TGA Suspension of Textured Implants
Today (11th July), TGA (Therapeutic Goods Administration) has proposed regulatory actions to susped or cancel texture breast implants. It is a proposal only, NO DECISION has been made to suspend ANY implants at this time. Implant companies have until 24th July to submit their reports, and further decisions will be made with regards to regulatory actions. Currently, there is no proposal or intention to RECALL any implant products.
This is in response to an increase in the incidence of breast implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The risk of developing this disease is very rare, and range from 1 in 1000 to 1 in 10,000 depending on the type of texturing of the implant. There are couple of brands which have much more aggressive texturing, with higher incidence of ALCL assocaited with their textured implant. Mentor is NOT one of them. However, amongst the implants in the TGA list (under investigation for the above proposal) are Mentor Implants, this is despite Mentor implants having one of the lowest incidences of BIA-ALCL. Mentor implants are used by a significant proportion of plastic surgeons in Australia, including Dr Vrtik. We use a range of breast implants from Mentor, both textured and smooth. If you have had breast reconstruction after breast cancer, your breast implant would be textured, as all reconstructive pear-shaped implants are texture to prevent rotation and movement of the implant. If you have had a cosmetic augmentation, or enlargement of the breast, then your implant could be either smooth or textured.
BIA-ALCL has very typical presentation of breast swelling or palpable lumps within the breast or the armpit. Diagnosis is usually made from the fluid around the implant and treatment is removal of breast implant with the capsule. Those who have delayed presentation will require adjuvant chemotherapy. Mortaiity rate is extremely low.
Currently, due to rarity of the disease, it is NOT recommended for people to have their breast implant removed if they are asymptomatic. A minimum of 2-year implant checks is recommended and this is offered to all of our implant patients, with annual recall letters to all our patients with breast implants.
If you would like more accurate information, please read the TGA Announcement HERE. If you would like to discuss your concerns further, please do not hesitate to contact us for an appointment with Dr Vrtik. At your appointment, she will discuss with you the type of breast implant used for you in your surgery, symptoms and signs associated with the disease, the recommended ongoing monitoring, and she is also happy to discuss any questions or concerns you may have. Please be aware that if there is any actual recall or suspension of Mentor implants, you will be contacted via email by our office. To make sure that you are kept informed with the latest news, please take the time to ring our office and check that we have your most up-to--date contact details including email. You could also revisit our blog on the website for more news after TGA updates their proposal early next month.
This announcement by TGA should not incite panic or stress, as it is a precautionary move with patient safety in mind. At our practice, we are also committed to patient safety as our foremost priority, and Dr Vrtik would be more than happy to have an honest discussion with you if you have any major concerns.
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