TGA Suspended Textured Breast Implants in Australia related to BIA-ALCL
Breast implants were recently in the news when the TGA suspended specific types of implants in Australia.
Does this TGA action mean breast implants are now banned in Australia?
No. This regulatory action is a suspension and request for further information from suppliers and manufacturers. It is essentially a precursor to a potential TGA recall and breast implant ban (a 6-month suspension of manufacturing permissions for certain textured implants and tissue expanders), not an actual ban.
However, a TGA suspension essentially has the same effect as a ban, for the interim time (e.g., the TGA is suspending manufacturing and implementing a recall of non-implanted breast prosthesis until further safety data and SAEs such as BIA-ALCL are collected and assessed by health experts, medical device safety investigators and health statisticians over the next 6 months).
Breast Implant Brand Suspensions
Suppliers have 6 months to supply additional safety data about their breast implant products, along with the following,
- Numerous brands of textured implants were suspended and/or recalled as they appear linked with a rare form of cancer, BIA-ALCL.
- Details of the breast implant brands suspended and/or being considered for bans by the TGA are listed below and/or can be found on the TGA’s website.
- The TGA is recommending potential bans and/or recalls of breast implants, so in September 2019, the TGA temporarily suspended manufacturing permits for suppliers of particular types of implants.
- Suppliers of these implants have 6 months to provide further safety study data to the TGA’s expert panel.
- Further breast implant assessments and/or ban or recall recommendations will be decided next February, in 2020.
TGA Ban on Implants: Facts, Figures and Faq’s
Update on breast implant bans in Australia from September 2019 and what patients need to know. If you have symptoms of BIA-ALCL or related concerns, see your original Breast Surgeon and/or health care team immediately for assessment. This information is based on data as of September 2019, when the TGA announced its ban on specific types of breast implants.
Which Types of Breast Implants were Banned in Australia by the TGA?
- There is a temporary suspension with a view towards a potential recall/ban on various types of breast implants (per the TGA)
- Types suspended include textured implants and tissue expanders as shown in the table below.
Excerpt and below table from the TGA’s published alert about breast implants and BIA-ALCL
‘The TGA has decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia. However, even if your breast implants are being cancelled, suspended or recalled, medical experts do not recommend removing them if you do not have symptoms of BIA-ALCL. This is because BIA-ALCL is very rare, and the risk of undergoing surgery could be higher than the risk of developing BIA-ALCL.’
What are the details of the TGA breast implant ban?
- The TGA put a temporary suspension (and are proposing a ban) on certain types of textured implants
- They are proposing cancelling, suspending, and/or insisting on a recall of several types and brands of textured breast implants used in Australia, in relation to evidence that some forms of textured implants are associated with a higher risk of developing Anaplastic Large Cell Lymphoma (ALCL or BIA-ALCL).
Brands impacted by the TGA suspension (ban, recall) for breast implants include:
- ‘Natrelle’ implant models marketed by Allergen
- Johnson & Johnson
- Euro Implants
- JT Medical
More information on impacted breast implant brands.
What does BIA-ALCL stand for and what is the risk ratio of BIA-ALCL?
- BIA-ALCL stands for Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL).
- Estimated risks of developing BIA-ALCL from breast implants is between 1 in 1000 to 1:30,000 to 1 in 100,000.
Most health professionals and Surgeons agree the risk of BIA-ALCL is rare, far rarer than breast cancer, for example, when evaluated in terms of the number of implant patients without BIA-ALCL and the number diagnosed with ALCL.
- BIA-ALCL also appears linked with specific types of breast implants (not all breast implants are linked with BIA-ALCL).
- Certain grades of textured breast implants have led some experts to believe that highly textured implants (grades 3-4) may allow for bacterial growth to occur around the implants, versus fluid accumulation/bacterial growth ratios found for smooth implants.
No ‘smooth’ breast implant patients have been diagnosed with this disease, as of the time of publication and after several years of BIA-ALCL data collection and research)
Do implants lead to breast cancer?
BIA-ALCL is NOT breast cancer, but rather a cancer of the immune system.
- BIA-ALCL is believed linked to bacteria and/or fluids that develop around certain types of breast implants, primarily textured ones.
- The illness is thought to presents around 3 to 7 years after breast prosthesis implantation, with a 7 year incubation period being most frequently quoted.
What are the signs and symptoms of BIA-ALCL?
- Symptoms can vary from person to person.
- Swelling, pain and/or lumps in the breast should be medically assessed/investigated, as should any other unusual or concerning symptoms or changes to the breast(s).
- The Breast symptoms listed above should be investigated in women with or without breast implants, as any changes, pain, swelling or lumps or bumps in breasts can indicate an underlying health condition including cancer or early-stage BIA-ALCL.
How many people in Australia or New Zealand have been diagnosed with BIA-ALCL?
- Estimates vary and figures are being adjusted.
- It is believed 107 Australian women have been diagnosed so far with BIA-ALCL.
Is BIA-ALCL common or rare? What are the real risks?
- The disease is extremely rare, given 107 diagnoses so far out of an estimated 250,000 women with breast implants in Australia.
- This figure is not a final figure, however; and experts disagree on risks (the risk range for BIA-ALCL is 1:1000 to 1:100,000 per estimates from various statisticians).
- A new breast implant database and breast implant patient tracking database will help refine and solidify this estimate as well as incidents of BIA-ALCL.
Is it true that BIA-ALCL is only linked with textured implants vs smooth implants?
- Data is still being collected but so far, no cases of BIA-ALCL involve smooth implants.
- At this time, then, it appears the surface texture of the breast implants may be associated with the formation of fluid and/or bacterial accumulation, and/or inflammation, in the breast implant area, which can eventually result in ALCL in some patients.
- While fluid/bacteria build-up can happen on some textured implants for a minority of patients, this may be associated with ALCL; yet it is still quite rare according to the statistics currently available.
The TGA is giving some manufacturers of textured implants a chance to provide additional safety data on textured breast implants for the next 6 months. The TGA has recommended a ban and recall, but currently, that is in the effect of a TGA action to SUSPEND the use of certain types of breast implants (textured ones) for 6 months before deciding based on further evidence of the association and risk factors including risks vs benefits of breast reconstruction for mastectomy patients.
Based on current data, it appears only textured breast implants are linked thus far with BIA-ALCL, not smooth breast implants.
- It is not yet known whether other factors, e.g. patient variables, may have an impact as well as the texture of the implant.
- The condition risk ratio is also not known with a degree of certainty, albeit appears rare in terms of 1:1000 to 1:80,000 according to available data and statisticians.
Is BIA-ALCL curable?
- Early diagnosis of BIA-ALCL appears to allow for effective treatments of BIA-ALCL (cancer-related to breast implants, again, not breast cancer but a cancer of the immune system)
- Treatment for BIA-ALCL is usually surgical removal of the implants; often, if discovered early, that is the only treatment needed other than potential breast modifications or enhancements using other means (this may be limited in certain patients with little natural breast tissue)
What is the recommended treatment for BIA-ALCL detected early?
Early diagnosis is helpful in treating BIA-ALCL
- Treatments for BIA-ALCL can vary from patient to patient.
- Most treatments require removal of the textured breast implants.
The success rates for treating BIA-ALCL in early stages are encouraging, and why it’s important to see your Surgeon and/or medical team if you have any symptoms of concern after having breast implants; and to stay observant.
- Treatment for BIA-ALCL often does involve removal of the existing textured implants (early-stage detection)
- Treatment may also involve other therapies, such as chemotherapy if required (such as for late diagnosis)
Should I remove textured implants?
FAQ: ‘I have textured implants; should I remove my textured breast implants as a precaution surgery to prevent BIA-ALCL?’
- Implants that are in place, and not causing any concerns or symptoms, are not being recommended for removal surgery per the TGA (and much other health and safety experts agree that removal of implants without signs, concerns or symptoms is not thought necessary as many women with implants remain healthy and fine).
- It’s important to remember that this is a rare disease – while statistics vary, 1:1000 to 1:80,000 is considered rare.
- Breast cancer risks, for example, are about 1:8 (around 12%) compared to 1 in 1000 for BIA-ALCL as the currently anticipated worst-case risk ratio (subject to data being collected) and compared to a 1 in 80,000 risks also proposed by statisticians
The TGA and other Surgeons have expressed concern that some unscrupulous surgeons will prey on women who have anxiety about BIA-ALCL even without symptoms or even with smooth implants vs textured ones.
Is it necessary to remove all textured breast implants to prevent BIA-ALCL?
- However, it is not recommended to remove implants if no signs or symptoms are present; and remember, all surgery carries risks.
- The reason is that there may be more factors involved in BIA-ALCL developing than JUST the texture of the implant alone; this has not yet been determined and is part of why the TGA is giving manufacturers another 6 months to provide more safety data.
In other words, the TGA’s recommendation to suspend (or ban and recall) certain types of textures implants is, at the current time, a temporary measure while further breast implant safety and BIA-ALCL risk data is being assessed.
Further actions by the TGA to ban or recall either breast implants and/or tissue expanders is expected after they meet again with experts, to review available safety data, around February 2020. BIA-ALCL is thought to have a 7-year incubation period, but this can vary. See your Surgeon or Medical Team if you have any signs or symptoms of BIA-ALCL or other breast implant-related concerns. The TGA does not recommend removal of existing breast implants where no symptoms are reported.
ASAPS and the Minister of Health are anticipated to be encouraging a meeting between ASAPS, health experts and the TGA to discuss the TGA’s recommendations for breast implant bans and recalls.
The ASAPS believes that a broad ban on textured implants and tissue expanders will seriously limit mastectomy patients and other breast cancer survivors from reconstructive breast surgery shown to have a significant impact on self-esteem and positive psychological adjustments after radical mastectomy surgery in relation to breast cancers and genetic breast deformities.
The TGA will have an update on its recommended bans or recall issues for breast implants and tissue expanders when they converge again after evaluating further safety data from experts, patients, manufacturers and other stakeholders.
The Future of Breast Implants
The next TGA breast implant recommendation update is expected to occur around February 2020.
If you have concerns about existing textured breast implants or any changes to your breasts, see your original breast surgeon or medical team immediately for assessment. You can phone our team on 03 8849 1444.