PIP breast implants: Consumer questions & answers

You may have seen some reporting in the media about a French brand of breast implant which may contain a silicone gel that is different to the gel approved by regulatory authorities.

The stories are about the PIP (Poly Implant Prothèse) brand of Breast Implant. This issue only affects women with this PIP brand of implant.

This brand was implanted in about 5000 women in Australia between 2000 and April 2010. A small number of PIP implants may have been used in 1998 and 1999.

If you had your breast implant before 1998 or after April 2010 in Australia, you are not affected. If you had a saline implant, you are not affected.

PIP breast implants are implants pre-filled with silicone based gel manufactured by the French company, Poly Implant Prothèse (PIP).

PIP breast implants were available in Australia between 1998 and April 2010 when they were recalled.

The implants were recalled following concerns by the French medical device regulatory authority (AFSSAPS) that there may be an increased incidence of ruptures and concerns that they contained unapproved ingredients.

Based on current numbers of implant ruptures reported to the Therapeutic Goods Administration, there is no evidence that more PIP silicone gel breast implants used in Australia have ruptured than would be expected from published studies on other brands of breast implant.

There are two types of ways that breast implants can rupture, break or leak with both usually having no symptoms (known as asymptomatic). A rupture of a breast implant is either:

• intra capsular with the gel confined to within the fibrous capsule that the body naturally forms around the implant or
• extra capsular where the gel has extended into the breast or other localised tissues.

Localised inflammation causing lumps and/or discomfort may occur typically with extra capsular rupture. Implanting surgeons should discuss the risks of rupture and other potential complications of breast implant surgery with patients prior to any operation.

There is no evidence that the PIP implant has a higher rate of breaking or leaking. Currently the US Food and Drug Administration evidence shows that about 10% of all types of silicone implants break or leak within 10 years of being implanted.

There is currently no evidence that the gel in the PIP implants causes cancer, and testing of the gel in the implants in Britain and France has confirmed this.

There is no need for routine removal of PIP breast implants.

There is no evidence that breast implants, including PIP implants, are associated with a higher risk of breast cancer.

The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) from Australians who have received PIP implants. However, the TGA has received reports of six patients who have been diagnosed with ALCL all of whom received other brands of breast implants (filled either with silicone gel or saline).

No toxic chemicals have been found in PIP breast implants (whether intact or ruptured) that are likely to affect the production of breast milk (lactation) in a woman with either ruptured or intact breast implants, or have any effect on the health of breast-fed babies.

No toxic chemicals have been identified in PIP breast implants that are likely to have any effect on a growing fetus or on the outcomes of a pregnancy.

Australian implant patients are usually given a card after their surgery which will have the details including the brand of the implant. If you have a PIP implant, the card will say Poly Implant Prothese.

If you can't locate your card, your surgeon can tell you.

If you are having trouble contacting your surgeon, your GP may have this information.

Saline implants are not part of this issue.

Go to your GP to see if they have it on file, or seek a referral to a surgeon.

Check any paperwork you have from your surgery to see if you can find advice about the brand of implant you have. If you have no information, go to your GP and seek advice.

Current advice from the Therapeutic Goods Administration and clinical experts is that there is no evidence that more PIP silicone gel breast implants used in Australia have ruptured than would be expected from published studies on other brands of breast implant.

However as a precautionary measure we recommend you make an appointment to have a clinical evaluation with your surgeon.

The Australian Government's advice remains that removal of PIP breast implants in the absence of evidence of rupture is not routinely required because the results of scientific testing to date have not shown that the risks of these implants outweigh the risk of surgery. However, 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.

Australia has taken a very considered and comprehensive approach to considering the available evidence associated with PIP implants and has undertaken a range of tests and gathered expert evidence to support responsible Government decision making.

Although a few countries have taken a different approach, the advice given by the Australian Government is similar to many other countries including the European Commission and is based on careful assessment of the currently available best evidence.

Surgery to remove implants is associated with risk and at the current time, the risk of this surgery where there is no evidence of rupture appears to outweigh any benefit, although decisions for individual patients are best made after consultation with their doctors.

The usual Medicare arrangements will apply. There may be some "gap" payments.

As doctors determine their own fees, the cost of surgery may vary considerably.

Medicare will pay a rebate for surgery to remove and replace breast implants when it is medically necessary to do so. The Medicare subsidy for the most common procedure to remove and replace both implants is $750.

In addition, the anaesthetist will charge fees for which there are Medicare rebates. Medicare also provide rebates for diagnostic tests such as MRI and consultation with GPs and surgeons before the surgery.

Medicare does not cover the cost of replacement prostheses or the cost of hospital accommodation. Private health insurance should subsidise these costs for those with insurance.

As medical fees can vary considerably we recommend that you obtain specific information from your surgeon about the costs of surgery. Doctors are obliged to provide informed financial consent and if you are unhappy with the fees we recommend that you discuss your concerns with your doctor or obtain a second opinion.

You should discuss your circumstances and the risks associated with implants and surgery with your surgeon during the surgical consent process.

You may not know as leaking or rupturing can occur without a woman experiencing symptoms. The best way is to see your surgeon and have scans as necessary.

We will retain them so we can contact you at a later date if further information comes to light.

Before including breast implants manufactured by a French company, Poly Implant Prothese (PIP), on the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration (TGA) inspected the manufacturing facility in France. A number of deficiencies were identified, satisfactorily addressed by the company, and ongoing Australian marketing approval required continued oversight by a European 'notified body'. This notified body, TUV Rheinland, continued to provide oversight of manufacturing on behalf of European regulators and the TGA.

In April 2010, acting on updated advice from French regulatory authorities, the TGA took prompt regulatory action to ensure that PIP breast implants were withdrawn from the Australian market. On 6 April 2010, the TGA published advice on its website that consumers with these PIP silicone gel implants who have concerns should contact their treating breast implant physician for advice and follow-up.

Since that time, TGA has continued to conduct scientific tests on available samples of PIP implants, to consult with Australian and international experts (including with scientific, clinical and consumer representatives), to monitor the emerging Australian and international evidence, and to maintain regular and ongoing communication with international regulators including the FDA and European authorities.

The Australia regulator, the Therapeutic Goods Administration (TGA) continues to thoroughly gather evidence about the safety of these devices, including by:

• conducting scientific tests on available samples of PIP implants, including explanted devices;
• consulting with Australian and international experts (including with scientific, clinical and consumer representatives), to monitor the emerging Australian and international evidence;
• working closely with international regulators including the FDA and European authorities;
• regularly updating its public advice as new evidence emerges.

The TGA wrote to all implanting surgeons on Monday 9 January 2012, suggesting that they contact their patients.

The Australian Government also set up a free call Breast Implant Information Line on 7 January 2012. However, this has now closed. Anyone concerned about their breast implants can access information on the Department of Health's website at PIP Breast Implants. Additionally, women who have had breast implants and are concerned could see their surgeon for advice regarding the need for clinical follow up or radiological investigation.

A Clinical Advisory Committee (CMO CAC) was convened by the Chief Medical Officer (9 January 2012) to provide him with regular and frequent advice on clinical measures, risks and benefits, and communication strategies in response to health concerns related to PIP breast implants. The committee includes senior representatives of relevant clinical and consumer groups.

The Government established access to one Medicare rebated MRI scan to check the implants of women who have (or think they have) a PIP breast implant. To find current information about the Medicare rebate for MRI services for patients with PIP breast implants, visit this Department of Health webpage. If these women develop symptoms of implant rupture, they will also be able to receive a Medicare rebate for MRI, regardless of whether or not their previous MRI was normal.

To find current information about the Medicare rebate for MRI services for patients with PIP breast implants, visit this Department of Health webpage. If you develop symptoms of implant rupture, you will also be able to receive a Medicare rebate for MRI, regardless of whether or not your previous MRI was normal.

If your GP or Specialist refers you for an MRI, your form must state you have or are suspected of having a PIP branded implant. If you have symptoms of a rupture, your GP or Specialist must also note this on your referral.

You can have your MRI scan on any MRI machine that has a dedicated breast coil and is accredited to provide Diagnostic Imaging Services.

When making an appointment to have your MRI scan, check the provider has a dedicated breast coil, as not all MRI providers have dedicated breast coils. Your MRI scan must also be provided by a specialist radiologist.

MRI providers will be able to provide you with detailed information regarding the scan and what the use of a breast coil involves.

It is important to note that you can currently take a request form for a diagnostic imaging service to any accredited diagnostic imaging provider.

Patients are not compelled to take the request for the service to the provider stated on the referral form. Both private imaging practices and many public hospitals provide diagnostic imaging Medicare services. You may wish to discuss this with your GP or Specialist when you receive your referral.

To find current information about Medicare rebates for MRI services in relation to PIP breast implants, visit this Health Department webpage.

The Government encourages bulk billing, but it is up to the provider to choose whether or not they bulk bill. There are bulk billing incentives for diagnostic imaging services, including these new MRI services. Medical practitioners, including radiologists, are free to set their own value on the services they provide. While the Government is responsible for setting the schedule fee on which Medicare benefits are based, there is nothing to prevent radiologists or any other medical practitioner setting fees that exceed those in the schedule. In these circumstances, you may be required to pay the gap between the fee charged and the Medicare rebate.

No. The authority to allow the payments for the MRI items came into effect on 12 March 2012. MRIs provided prior to this date will not be eligible to receive Medicare rebates.

Yes. If you have a Medicare card (which generally means you are a permanent Australian resident), then you are eligible to receive a Medicare rebate. The country where the implant surgery was undertaken does not affect your eligibility to access Medicare rebates, however, as for all Medicare funded services, it would need to be clinically relevant.

Normal Medicare benefits arrangements will apply, so patients can receive Medicare benefits if they wish to consult a medical practitioner. Medicare benefits will also be payable where removal of an implant and replacement of an implant is undertaken on the basis of a clinical need. Medicare does not cover the cost of breast prostheses, private hospital accommodation and theatre costs - these may be subsidised by private health insurance.

No, Medicare does not pay for prostheses, including breast prostheses. Patients with private health insurance should contact their insurer to ascertain if their policy would cover the cost of the implant.

The Department is not aware of any basis for compensation payable by the Commonwealth. Individuals should take their own legal advice as to any legal entitlements they may have.

Patients may elect to be treated through the public hospital system. A medical practitioner can arrange referral of the patient to the nearest appropriate public hospital or to a specialist who performs implant procedures in the public hospital system.

The hospital staff or the specialist can then advise the best course of action for the patient, in light of all the circumstances, which may include surgical treatment. The availability and funding of breast implant procedures in the public hospital system may vary as public hospital services are funded by the states and territories.

Information on how to do this and the forms are contained on the TGA's website at:

• Report a medical device adverse event (medical device user)

An implant is medical device and patients, relatives of clinicians should use this form to report any actual and suspected problems with a medical device which has, or may present, a health hazard.

Online forms are available for reporting medical device adverse events.

• Medical device users are encouraged to complete the online reporting form.
• Alternatively, you can still download and complete a word or pdf copy of the form.

Issues experienced in completing the online medical device adverse event reporting form should be directed via email to iris@tga.gov.au or phone 1800 809 361.

The report will be investigated and you may be contacted by the TGA for further information.

The form can be filled in while on the website however, the form must be saved to your computer and/or printed out. The form can be sent via email, fax or mail. The contact details are provided at the end of the form.

• Medical device adverse event reporting form for use by medical device users (pdf,101kb)
• Medical device adverse event reporting form for use by medical device users (Microsoft Word,142kb)