Protecting Patient Safety
Breast Implant Information Update
Breast Implant Information Update
Breast implants and anaplastic large cell lymphoma | Therapeutic Goods Administration (TGA)
30 October 2020
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 …
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Statement from ASPS on TGA breast implant cancellation
30 October 2020
“The Australian Society of Plastic Surgeons supports the TGA’s cancellation of breast implants that may have a higher risk of inducing Anaplastic Large Cell Lymphoma (ALCL) or that have incomplete safety studies. Today’s cancellation is confirmation of a suspension that occurred last September. The Australian Society of Plastic Surgeons has been working with the TGA to minimise the risk of harm to Australian women and Australian specialist plastic surgeons are contributing to global research into this rare cancer. As always our advice is for women to monitor their breasts and see their doctor if they notice any changes. BIA ALCL is a rare cancer and can be successfully treated if detected early. We would emphasize that cancellation of the implants does not mean that implants that have previously been inserted should be removed if there are no symptoms to indicate ALCL”
Dr Dan Kennedy, President ASPS
Allergan textured Breast Implants no longer to be used
25 July 2019
Textured breast implants and tissue expanders made by Allergan are being recalled from sale globally.
These implants have been linked to anaplastic large-cell lymphoma (ALCL), which is a rare cancer of the immune system. It is not breast cancer, but can develop adjacent to a breast implant. In most cases, removing the implant and the capsule around it cures the disease. The main symptoms patients should be aware of are an unusual swelling and/or fluid accumulation in the breast or around the implant. If any of these symptoms occur please see your Specialist Plastic Surgeon. Your surgeon knows the details of your implants and will assess you and if appropriate perform tests which may include a biopsy or draining the fluid and sending it for specific testing. A delay in diagnosis has been shown to have poorer long term outcomes.
ALCL has occurred associated with implants placed both for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer. It has also occurred in implants that are filled with silicone or saline. Whilst there are several hypotheses, why this texturing leads to cancer in some patients is not known.
The lymphoma is rare, given that millions of women have breast implants.
Women who have these implants, but no symptoms, do not need to have them removed. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.
“Patient safety is a priority for Allergan,” the company said in a statement, “and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”
Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products and the Australian Society of Plastic Surgery supports their withdrawal from the market.
Textured Breast Implants: What do I need to know?
12 July 2019
The TGA (Therapeutic Goods Administration) has notified manufacturers that certain textured breast implants may be removed from the market (cancelled) and others may be suspended for 6 months for review depending on the nature of the texturing of their surface.
This is a notice of intent only and nothing has changed in legislation at the present. The breast implant manufacturers will have util the 24th of July to respond to this proposal. The TGA is responding to international scientific papers, including many from Australia, which show a possible link between the degree of texturing of an implant and the risk of developing a Breast Implant Associated Anaplastic Large Cell Lymphoma. (BIA: ALCL) Until the TGA announce their final decision, textured implants and tissue expanders are available for insertion. ASPS encourage their members to consider the least textured implant that will achieve a satisfactory result for their patient.
Update regarding breast implants and BIA-ALCL
The TGA is proposing to take regulatory action in relation to a number of breast implants that have been associated with Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The TGA has formed a view regarding proposed regulatory action in relation to 31 of textured implants. The TGA is required by law to provide the sponsors of affected implants with an opportunity to make submissions in response to proposed regulatory action. The TGA will then take into consideration each sponsor’s submission when deciding what, if any, regulatory action should be taken in relation to particular sponsor’s device(s).
Specialist Plastic Surgeons’ statement on breast implants
The safety of breast implants is an issue of concern for women and the safety of our patients remains our number one priority.
However, we remind women with implants that this is a rare condition that is very curable if detected early.
Women with implants should have annual checks of their breasts and be vigilant about monitoring their breasts for signs of any changes including redness, swelling or change in shape and see their doctor if developments occur.
Members of the Australian Society of Plastic Surgeons are offering breast implant checks to patients with concerns for no out of pocket fee. To find surgeons offering this service click here.
View the TGA statement here.
Assess implants for no out-of-pocket expense consultation – 30 August 2017
Update on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA‐ALCL)
Women who are concerned about their breast implants following reports of a study linking infection caused by implants to a rare cancer, anaplastic large cell lymphoma (ALCL), should discuss their concerns with their doctor.
ASPS is developing a national register of member surgeons who are willing to see concerned women with symptoms and assess their implants for no out-of-pocket expense consultation. The patients first option should be to see the surgeon who put the implants in but if they can’t or don’t want to, then members on the register will see the patient for an assessment with a referral from their GP.
This initial consultation is an opportunity to discuss concerns. If the patient chooses to undertake further investigation or commit to a procedure, subsequent costs may be incurred.
The register can be accessed here.
FAQ’s – 28 August 2017
FAQS on breast implant associated with anaplastic large cell lymphoma (BIA-ALCL)
The Therapeutic Goods Administration (TGA) has recently provided updated information regarding breast implant associated-anaplastic large cell lymphoma.
The TGA has been posting updated information about this condition since 2011 and this updated alert was been generated following a recent expert advisory panel in view of additional generated from research performed by a joint BIA-ALCL task force with representatives from the Australian Society of Plastic Surgeons, Australasian Society of Aesthetic Plastic Surgeons, New Zealand Association of Plastic Surgeons the Australian Breast Device Registry and the Peter MacCallum Cancer Centre.
Information Sheet – 28th August 2017
Key points and facts associated with BIA-ALCL
Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)