Women with breast implants and breast tissue expanders are being urged to see a doctor if they notice any abnormalities, after regulators announced a major crackdown over cancer fears.
The Therapeutic Goods Administration confirmed overnight that eight breast implant models have been suspended from supply in Australia for six months, while safety and performance concerns are addressed.
The crackdown on the implants comes following reports of around 100 cases of a rare cancer, known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in Australia, including four deaths.
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“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,” the TGA said.
“Any stock of these un-implanted devices in the market will also be recalled during the suspension period.”
In addition to the suspensions, the TGA said that in some cases, the sponsor had chosen to cancel the inclusion of their implant in the Australian Therapeutic Goods Register.
“Two industry sponsors have cancelled the supply of their highly textured implants and tissue expanders since the Review was initiated,” the TGA said.
“The suspensions and cancellations affect thirteen per cent of the supply of breast implant devices on the Australian market by volume (based on 2018 data).”
Breast implant and tissue expander devices that have not been suspended now face extremely strict conditions of supply.
“If the safety and performance concerns around the suspended implants are not resolved, or the conditions of supply for the other products are not complied with, the devices may be cancelled from inclusion in the ARTG and thus not be able to be supplied in the Australian market,” the TGA warned.
Whilst the unused breast implants are being recalled, the regulator says removal of the implants is “not required in a person who has no symptoms or concerns.”
“Patients who have breast implants, or have previously had breast implants should regularly check their breasts and see their doctor if they notice any change in the breast or armpit such as swelling, a lump or pain.”
More information can be found here.