TGA issues implant alert
The TGA is enhancing its regulations on all breast implants and tissue expanders sold in Australia over cancer fears.
There are growing concerns about links between certain types of breast implants and a rare form of cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), of which there have been around 100 cases reported in Australia, including four deaths.
“Eight models of breast implants are to be suspended from supply in Australia for six months, while a number of safety and performance concerns are addressed,” the TGA said in a statement.
“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.
No breast tissue expanders have been suspended, but the TGA is now requiring manufacturers report cases of the cancer within 10 days of notification.
The regulator has stopped short of recommending the removal of implants.
“As BIA-ALCL is very rare, the consensus clinical advice is that the removal of breast implants is not required in a person who has no symptoms or concerns,” it said.
“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.”