Be informed and aware, but don’t be afraid
Lately there has been a lot of publicity about certain types of breast implant products and possible links to Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL.
This has been in response to a recent review by the Therapeutic Goods Administration (TGA) of breast implant products in Australia, which has led to new, tighter controls.
We understand that for some women who have breast implants, and for their families and loved ones, the publicity around this issue would naturally be causing anxiety and concern.
This is why it is very important that you have all the information you need to make the right decisions about your health.
Action being taken by the TGA to tighten regulation around these products will ensure:
- product manufacturers and suppliers are held to the highest standards of safety
- clinicians are aware of all the risks of use, and communicate these with their patients
- consumers are able to make informed decisions about their health and wellbeing that are right for themselves, their families and their loved ones.
Key outcomes of the review
The key thing to remember is that the incidence rate of BIA-ALCL is very rare.
However, the TGA is taking this regulatory action in order to make sure the small risks associated with breast implant products are tightly managed.
We want tighter controls while we conduct further investigation and monitoring to ensure rigorous oversight of the whole breast implant market, now and into the future.
We have decided to suspend the use of some implants, and put tighter restrictions and requirements on others, while we work to improve safety and address health concerns.
We are requiring suppliers to work harder to assure both the TGA and Australian consumers that their products are acceptably safe to use.
Some products have been temporarily removed from the market pending further monitoring and while sponsors work to meet changed requirements for supply in Australia. This includes providing comprehensive information to clinicians and consumers about the risks associated with certain products.
What you need to do
The TGA recognises that women may decide to get breast implants for a wide range of complex and personal reasons.
It is important that you and your family are as informed as possible as you work through the process of making that decision.
It is very important that women with breast implants feel confident and safe in their choice. We want to be very clear that the TGA’s decision to tighten regulations around some products is about managing associated risks, and making sure you have all the information you need to make the right decision for you.
Following our review, medical advice for all implants is as follows:
- If you have breast implants, and no symptoms, you need to monitor your own health and get regular clinical check-ups, as per the usual process for these kinds of procedures.
- If you begin to develop symptoms, such as itchiness, a rash, swelling or hotness, pain, discomfort or a lump in your breast or armpit, please contact your surgeon or GP (who can refer you to an appropriate surgeon) to determine whether or not removing your implants is advisable.
- If you are considering getting implants, the TGA wants to make sure you are completely informed about risks before you make that decision.
- The risks associated with BIA-ALCL are in fact less than the risks posed by proceeding with any unnecessary surgeries, and this needs to be taken into account when you are considering your options.
Evidence-based advice is that removal of breast implants is NOT required in a person without symptoms.
If you have any other questions or concerns, of course we encourage you to talk to your doctor or surgeon.
Visit the Current status of breast implant products in Australia webpage for a full list of affected products.
When the TGA suspends a product, it means it is temporarily not allowed to be included on the Australian Register of Therapeutic Goods (ARTG). In the case of breast implant products, the sponsors/manufacturers of the suspended products have six months to address the TGA's concerns.
In the meantime, un-implanted stock is being recalled and new patients will not be able to receive those products. If the sponsor is not able to address the TGA’s concerns within the six-month period, the products will be cancelled. They may be re-added to the ARTG at the discretion of the TGA and made available again if we are satisfied that the required adjustments have been made.
All breast implant devices are subject to new conditions in order to be supplied in Australia. This applies to existing products and any new products that may enter the market.
All breast implant devices will now have the following tighter conditions imposed on them in order to be included on the ARTG:
- all cases of BIA-ALCL must be reported to the TGA within 10 days of the sponsors being notified.
- new six monthly reports from sponsors – covering supply data, details of all adverse events, and all complaints, both in Australia and world-wide.
- The risk of BIA-ALCL must be included in clinicians' Instructions for Use of all breast implant and tissue expander devices.
- patient information leaflets must include warnings about the risk of BIA-ALCL.
These new conditions will enable the TGA to more closely monitor what is happening with these devices and the impact they may be having on patients, and to ensure clinicians and patients are fully aware of any associated risks.
Yes. In July 2019, Allergan withdrew the Biocell Natrelle range macro-textured implants (ARTG numbers 175422, 175425, 175420, 171512, 171475, 171387, 171388, 169956) and tissue expanders (ARTG 175797) due to the risk of BIA-ALCL. The sponsor issued a recall of all un-implanted stock.
Emergo Airxpanders also removed two of its tissue expander products in 2019, and a small number of other products have either been removed by the sponsor or the TGA over the last 20 years.
Breast implant products that have been cancelled and are no longer available are referred to as 'legacy implants'.
View the Current status of breast implant products in Australia webpage for a full list of legacy implants.
The most accurate way to determine what breast implant products you have is to check the ARTG number. This may be provided to you with your paperwork at the time of surgery, if not, you should contact your surgeon for this information.
If the implant has been inserted in the last three years, it is also possible that your surgery and device has been registered with the Australian Breast Device Registry( ABDR). You should contact the ABDR to obtain more details of your implant.
There is no need for immediate action if you have no symptoms. If you experience any changes in your breast/s, see your GP or surgeon. You can also discuss a plan for regular follow up review with your surgeon.
If you have any concerns, always see your doctor. However, the risks associated with any surgery may outweigh the risks of leaving your implants in if you have no symptoms. If you choose to have your implants removed with no medical need to do so, it may not be covered by Medicare.
Look out for any swelling or a lump around the armpit, a rash, itchiness, warmth, pain or discomfort.
Medicare covers a proportion of surgery required to remove an implant where there is a medical need.
About the TGA
The role of the TGA is to ensure that for every decision you take about your health, you have access to as much information as possible about risks and benefits, so that your decision is an informed decision.
Our job is also to take every step to ensure that medical goods and devices supplied in Australia are of the highest quality, and have the highest level of safety and efficacy possible.
The safety and wellbeing of consumers is our highest priority.
We work in partnership with industry to make sure the medical goods and devices available to Australian consumers are world-class, reliable and safe.
In all cases this means we must take a risk management approach.
The TGA engages a scientific risk management approach to all our regulatory work.
Informing you about new action around breast implant products is to ensure you are as informed as possible about risks and benefits.