The TGA has published Allergan’s independent decision to initiate a Medical Device Recall and Implant Hazard Alert, regarding its macro-textured breast implants and tissue expanders. Read the update.
This information hub aims to help the Australian public find information and support related to breast implants. This hub will be updated when new information arises to ensure content is current and relevant for consumers and health practitioners.
The TGA continues to monitor the safety and performance of breast implants and urges patients and health professionals to report any problems associated with these devices to the TGA.
If you are considering breast implants, read our page that covers things you should know before undergoing the procedure.
Breast implants are gel or fluid-filled pouches inserted in the breast area. People may get breast implants for many reasons, including cosmetic enhancement or reconstruction after surgery.
Breast implants differ in their size, shape, filling and surface characteristics. Most implants are either round or teardrop-shaped. They may be filled with saline (sterile salt water) or with silicone gel. The surface of the implant may be smooth or rough (textured), and different implants may vary in the amount of irregularity of the texture.
Breast implants are not lifetime devices and need to be replaced after approximately 10 to 15 years.
If you are considering breast implants, read our page that covers things you should know before undergoing the procedure.
If you are considering breast implants, you should ask your surgeon about the benefits and risks of the different types of implants.
Some of the complications and adverse outcomes of breast implants include:
- additional surgeries, with or without removal of the implant
- capsular contracture (scar tissue that forms around the implant and squeezes the implant, which can cause contour deformities)
- breast pain
- changes in nipple and breast sensation
- rupture with deflation of saline-filled implants
- rupture with or without symptoms (silent rupture) of silicone gel-filled implants
- asymmetry (one breast appears different in size or shape to the other)
- breast tissue thinning
- delayed wound healing
- skin breakdown and extrusion of the implant (the surface of the breast implant becomes exposed)
- haematoma (e.g. bruising)
- seroma (fluid build-up)
- malposition/ displacement (a breast implant moves out of its intended position)
- ptosis (sagging of the breast)
- skin rash
- dissatisfaction with the result
- breast implant associated cancer.
Breast implants with a rough (textured) surface adhere better to the surrounding tissue. This can prevent the implant from moving around, to provide benefits in some patients by reducing complications such as capsular contraction, rippling, implant displacement and asymmetry.
Consumers should remember that implants are not lifetime devices. The longer you have breast implants, the more likely it is that complications will occur and you will need to have them removed. There is no guarantee that you will have a satisfactory cosmetic outcome from any reoperation.
Breast implant associated cancer, which is also known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system. It is not breast cancer, which forms from cells in the breast, but instead a cancer of the body's disease-fighting lymphatic system and will usually grow in the fluid and internal scar tissue that develops around the breast implant. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.
The TGA strongly encourages consumers and health professionals to report all problems associated with medical devices, including breast implants. Your report helps us to monitor the performance and safety of medical devices. We investigate safety concerns, and if there is a problem, we take action to notify and protect the community.
Visit the reporting problems page to complete the online form and share any problems you may be experiencing. Please include as much information as you can, including implant/explant dates, model and serial numbers.
For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
Where to go for help
No matter how long it has been since your breast implant surgery, if you have symptoms such as swelling, a lump, pain or skin changes in your breast, you should see your general practitioner (GP). Your GP will review your symptoms and provide with you a referral to see the surgeon who performed your breast operation.
If your original surgeon is unable to see you, or you don’t remember their details, your GP can refer you to another surgeon who is experienced in managing breast implant complications.
There are a number of different types of medical practitioners who can help:
- Plastic surgeons
- Breast surgeons:
- Cosmetic physicians/surgeons
- General practitioners
You can attend the Emergency Department of your local public hospital if your GP considers that your condition needs emergency treatment. Some public hospitals may also have an outpatient breast clinic that may accept patient referrals.
Finding information about your breast implant
The surgeon who did your breast implant surgery is best placed to advise you about the type of device that was implanted. If your surgery was undertaken in a public hospital then you can contact the hospital to request the information from your medical records, if it has been recorded there.
The TGA does not hold personal information about patients and their devices. Recently the Government introduced new requirements for all implantable devices. As these requirements are implemented, patients undergoing breast implantation will start to receive a leaflet with details of the device for their records.
The Australian Breast Device Registry (ABDR) is a clinical quality registry established by the Australian Government in 2011 to track the outcomes and quality of all breast device surgery performed across Australia.
The ABDR may also hold information about your breast implant. If your breast implant surgery occurred between 1998 and 2015, your data may be held by the Australian Society of Plastic Surgeons (ASPS), who maintains legacy data from the Breast Implant Registry (BIR), a precursor to the ABDR.
Where to go if you are concerned about the quality of your health care
If you have concerns about the way your breast implant surgery or follow-up care is being handled, you should discuss your concerns with your treating practitioner or hospital liaison officer. There is also an independent health authority in each state and territory that is able to receive complaints from consumers about the health care they have received.
- ACT - ACT Human Rights Commission
- NSW - Health Care Complaints Commission
- QLD - Office of the Health Ombudsman
- SA - Health and Community Services Complaints Commissioner
- TAS - Health Complaints Commissioner Tasmania
- VIC - Health Complaints Commissioner
- WA - Health and Community Services Complaints Commission
If you wish to check the registration and qualifications of your treating practitioner, visit the Australian Health Practitioner Registration Authority (AHPRA) website. AHPRA can also receive complaints from patients about a practitioner’s conduct.
The Australian Commission on Safety and Quality in Health Care can also provide guidance in clinical concerns and direct you to the relevant assistance.
Other consumer support
You may also find the following links helpful:
The role of the TGA
In Australia, breast implants are regulated as high risk medical devices. This means that we evaluate these products for safety, quality and performance (that they will do what they are supposed to) before they can be used in surgery. The TGA also works closely with the Australian Breast Device Registry to monitor the ongoing safety and performance of breast implants.
The TGA regulates the supply of medical devices in Australia’s market. It does not regulate health practitioners or compensate patients for any injuries suffered as a consequence of their health care or use of a medical device.
What has the TGA been doing to monitor breast implants?
The TGA publishes updates on breast implant associated cancer as new information becomes available.
The TGA has been monitoring BIA-ALCL since 2011 after receiving the first adverse event report in 2009. It established an expert working group in 2016 to seek advice on BIA-ALCL and to provide consumers and health professionals with targeted information on this particular type of cancer. The working group includes plastic surgeons, cosmetic surgeons, breast-cancer surgeons, cancer epidemiologists, data analysts, public -health practitioners and consumers. The group’s advice is published on our website.
The TGA's breast implant expert working group last met on 8 April 2019 to discuss the current data on BIA-ALCL rates and correlation with type of implant. This followed decisions taken by regulators in France and Canada to remove selected textured implants from their market.
The TGA has undertaken a comprehensive review and laboratory testing of samples received from the sponsors of breast implants in Australia. Read the update.
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 due to increased incidence of ruptures and concerns that they contained unapproved ingredients.
In 2014, the TGA cancelled Cereform silicone gel-filled breast implants and associated sizers from the ARTG at the request of the sponsor, Medical Vision Australian Plastic & Cosmetic Pty Ltd.
This action was taken because the manufacturer had not fully validated the sterilisation process as required under the relevant regulations, however, this does not mean the Cereform implants were not sterile at the time of manufacture or supply. Any issues or infections relating to Cereform breast implants would have occurred soon after the surgery.
In 2016, the TGA cancelled all medical devices manufactured by Silimed from the ARTG, after an investigation found some Silimed devices were contaminated with silica and cotton particles.
Like the TGA in Australia, international regulators also monitor safety concerns related to breast implants, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). International regulators’ recent activities are summarised below.
FDA (USA regulator)
July 2019 - On 25 July 2019, the United States Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan agreed and is removing these products from the global market.
May 2019 - The United States Food and Drug Administration (FDA) released a statement on 2 May 2019 detailing the steps that it would take following a public meeting held by the FDA on 25 and 26 March 2019. The meeting discussed the benefits and risks of breast implants indicated for breast augmentation and reconstruction, including:
- breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
- systemic symptoms reported in patients receiving breast implants
- the use of registries for breast implant surveillance
- magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants
- the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
- the use of real-world data and patient perspectives in regulatory decision making
- best practices for informed consent discussions between patients and clinicians.
MHRA (United Kingdom regulator)
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to collect and analyse information from UK healthcare professionals and other sources about BIA-ALCL to build a fuller picture of the occurrence of this rare disease in association with breast implants.
The MHRA has formed an independent expert advisory group, the Plastic Reconstructive and Aesthetic Surgery Expert Advisory Group (PRAESEAG), who are reviewing the risks associated with breast implants and helping to provide further understanding of the disease and potential risks to patients. They will also provide guidance on future necessary MHRA action.
HPRA (Irish Regulator)
HPRA has not received any reports of BIA-ALCL at this time. HPRA is a member of the European task force on BIA-ALCL and is working closely with their partners to share information and develop an understanding of this disease.
Health Canada (Canadian regulator)
Health Canada, on 28 May 2019, released an update to the safety review that was being undertaken in relation to BIA-ALCL. The outcome has been the suspension of Allergan Biocell implants from the market in Canada due to the increased risk of BIA-ALCL with textured implants. The Allergan Biocell implants are the only textured implants available in Canada.
On 7 June 2019 Health Canada issued a Medical Device Recall for Allergan’s Biocell Style 168 textured, round saline filled breast implants; Style 163, 468, 363LF textured, anatomical saline-filled breast implants; Style 120, 115, and 110 round silicone-filled breast implants. This recall is based upon the rare but serious risk of BIA-ALCL. Allergan has voluntarily recalled BioCell breast implants as a precautionary measure.
The Allergan textured breast implants and tissue expanders have been withdrawn from Europe due to a lapse in the EC certification. The TGA has published a statement relating to this matter.
On 17 July 2019 the Scientific Committee on Health Environmental and Emerging Risks (SCHEER) has published a request for a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma. There are eight key issues under consideration are intended to cover reconstructive and augmentation use of breast implants. A deadline of 31 August 2020 has been indicated.
The issues being examined are listed below with a brief description of each.
- To briefly describe what are the specific clinical indications and uses for various types of breast implants.
- To briefly describe what BIA-ALCL is, what the specific diagnostic criteria are, what the state of the art treatment is, and what the prognosis of the disease is.
- To indicate what is the state of the art knowledge in terms of incidence of BIA-ALCL.
- To describe the state of the art knowledge regarding the characterisation and classification of textures of the breast implant shells (e.g. is classification possible?).
- To indicate whether a causal relationship between breast implants and ALCL can be established based on the evidence available to date. To discuss what may be the potential and if possible the most plausible pathogenesis mechanisms. To evaluate the available information on incubation time, and in relation to this, discuss the importance of knowledge on previous implants history of women developing BIA-ALCL. To evaluate if preventive explantation is warranted in case reasons for concern related to breast implants or specific subcategories of breast implants are identified.
- To describe the factors that may determine the risk of BIA-ALCL.
- In the context of ALCL to briefly describe alternatives to breast implants.
- Where relevant to identify needs for further research and the best ways to collect the missing data regarding breast implants and ALCL.
ANSM (French regulator)
The Agency of Medicine and Health Products Safety (ANSM) held a public forum on 7 and 8 February 2019 to hear submissions relating to breast implants.
The minutes from this meeting, along with the information from the FDA public meeting, peer-reviewed publications, and their legislation, are the basis for the decision by the ANSM, published on 4 April 2019, that macro-textured and polyurethane-coated implants would no longer be supplied in France.
RIVM (Netherlands regulator)
The National Institute for Public Health and the Environment (RIVM) in the Netherlands published the findings of its review of BIA-ALCL on 17 May 2019. As a result, the Minister has decided that the devices will not be subject to further regulatory action in the Netherlands, at this time.
Swiss Medic (Swiss regulator)
Swiss Medic intends to wait for the findings of the European Task Force on BIA-ALCL and SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) to further evaluate the disease BIA-ALCL before making any regulatory decisions.
Swiss Medic has sought further clarification of the available information from Swiss Plastic Surgery who have recommended the use of smooth implants rather than textured implants where permitted by the clinical situation.
BfArM (German regulator)
The Federal Institute for Drugs and Medical Devices (BfArM) has not taken any action; the emphasis has been placed on an informed decision by the patient and physician according to the current state of knowledge.
MHLW (Japanese Regulator)
The Ministry of Health, Labour and Welfare (MHLW) following advice from its advisory body, the Pharmaceuticals and Medical Devices Agency (PMDA), issued an Administrative Notice to Allergan on 7 June 2019, requiring them to revise the precautionary statements provided in the Package Inserts in Natrelle breast implants. Allergan had until 8 July 2019 to comply.
HSA (Singaporean regulator)
The Health Sciences Authority (HSA) convened an Expert Panel in February 2019 which advised that textured surface implants appeared to be associated with a higher risk of ALCL. However, the risk factors associated with the disease are still unclear. The HSA has taken the precautionary measure of disallowing the sale of Allergan Natrelle breast implants in Singapore since April 2019.
SFDA (Saudi regulator)
The Saudi Food and Drug Authority (SFDA) has issued a Field Safety Notice advising surgeons and patients to carefully consider the use of textured implants.
Anvisa (Brazilian regulator)
The Brazilian Health Regulatory Agency (Anvisa) has suspended Allergan’s licence to supply due to suspension of the CE certificate.
On 25 July 2019, Anvisa issued a recall notice for Allergan Natrelle Textured Tissue Expander and Allergan Accessories, Natrelle Textured Allergan Breast Implant, and Natrelle Textured Double Lumen Breast Implant and Allergan Accessories covering all models and lot numbers for these products. At this stage they have not made a recommendation for removal or replacement of BIOCELL textured breast implants or tissue expanders in asymptomatic patients.
The Australian Government established the Australian Breast Device Register (ABDR) to track the long-term safety and performance of breast implants as well as identify best surgical practice to help safeguard health outcomes for patients. The registry is independently managed by Monash University and is endorsed by Australian surgical societies representing plastic and reconstructive surgeons, cosmetic surgeons and general breast surgeons.
The registry collects comprehensive information about breast implants, breast tissue expanders and dermal mesh. Currently, the registry holds breast device details for more than 36,000 patients, which has been provided by more than 460 surgeons from public and private hospitals and day surgeries in all states and territories.
Research reports and other publications that use ABDR data will not contain any identifiable information about you. More information about ABDR data privacy is available on the ABDR website. We encourage you to contribute to the ABDR, but you may choose to opt-out if you wish.
The expert working group, in conjunction with the TGA, strongly endorses the ABDR as the repository of all information relating to breasts implants, including BIA-ALCL.