BIA-ALCL and Breast Implant Safety Update
As a Board-Certified Plastic Surgeon, Dr. Sarah Mess always prioritizes patient safety. You may have heard that the FDA recently recalled certain types of breast implants due to an illness called breast implant-associated anaplastic large cell lymphoma, commonly known as BIA-ALCL. We know that you may be concerned if you have breast implants or you are considering breast augmentation, so we want to provide information to answer frequently asked questions about BIA-ALCL and Textured Breast Implants.
What is BIA-ALCL?
Although BIA-ALCL affects the breasts, it is not breast cancer but rather a type of non-Hodgkin’s lymphoma that is associated almost exclusively with certain types of textured breast implants. BIA-ALCL is very rare and highly-treatable, but it can spread throughout the body and have serious consequences if not treated.1 BIA-ALCL symptoms include persistent swelling or pain in the breast, a lump in the breast or armpit, and a hardening of the breast.2
Should I Be Worried About BIA-ALCL If I have Breast Implants?
Understanding the different types of breast implants can help you better understand BIA-ALCL risks. Breast implants are filled with either saline or silicone and the outer shell of an implant can be smooth or textured. The vast majority of implants used in the U.S. are smooth implants, and currently no cases of BIA-ALCL have been reported in conjunction with smooth breast implants.2 The confirmed BIA-ALCL cases are currently all associated with textured implants, which make up a little less than 10% of implants in the United States. Textured implants are more common in Europe and other regions outside the United States. Worldwide, there have been 573 cases of BIA-ALCL, and estimates of the lifetime risk of developing BIA-ALCL are extremely low.3
FDA Recall of Specific Textured Breast Implants
The breast implants that were subject to a voluntary recall were textured-shell implants manufactured by Allergan. Textured implants manufactured by Sientra and Mentor were not included in the recall. Allergan textured implants have been removed from the market. These include:
- Textured Natrelle Saline-Filled breast implants
- Textured Natrelle Silicone-Filled breast implants
- Textured Natrelle Inspira Silicone-Filled breast implants
- Textured Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
For more information on the recall, you can read the full FDA statement here.
What Should I Do If I Have Recalled Implants Or If I Don’t Know What Type Of Implants I Have?
You should monitor your health and see your doctor on a regular basis as part of your self-care routine regardless of implant type or texture. If you do have implants that were recalled, the FDA does not recommend preemptive implant removal, but you can talk to a surgeon about your options. If you are diagnosed with BIA-ALCL, an en bloc implant removal surgery is recommended as part of your treatment. If you experience any symptoms of BIA-ALCL, you should see a physician right away. Your doctor may use an MRI or an ultrasound to evaluate the area around your breast implant and may also use a biopsy. Biopsies for suspected BIA-ALCL should involve CD30 immune staining (CD30IHC) pathology testing in order to accurately rule out BIA-ALCL.
Questions About Breast Implants and Your Health?
Dr. Mess cares about your well-being and also wants to make sure that you stay informed about your health. You can learn more about BIA-ALCL from this informative FAQ from The American Society of Plastic Surgeons. Please contact us if you have any questions about your breast implants, breast augmentation safety, or BIA-ALCL.
1 U.S. Food and Drug Administration. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Available: https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl Accessed December 5, 2019
2 American Society of Plastic Surgeons. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Available: https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary Accessed December 5, 2019
3 American Society of Plastic Surgeons. BIA-ALCL Resources. Available: https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers Accessed December 5, 2019