Table 2. BIA-ALCL warning in breast implant package insert*.
| If you have breast implants you have a very small, but increased risk of developing breast implant associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. In the cases that have been spread beyond the scar tissue and fluid near the implant, rare cases of death have been reported |
| Most patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as swelling, pain, lumps, or asymmetry that developed after their initial surgical sites were fully healed. In the cases known to FDA to date, BIA-ALCL was diagnosed years after the breast implant was placed. The earliest report was one year after implant placement and the latest was 23 years after the implant surgery. About half the cases occurred within the first 7 years after implant. BIA-ALCL was most often diagnosed in women who had textured implants. The textured implant may have been placed at the most recent surgery or at any other prior breast implant operation |
| If you develop swelling or pain around your breast implants, be sure to talk to your health care provider. Your health care provider should consider the possibility of BIA-ALCL if, after you have recovered from your breast implant operation, you later notice changes in the way your breast looks or feels—including swelling or pain around the implant. If your health care provider suspects BIA-ALCL, they will refer you to an appropriate specialist for evaluation which may involve obtaining fluid and some tissue samples from around your breast implant. If a diagnosis of BIA-ALCL is confirmed, the doctor will develop an individualized treatment plan for you. Because of the small number of cases worldwide and the variety of available treatment options, there is no single defined treatment. However, if you are diagnosed with BIA-ALCL, the National Comprehensive Cancer Network (NCCN) recommends removing the implant and the surrounding tissue |
| If you have breast implants you should monitor them and follow your routine medical care. You do not need to take any additional steps. It is not necessary to remove your breast implants if you have no symptoms without a diagnosis of BIA-ALCL |
| If you are diagnosed with BIA-ALCL, you can help the FDA understand the disease and effectiveness of treatment. You or your doctor should report all confirmed cases of BIA-ALCL to the FDA (https://www.fda.gov/Safety/MedWatch/). In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential |
| In addition, if you are diagnosed with BIA-ALCL, talk to your doctor about reporting it to the PROFILE Registry (https://www.thepsf.org/research/clinical-impact/profile.htm). Every case of BIA-ALCL should be reported to the PROFILE Registry because this helps provide a better understanding of the disease |
| If you are considering breast implant surgery, you should discuss the risks and benefits with your health care provider. You may also visit the FDA’s Breast Implants website for additional information https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm |
| For additional information on FDA’s analysis and review of BIA-ALCL, please visit: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm |
*, example is from Allergan Corp (Dublin, Ireland) (53). BIA-ALCL, breast implant-associated anaplastic large cell lymphoma.