TGA is continuing to perform tests to check for the presence of any substances or contaminants in PIP implants that may be toxic. The results of testing conducted and commissioned by the TGA and other regulators indicate that the implants contain no chemicals other than those known to exist in silicones, and in particular no chemicals that are likely to affect the health of women with these implants. Results of testing also show that mechanical, physical and chemical properties of PIP implants are typical of breast implants in general.
The expert panel recommended that further biological safety testing should only be considered in light of the detection of any chemicals of concern.
The expert panel reiterated its previous advice that routine explantation of PIP implants in the absence of rupture is not justified by currently available evidence, but that women with PIP implants should be strongly encouraged to undergo a full clinical assessment, including MRI.
The expert panel noted that data obtained from the Government subsidised MRIs may be useful to help ascertain the rupture rate of PIP implants. The expert panel noted the importance of clinician engagement in any epidemiological studies designed to investigate rupture rates further and encouraged implanting surgeons to actively participate in any such study.
Information for consumers
The Australian Government's advice remains that removal of PIP breast implants in the absence of evidence of rupture is not routinely required.
It is important that decisions made by patients and their treating doctors about the need for further surgery are fully informed by the best available evidence, and take each individual patient's circumstances fully into account.
People with PIP implants, and those who are unsure about the brand of their breast implants, are strongly encouraged to consult their general practitioner (GP) or surgeon for individual clinical assessment and advice.
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.
Information for consumers and patients with breast implants, including a series of videos, is available from HealthDirect.
The Medicare rebate for MRI services for patients with PIP breast implants has been extended to 12 March 2015.
Normal Medicare arrangements apply to reimbursing patients for the usual cost of medical services related to dealing with health concerns about their PIP implants, including ultrasound examinations and any consultations with their GP or surgeon.
Women who know that they have PIP breast implants, or where clinical advice is that they might have PIP implants, are now able to access Medicare rebates for MRI services examinations to accurately assess the state of their implants.
Medicare rebates are also available for the removal and replacement of breast implants where the treating clinician (surgeon) believes there are physical (e.g. rupture) and/or psychological (e.g. significant anxiety) indications for such surgery. Medicare rebates contribute to the fees charged by doctors, including those of the surgeon, anaesthetist and any surgical assistants, but Medicare rebates do not cover the cost of replacement breast implants. Patients with private health insurance should contact their insurer to ascertain if their policy would cover the cost of the implant.
Medicare also does not cover private hospital accommodation and hospital theatre costs, which may also be subsidised by private health insurance.
Patients may elect to be referred by their medical practitioner to the nearest appropriate public hospital. The hospital specialist can then advise the patient about the best course of action which may include surgical treatment.
Reports of problems with PIP breast implants
Approximately 13,000 PIP silicone gel breast implants were supplied in Australia between 1998 and 2010. The table below shows the number of instances of ruptured PIP breast implants notified to the TGA as of 24 May 2012.
|Reporter||Confirmedi ruptures||Unconfirmedii ruptures|
- The TGA categorises ruptures 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 sought further information but as yet has not received sufficient information to uniquely identify the rupture.
Reporting problems with breast implants
Patients and healthcare professionals are strongly encouraged to report problems with medical devices including breast implants to the TGA.
In reporting adverse events associated with your breast implants, contact with your 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 and to conduct further enquiries where necessary.