The Therapeutic Goods Administration (TGA) has announced it will “take regulatory action on all breast implant and breast tissue expanders currently included in the Australian Register of Therapeutic Goods (ARTG)”.
The TGA reviewed breast implants and tissue expanders following reports of around 100 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 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 explained: “This means 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.
‘No models of breast tissue expanders have been suspended.’
The TGA noted two industry sponsors “have cancelled the supply of their highly textured implants and tissue expanders” since the review was initiated.
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 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.
The suspensions and cancellations affect 13% of the supply of breast implant devices on the Australian market by volume.
The TGA also warned: “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.”
President of the Australasian Society of Aesthetic Plastic Surgeons (ASAPS) Dr Naveen Somia welcomed the TGA announcement as “a good day for patients”.
He commented: “This review has prioritised patient safety with the breast implants that have the highest risk BIA-ALCL suspended for six months. However, it still leaves viable options for patients on the market.”
He added ASAPS was pleased to see tissue expanders remain available, as these “are an essential component in breast reconstruction surgery, and many women would be significantly disadvantaged if these were not available”.
Dr Somia also noted: “Another vulnerable group who will benefit from today’s decision to leave the micro-textured, or Grade 2 devices on the register, are those who suffer from breast deformities due to radiation, burns, or congenital disabilities.
“It seems the TGA has listened to the advice of its independent expert review panel.”
