Textured Breast Implants
A statement from Re. Plastic Surgery in regards to the ongoing review of textured breast implants by the TGA.
Yesterday The TGA (Therapeutic Goods Administration) notified manufacturers that certain textured breast implants may be removed from the market and others may be suspended for 6 months for review depending on the nature of the texturing of their surface. This includes Mentor implants used by Re.
This is a notice of intent only and nothing has changed in legislation at the present. The breast implant manufacturers will have until the 24th of July to respond to this proposal. The TGA is responding to international scientific papers, including many from Australia, which show a possible link between the degree of texturing of an implant and the risk of developing a Breast Implant Associated Anaplastic Large Cell Lymphoma. (BIA: ALCL) Until the TGA announce their final decision, textured implants and tissue expanders are available for insertion
The latest figures from world experts put the rate of developing ALCL with Mentor implants at 1 in 86,000 patients. The condition starts on average 8 years after surgery and presents with swelling. All current evidence suggests if your implants are removed within a year of developing swelling then you are cured.
There are other manufacturers that have textured implants with rates of up to 1 in 1000. We do not and have never used those implants.
We are unaware of any new information that has led to this proposed action by the TGA, but they seemed to have lumped all texture implants in the one basket.
It is important to understand that the proposed suspensions are proposed and that no decision has been made to suspend MENTOR® products at this time. The TGA also affirmed that because BIA-ALCL is rare, experts do not recommend preventative removal of breast implants where there are no problems with the implant. Until a decision is made by the TGA, all Mentor products will remain available for use in Australia.
For our patients, if you have not experienced any change in your breasts then there is no reason at all for concern.
If you have experienced change then we would like to see you as soon as possible.
If you have not experienced any change but would still like to see us to discuss this in person then we would be happy to make an appointment.