01 Oct Australian regulatory action on textured breast implants and breast tissue expanders
Following an extensive review including an analysis of the available statistical data, the Australian Therapeutic Goods Administration (TGA) have announced a suspension and recall of specific breast implants for a period of six months. During this time the implant company must submit additional information proving the implants’ ‘safety and performance’ to the TGA. These implants are those that have been linked to a higher rate of BIA-ALCL which are Grades 3 and 4 of “macrotextured” implants and all “microtextured” implants.
Eight models of breast implants are to be suspended from supply in Australia during this six month period, while a number of safety and performance concerns are addressed. This means that these devices will not be able to be imported, exported, or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety. Any stock of these un-implanted devices in the market will also be recalled during the suspension period.
All other breast implant and tissue expander devices, that have not been suspended, will require strict conditions of supply to be met:
- all cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) must be reported to TGA within 10 working days of the sponsor being aware of the case
- six monthly reports of Australian and world-wide supply data, complaints and adverse events are to be provided to the TGA
- clear, written information about the risk of BIA-ALCL must be provided with all devices, to both clinicians and patients
BIA-ALCL – The Facts
It is important to note that BIA-ALCL is still considered extremely rare. Keeping in mind that millions of women worldwide and around 40,000 women in Australia each year have breast augmentation with implants; there have been 23 deaths with 700 confirmed cases reported worldwide, 107 of these in Australia. The Sydney Morning Herald reported, “All Australian cases have involved textured implants, the greater the texture, the higher the risk. The chance of developing ALCL from grade 4 implants was one in 2800 breast augmentations and one in 3300 for grade 3. The risk drops off markedly for the lesser textured grade 2 (one in about 84,000).”
To see the full list of recalled and suspended implants and to learn more about the content in this article, head to the TGA website.
What we do
Dr Terrence Scamp takes a safety-first approach and tries to always use the safest and most effective products based on the latest research. Dr Scamp does not use any of the suspended implants, nor does he use any textured breast implants at all. Since they became available on the Australian market he has exclusively used Motiva smooth implants due to their high safety profile.
It is important to know the symptoms of breast implant associated cancer. The most common symptom is swelling of a breast caused by fluid build-up around the implant. But it is important to note that the majority of women with this swelling will simply have reactive inflammatory fluid , not ALCL. The diagnosis is made by drawing off some fluid under ultrasound control and examining this fluid. Get to know the normal look and feel of your breasts. Self-examine your breasts regularly, such as in the bath or shower, and include your armpits and up to your collarbone.
If you think there are any changes, or if you have any concerns, see your doctor.
Breast implant associated cancer is rare, but the risk is higher with textured breast implants. If you do not remember whether your implants are smooth or textured, or what brand they are, your surgeon or the clinic that holds your operation record should be able to advise you on these details.
We are always here to provide the relevant information and utilise our years of expertise to help patients make informed decisions. Please call the clinic if you have any concerns over your breast implants on 07 5539 1000.