In late July of 2019, Allergan issued a voluntary recall for their BIOCELL textured implants after receiving a notification from the FDA. While these implants are not often used in breast augmentation in the USA, they have been discovered to have a higher risk for causing BIA-ALCL (breast implant-associated anaplastic large cell lymphoma), a rare form of immune system cancer.
Which Allergan implants have been recalled?
Allergan, the makers of BIOCELL implants, have recalled their line of textured silicone and saline implants and tissue expanders, including the following:
- 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
- Natrelle 133 Tissue Expander with Suture Tabs
The recall is not associated with any Natrelle implants with smooth shells that are most commonly used.
What are textured implants?
Textured implants are silicone or saline implants with a rough or grainy surface, rather than the typical smooth implant surfaces. Macro-textured implants, such as those recalled by Allergan, are those textured implants with a more irregular surface than other textured implants.
Textured implants are not frequently used in breast augmentation, making up only 10% of the implants used in the United States. Macro-textured implants, such as Allergan’s BIOCELL implants, are even less common, at only 5% of implants.
Why have Allergan textured implants been recalled?
Allergan’s macro-textured BIOCELL implants were recalled due to an increased risk of BIA-ALCL with this specific brand of implants. Even so, the risk of developing the disease is very low.
While the cause is unknown, one theory is that the macro-textured implants increase the risk of developing BIA-ALCL as a result of the rough texture. The bumps and crevices that help these types of implants better adhere to the surrounding tissue to reduce the possibility of rotation may create an environment where bacteria can flourish, a possible precursor to BIA-ALCL.
What is BIA-ALCL?
BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, is a rare non-Hodgkin’s type of lymphoma with only 288 cases reported in the United States since 1996. Symptoms may include persistent pain, swelling, fluid retention in the breasts, a lump in the breast or armpit, and asymmetry of the breasts. BIA-ALCL grows slowly, making it easy to catch as well as easy to treat. Treatment is simple and includes the removal of the implant and surrounding scar tissue.
Do I need to worry about the Allergan implant recall?
If you currently have the recalled Allergan textured implants and are not experiencing any symptoms of BIA-ALCL, the FDA does not advise having them removed. However, speak with your doctor about any concerns you might have regarding your breast implants. It is advised that you pay close attention to any changes in your breasts and keep an eye out for the symptoms of BIA-ALCL.
How can I protect myself from BIA-ALCL in the future?
While developing BIA-ALCL is highly unlikely, it is smart to take the necessary steps to protect yourself from any breast implant illness. The primary way to protect yourself is to speak with a highly-skilled, board-certified plastic surgeon who can guide you and uses the safest, top-of-the-line implants.
If you are interested in breast augmentation, Dr. Shapiro and his team can consult with you to help you determine the best options. If you are concerned about your current implants and would like to discuss your options for breast implant removal, replacement, or a breast lift, please reach out to schedule your consultation.
Dr. Shapiro is an award-winning, board-certified plastic surgeon with over 26 years of experience, changing the lives of patients across the Scottsdale and Paradise Valley area and beyond.
