Following news last week that the Therapeutic Goods Administration (TGA) is finalising its decision on whether or not to ban textured implants in Australia, implant manufacturer Allergan have just announced a worldwide recall for all their Biocell textured implants and tissue expanders. This move comes in response to the link between textured implants and Anaplastic Large Cell Lymphoma (ALCL), a rare form of cancer which at last count had around 560 confirmed cases worldwide with 16 deaths.
The specific implants that have been recalled include Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants, Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
The Australasian Society of Aesthetic Plastic Surgeons (ASAPS) is urging Federal and State Governments to introduce a national screening program for women with textured breast implants to identify those at risk of ALCL and detect any implant ruptures, capsule formation, or fluid of seroma around the breast implant which can all be signs of implant infection. ASAPS say there is currently very little support for those patients with textured breast implants.
Dr Naveen Somia, President of ASAPS, said a screening program will help any woman feeling worried about having textured implants to be put at ease. “The clinics of our ASAPS Members have received hundreds of calls in the wake of the news that textured breast implants could be putting patients at risk of ALCL.”
Dr Somia also says there should be a social marketing campaign to support the screening program to help direct patients to the TGA website for reliable information.
Move by TGA to classify breast reconstruction as cosmetic surgery
An additional concern for ASAPS is that the TGA have moved to classify breast reconstruction as cosmetic surgery. This would deny some breast cancer patients access to breast reconstruction, proven to aid in the mental and physical recovery of patients post breast cancer. Dr Somia says it’s essential to keep breast reconstruction separate from cosmetic surgery in order to continue to support breast cancer patients. “Access to tissue expanders (which are microtextured) must be maintained. Tissue expanders are an essential component in breast reconstruction surgery, and many women would be significantly disadvantaged if these were not available. Tissue expanders are unlikely to be in situ for long enough (generally 3-12 months) to cause an ALCL if the hypothesis regarding causation is correct.
“Another vulnerable group who benefit from the use of textured breast implants are those who suffer from breast deformities due to radiation, burns, or congenital disabilities.”
It is important to note that most patients with textured implants will be fine and it is recommended that they do not need to take any action, however Dr Somia says any patient with textured implants who has noticed changes in their breasts should see a Specialist Plastic Surgeon who can do further examination to ensure the health of both the patient and their implant.