PIP breast implants - an updated Australian perspective
PIP breast implants - a summary
PIP breast implants are medical devices manufactured by a French company, Poly Implant Prothèse (PIP), which are composed of a silicone outer shell filled with a silicone gel.
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 the manufacturer had used unapproved materials in making these devices which may affect their safety and performance.
Approximately 13,200 PIP breast implants had been supplied to the Australian market during this time. This does not mean that 13,200 individuals have these implants, because many people would have received two implants, not all implants supplied to the market would have been used, and many people would have had their implants removed for a range of reasons.
Updated advice from European regulators is that PIP breast implants manufactured as far back as 1999 may contain unauthorised silicone gel. This is consistent with the advice provided by the TGA to Australian women, that anyone who has had a breast implant since 1998 should check the brand of their implant and seek medical advice if it was manufactured by PIP or if they are unable to find out the brand that was used.
In light of international concerns about the safety and performance of these implants, the TGA has been conducting an extensive investigation into PIP breast implants, and a considerable amount of evidence has now been collected.
These investigations have not found any evidence to suggest 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.
Expert advice provided to the TGA has concluded that the currently available scientific evidence does not support a recommendation to routinely remove (explant) PIP implants from people who do not have any evidence of problems associated with their implants.
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.
Finding out whether your breast implant is a PIP implant
Australian patients receiving breast implants are usually given a card after their surgery which contains details including the brand of the implant. If you have a PIP implant, the card will say Poly Implant Prothèse.
If you can't locate your card, your surgeon can tell you. If you are having trouble contacting your surgeon, or you can't remember your surgeon's name, your GP may have relevant information.
Breast Implant Information Line
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 health concerns related to their implants are generally advised to contact their implanting surgeon or GP.
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 (for 12 months from Monday, 12 March 2012) 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 (eg 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 treated through the public hospital system. A patient's medical practitioner can refer them to the nearest appropriate public hospital. The specialist can then advise the best course of action for the patient which may include surgical treatment.
The risks associated with breast implants
The TGA regulates breast implants as class III (high risk) medical devices.
Currently, US Food and Drug Administration evidence shows that at least 10% of all types of silicone breast implant break or leak within 10 years of being implanted, that 20-40% of women having breast implants inserted for breast augmentation, and 40-70% of women having breast implants for breast reconstruction, require further surgery within the first 8-10 years to modify, remove or replace their implants. Detailed information on the long term outcomes of breast implants can be found in the US FDA report on safety of breast implants (pdf,1.45Mb)
Surgeons proposing to insert breast implants should always discuss the risks of rupture and other potential complications of breast implant surgery with patients prior to any operation.
Ruptures of breast implants can be either:
- intra capsular: the gel is confined within the fibrous capsule around the implant
- extra capsular: the gel has extended into the breast or other localised tissues.
Localised inflammation causing lumps and/or discomfort is more likely to occur with extra capsular rupture. The risks of surgical removal (explantation) or replacement of an implant need to be balanced against the benefits for the particular individual in deciding whether to proceed with further surgery.
TGA laboratory testing and risk assessment
Since the French authorities determined that PIP breast implants were not manufactured according to the approved specifications, the TGA has been conducting an extensive testing program on these devices in order to identify whether there are any safety concerns associated with their use. This has involved testing samples from a range of batches, including samples of surgically removed (explanted) PIP breast implants. This testing does not involve the examination of every single explanted PIP breast implant, with individual feedback to individual patients. The purpose of the testing program is to help determine the safety of these devices by examining them in accordance with internationally recognised standards. Due to uncertainty about the consistency of manufacturing of PIP implants, surgeons have been asked to send the TGA any such devices that exhibit unusual or concerning features when they are removed.
To date, the results of the tests conducted by TGA on both new and surgically removed (explanted) PIP breast implants have met all the international standards that apply to other breast implants and which the manufacturer of PIP breast implants should have conducted to seek proper approval of these devices in the first place.
Laboratory testing progress
In April 2010, the TGA tested the shell and the gel from samples of PIP breast implants with various profiles, sizes and dates of manufacture, for their physico-mechanical properties and cytotoxicity in accordance with international standards. In March 2012, the TGA increased the number of samples of PIP breast implants tested for shell integrity by measuring the tensile elongation of further samples in addition to those samples that were tested in 2010. All tensile elongation results for the samples tested have met the requirements of the appropriate international standard.
A summary of TGA testing results
No concerns unique to PIP breast implants have been identified. The unauthorised gels from tested PIP implants are not cytotoxic (they do not contains chemicals that are toxic to living cells) and are not genotoxic (they do not affect the DNA of cells and so there is no extra risk of cancer from these implants).
To investigate whether PIP breast implants contain chemicals in either the shell or the gel of the implant that can cause irritation, the TGA has commissioned tests from laboratories both in Australia and France. None of the batches tested have shown that they are irritant.
The French regulatory authority, AFSSAPS, has reported that the authorised and unauthorised silicone gels have different ingredients which can result in differences in the physical and chemical properties of the gel. In particular, AFSSAPS noted that some batches of unauthorised gels contained higher amounts of small silicone molecules (called low molecular weight siloxanes) than the authorised gel. The results of the TGA testing for these small silicone molecules confirms the results obtained by the French authorities, but the presence of these chemicals (which are widely used in cosmetics) is not considered a health risk.
The analysis undertaken by the TGA to date has shown that a milky fluid found with some PIP implants when they are surgically removed is primarily a mixture of silicone and water, and that the gel from the removed implants still meets the international standard for cohesiveness that applies to such products.
TGA is working with Australian and international medical and scientific experts
An expert advisory panel was convened to review the evidence related to the safety of PIP breast implants on 4 January 2012. This panel comprised clinical, scientific and epidemiological experts from TGA statutory medicine and medical device safety committees, along with additional surgical experts from the Royal Australasian College of Surgeons, the Australian Society of Plastic Surgeons and the Australasian College of Cosmetic Surgeons.
On 4 January 2012, the experts concluded that there was no evidence of an increased rupture rate for PIP implants in Australia, and that there was insufficient evidence of a problem with the Australian supplied implants to warrant routine removal of implants that have not ruptured.
On 1 February 2012, the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks released a report on the PIP implant issue called "The Safety of PIP Silicone Breast Implants (pdf,470kb)". The conclusion of this detailed and extensive report was that there is no evidence to support a recommendation that women with PIP implants who do not have any problems with their implants should have surgery to remove or replace them. This conclusion is consistent with the analysis undertaken, and expert advice received to date, by the TGA.
The TGA's expert panel last met on 13 March 2012, to consider an update on evidence available from investigations both in Australia and overseas. The expert panel commended TGA for its world-leading efforts in the assessment of the safety of PIP breast implants and endorsed the TGA's ongoing testing program. The expert panel agreed that there was still no evidence to suggest that women with PIP implants that are not causing clinical concern (such as rupture or other symptoms) should have them surgically removed.
The TGA has convened an international laboratory testing group to share information on the results of tests on PIP breast implants, and to consult on further tests that may be helpful. In collaboration with this group, the TGA is continuing to undertake testing of PIP breast 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.
TGA's regulatory role
Pre-market regulatory activities
Before a medical device is allowed on the market, the manufacturer must carry out an assessment of how their device conforms to regulatory standards. For devices of medium and high risk, an independent organisation must verify that it meets the relevant legal requirements. Breast implants are considered high risk devices and are submitted to stringent pre-market review. In particular, the design dossier regarding the device is examined in detail and the manufacturer's quality system is audited to ensure that all devices produced by that manufacturer conform to the approved design or type.
Before including breast implants manufactured by the French company, Poly Implant Prothèse (PIP), on the Australian Register of Therapeutic Goods, the TGA inspected the manufacturing facility in France. During this inspection a number of deficiencies were identified, and were subsequently satisfactorily addressed by the company. Ongoing Australian marketing approval required continued oversight by an independent European assessment organisation called a 'notified body'.
Post-market regulatory activities
The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer continues to operate according to the approved quality system. At the time of a visit, the notified body may, where necessary, carry out tests or ask for tests to be carried out in order to check that the quality system is working properly. The notified body for PIP, TUV Rheinland, continued to provide oversight of the manufacturing of PIP breast implants on behalf of European regulators and the TGA after these devices were registered for use in Australia.
PIP implants were recalled in Australia in April 2010 following concerns from the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of ruptures with PIP breast implants as a result of use by the manufacturer of non-approved silicone in the gel in the implants. As part of the recall, the TGA required the Australian sponsor of PIP implants, Medical Vision Australia, to contact all implanting surgeons to advise them of the recall and the need to follow up their patients.
However, the TGA cannot recall devices that have been implanted. The TGA's legal authority in relation to recalls of implantable devices does not extend to devices that have already been surgically implanted in patients - the TGA can neither direct a doctor to remove a device, nor direct a patient to have the device removed. The TGA does, however, ensure that medical practitioners who have implanted such devices are made aware of the recall where this may be relevant to ongoing clinical management.
Decisions about the subsequent clinical management of implanted devices that have been subject to a recall, such as the PIP breast implants, become an issue for consultation between a patient and their treating doctor, in which that patient's individual circumstances and preferences can be appropriately taken into account.
The TGA also issues media releases and publishes information on its website to help patients who have these devices implanted to have informed conversations with their treating health professionals.
The TGA has issued six safety advisories on its website regarding PIP breast implants:
Since January 2012, the TGA has continued to regularly publish updated information on PIP breast implants as it has become available. After the French authorities expressed further concerns about these products in December 2011, the TGA began contacting all individual surgeons known to have used PIP implants to advise them of the situation, and to advise that they contact their patients for clinical review. A letter was sent to these surgeons formalising this advice on 9 January 2012.
Reports of problems with PIP breast implants
In most countries, including Australia, information about adverse events associated with medical devices is based on spontaneous reports of individual cases made to the regulator by patients, surgeons, or the company supplying the implant. This system of data collection is limited in that it does not gather information on all patients who have used a medical device. In certain circumstances, the TGA stimulates the reporting of adverse events, for example by liaising with peak stakeholder organisations, directly contacting individual medical practitioners, by placing notices on its website, or by issuing media releases.
More comprehensive information can also be obtained through formal clinical trials, such as those undertaken in the USA, and by accessing data from clinical registers. The Australian Breast Implant Registry is run by the Australian Society of Plastic Surgeons and patients may enrol and provide follow up information on their implant.
All surgeons who have reported a rupture of a PIP implant have been sent a questionnaire seeking further clinical details.
The table below shows the number of instances of ruptured PIP breast implants notified to the TGA as of 23 March 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.
The TGA has also received reports of other problems associated with the use of PIP breast implants, but has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) in Australian women who have received PIP implants.
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 PIP 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.