THE TGA & TEXTURED BREAST IMPLANTS

Were textured breast implants banned? 

On the 2nd of August, 2019, the TGA posted an announcement that implant manufacturer Allergan was issuing a voluntary recall of their macro-textured breast implants and tissue expanders (this recall applied to current shelf-stock, and not patients who currently have these breast implants). Since this announcement, the public has been awaiting a verdict from the TGA regarding the action they choose to take on other varieties of textured breast implants. On the 26th September this update was posted, and created significant media attention and patient concern. The update stated that the TGA has decided to take regulatory action in relation to all breast implants and tissue expanders sold in Australia. This includes the suspension (not ban) and recall of a few select implants, namely the Nagor, Emagin, Cristaline, Sublime, and 4Two line varieties. The suspension states that these devices will no longer be supplied, imported, or exported over the 6 month suspension period, and that all un-implanted products will be subject to recall (ie. those products on hospital shelves). The TGA also states that this suspension can be revoked if concerns about the devices are addressed by manufacturers to the TGA’s satisfaction. 

In addition to the announcement of this suspension, the TGA includes a table with an extensive list of implant varieties that were subject to a set of conditions. These conditions include more involved patient and practitioner education, and more comprehensive paperwork. There was significant confusion regarding this section of the article, as many patients believed this extensive list of implants are subject to recall. It is important to note that the implants in this secondary table are simply under new guidelines with regard to reporting, instructions for use, and patient information. These implants are not being considered for suspension, nor recall. 

Why were textured implants suspended? 

The rationale behind the suspension, recall, and imposition of additional conditions lies in the reported link between textured breast implants and anaplastic large cell lymphoma (ALCL). Breast implant associated ALCL (BIA-ALCL) is a rare disease of the T-cells, which is said to be caused by a reaction to bacterial growth. Researchers propose that due to the high surface area of some textured implant varieties, they can create a host for bacteria and may increase the likelihood of ALCL developing for some patients. The current estimated risk rate varies depending on the type of implant, but can be between 1 in 4,000 for more highly textured (polyurethane) implants, to 1 in 86,000 for lower surface area implants. The risk remains extremely low, and can also be caused by genetic predisposition. To date, there have been no cited cases of BIA-ALCL in women with smooth implants. The link between breast implants and ALCL should not be of significant concern to patients with breast implants. According to the Australian Society of Plastic Surgeons, conservatively there are 35 million women in the world with textured implants. Of this 35 million, there are just over 500 confirmed cases of BIA-ALCL. This suggests the disease affects an extremely small percentage of the total breast implant population, which is predicted to decrease over time as existing patients are educated regarding the signs, symptoms, and proper follow-up, and future patients are implanted with smooth surface varieties. 

What are the symptoms of ALCL?

For patients with textured implants concerned about BIA-ALCL, there are a number of signs and symptoms to be aware of. Firstly, any changes in the appearance or feel of the breasts should be flagged with your operating surgeon, or a qualified review clinic such as The BRAS Clinic. A key symptom to look out for is a large amount of fluid in the breast capsule developing, with a dramatic change in the volume or size of the breast that is not related to other pain or trauma. If you experience these symptoms, it is recommended that you have a routine ultrasound as well as a fine-needle aspiration to test the fluid in the implant for ALCL. When detected at this early stage, ALCL is very treatable as it is contained to the capsule, and can be treated through removal of the implant and capsule. 

What should I do if I have textured implants?

The BRAS Clinic recommends for all patients with textured implants to not be concerned or alarmed by the TGA’s announcement. The governing body has made clear that there is no recommendation to have these implants removed or replace, as the risk of surgery and general anaesthesia is far greater than that of BIA-ALCL. Rather, we recommend a physical check-up at the BRAS Clinic where you will receive a referral for a routine ultrasound to ensure there is no excessive fluid around the implant, and no signs of rupture or other complications. You can make an appointment with the BRAS Clinic by contacting us today. 

What breast implants should I get if I am considering breast augmentation?

If you are a patient considering breast augmentation, you should be thinking about mitigating future risk by choosing a smooth surface implant. The BRAS Clinic strongly recommends Motiva implants, as they are the most advanced, and safest implant technology on the market. Their silk-surface nano-technology means that each contact point of the Motiva implant surface is pre-determined and smaller than a single cell, preventing the inflammatory process progressing and reducing the risk of ALCL.