On 26 September 2019 the Therapeutic Goods Administration (TGA) published an update advising of the outcomes of their review into breast implants and breast tissue expanders. You can read the entire update here: https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
In summary, the TGA has taken the following regulatory action:
- Suspended “macrotextured” grade 3 and 4 and some “microtextured” implants for a period of 6 months;
- Imposed conditions on inclusion, of all breast implants that are still available, in the Australian Register of Therapeutic Goods (ARTG);
- Imposed increased reporting requirements on implant manufacturers and suppliers for providing information about adverse events, including cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL); and
- Some manufacturers and suppliers chose to cancel the inclusion of their implant devices during the period of review and as such are already no longer available on the Australian market.
What is a suspension?
When a product is suspended by the TGA, it is considered to no longer be included in the ARTG. This means that the product cannot be “imported, manufactured, or exported from Australia” by the manufacturer or supplier for the period of the suspension. It also means that all implants that have not been implanted will be removed from shelves.
Comment from the Australian Society of Plastic Surgeons
The Australian Society of Plastic Surgeons issued a media release supporting the regulatory action taken by the TGA. The media release stated:
“The Australian Society of Plastic Surgeons has commended the TGA’s regulatory changes following its review of breast implants and breast tissue expanders as a sensible and measured response that will improve safety of women whilst preserving options for women, particularly those requiring reconstructive surgery following breast cancer treatment…”
TGA’s advice to women with textured implants
The TGA stated in their update that implant removal is not required in someone who does not have any symptoms or concerns. It is advised that if you do notice any changes in your breasts or experience any symptoms such as “swelling, a lump or pain” that you should speak to your treating doctor. If you do have concerns or require further information you can visit the “Breast implant hub” at https://www.tga.gov.au/hubs/breast-implants. It is a resource provided by the TGA that aims to provide information and support about breast implants.
Turn to Turner Freeman
Sally Gleeson, medical negligence partner and her team of lawyers are experienced in cases involving complications of breast augmentation surgery. If you have suffered complications as a result of a breast augmentation surgery, please contact us so that we can assess your case. Alternatively, if your surgery was performed by The Cosmetic Institute, you can register your interest in our Class Action below.
Register in our Class Action
We invite you to register your interest in the class action against TCI with Turner Freeman Lawyers. It is important that you put your hand up to be counted. If you have suffered complications as a result of surgery by TCI, please register on our website and our medical negligence Partner, Sally Gleeson or one of her team members will be in touch to explain the process.