A major health warning has been issued after eight types of breast implants were found to have possible links to a rare form of blood cancer, with all of the models urgently recalled across Australia.
The Therapeutic Goods Administration (TGA) issued the warning after reports of around 100 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma in Australia, including four deaths. It means all breast implants and breast tissue expanders that are currently included in the Australian Register of Therapeutic Goods (ARTG) will now be regulated, while eight will be suspended completely.
The implants will remain banned for the next six months until the TGA has time to investigate the possible links. This form of cancer develops in the scar tissue that surrounds the implant and may even, in wort cases, spread to lymph nodes near the breast. When bacteria collects in the spaces and grooves around the implant, it can cause infection which in turn can spark an immune system response.
The findings came as part of a wider review into Australia’s supply of implants and tissue expanders and on top of the suspensions, two industry sponsors have cancelled supply of their highly textured implants and tissue expanders. Unused stock will be recalled, but the TGA insisted people who have the implants will not need to have them removed at this stage if they are not showing any symptoms.
“Patients who have breast implants, or have previously had breast implants should regularly check their breasts and see their doctor if they notice any changes or have any concerns,” the TGA said in a statement. The suspensions and bans underway will affect 13 per cent of the supply of breast implant devices on the market by volume.
Currently, no models of breast tissue expanders have been suspended, which are used in women for breast reconstruction surgery following a mastectomy. However, all other breast implant and tissue expander devices must now meet certain new conditions of supply.
While all cases of breast implant associated ALCL (BIA-ALCL) must be reported to the TGA within 10 working days, manufacturers will also need to provide six monthly reports of Australian and world-wide supply data, complaints and adverse events to the TGA. Meanwhile, “clear, written information about the risk of BIA-ALCL must be provided with all devices, to both clinicians and patients”. To find out more about the recall, see the TGA website.
The Australian Society of Plastic Surgeons have applauded the decision, insisting it will mean women who require reconstructive surgery following breast cancer will receive the best care. Society president Gazi Hussain said in a statement: “These actions balance minimising risk for women seeking breast implants, while also ensuring women who require reconstructive surgery following breast cancer aren’t restricted in their options.”
Among the eight implant models suspended are the ‘Nagor Mammary Implants Gel-filled-textured’, the ‘9-cell CoGel gel-filled Nagor mammary implant range – textured’ and the ‘Impleo gel-filled Nagor mammary implant range – textured’. Others include the ‘Anatomical Breast Implants – Textured – High Cohesive Gel’ and the ‘Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant’.
The ‘Cristaline Paragel Cohesive Gel Implant’, the ‘Sublime Line, Microthane, Silicone gel filled Mammary Implants’ and ‘the 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants’ will also be recalled.
The TGA stated the devices will no longer be able to be supplied, imported, or exported from Australia for the next six months of the suspension, which takes effect on October 25.
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