TGA announcement
On the 11th of July 2019, the Therapeutic Goods Administration (TGA) proposed the suspension and cancellation of a number of textured implant varieties due to the cited link between these implants and the risk of anaplastic large cell lymphoma (ALCL). The media coverage surrounding this proposal has been significant, and inconsistencies in reporting has caused confusion among patients with implants and the general public. There are a number of important areas of consideration when reviewing the TGA’s recommendations. In this blog post we will discuss considerations for textured implants and what it means for you.
The TGA recommended the suspension of a number of textured implant varieties. Since this announcement, implant manufacturer Allergan has submit a voluntary recall of a number of their implant types. This recall is for stock currently in distribution, and there is no recall for patients who have these implants currently. There is no recommendation for patients who have textured implants to undergo surgery for removal or replacement of implants.
Textured implants and the TGA announcement
It is important to note that the rationale for the suspension of textured implants is to mitigate any possible risk of breast implant-associated ALCL (BIA-ALCL) in future patients. At present, the risk of ALCL associated with textured breast implants remains extremely low. For macro-textured implants the risk is approximately 1 in 1,000 to 1 in 10,000. For the more commonly used micro-textured implants, the risk can be as low as 1 in 86,000. To place these statistics in perspective, the risk of any woman developing breast cancer is 1 in 8. In addition, when detected early, ALCL is generally easy to treat. According to the TGA, in about 80% of cases, the disease is detected in the early stage and cured by removal of the implant and surrounding capsule. In rarer cases, patients may require additional treatment such as chemotherapy, radiotherapy, or addition surgery.
What do I do if I have textured implants?
So what do you do if you have textured implants? Dr. Phil Richardson–Brisbane Breast Specialist—recommends that patients with textured implants book into the BRAS clinic for a routine check up. BRAS Clinic is Brisbane’s first implant review clinic, providing review services to women with implants at no out-of-pocket cost. At your breast implant review, the clinic will conduct a physical examination and provide an ultrasound referral. An ultrasound can detect implant rupture and fluid build-up. Patients will receive a call from the clinic with their ultrasound results and may be provided with a recommended treatment plan.
Women with textured implants should be aware of the symptoms that may indicate the need for a routine check-up. A severely swollen breast is the most common symptom to look out for. This swelling may be a build up of fluid around the implant. You should also look out for lumps in the breast or armpit. If you find a lump, your GP is he first point of contact as it may not be related to your implants. It’s important to understand that swelling can be caused by many factors, and the risk of BIA-ALCL remains very low. However, if you do experience any of these symptoms it’s important to stay on top of your routine check-ups. It’s equally important to continue regular mammograms. At your mammogram appointment, notify your technician of your implants.
Conclusion
In conclusion, the proposed ban on textured implants by the TGA is aimed at reducing future risk for patients. Currently, the risk associated with textured implants is extremely low. There is no recommendation from any regulator or practitioner to remove textured implants if you have them. It is recommended that patients make themselves aware of ALCL symptoms. In addition, patients should stay on top of regular checkups and ultrasounds. The discontinuation of these implants is simply to avoid any future risk.
If you have any questions or concerns, contact our Brisbane plastic surgery clinic today.