Breast Implant Recall: What You Need to Know

Editor's note: This story provides updated information on a news story first published on July 25, 2019.

In 2019, the pharmaceutical company Allergan recalled all Biocell textured breast implants at the request of the US Food and Drug Administration (FDA).  Evidence demonstrated that this type of implant is linked to a rare type of lymphoma:  breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

In announcing the recall, the FDA also issued a safety communication for patients and health care providers about the recalled implants that include:  

• Natrelle Saline-Filled Breast Implants
• Natrelle Silicone-Filled Breast Implants
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

The safety communication also included a recall on certain types of tissue expanders. These are balloon-like sacs that are slowly expanded with salt-water (saline) to stretch the skin so the permanent implant can be inserted later. The tissue expander recall includes:

• Natrelle 133 Plus Tissue Expander
• Natrelle 133 Tissue Expander with Suture Tabs

The risks associated with these breast implants

The FDA first reported a possible link between breast implants and ALCL in 2011. More evidence  from patient registries strengthened the FDA’s understanding of this link, leading to the recall. Importantly, this type of lymphoma occurs more often in women who have implants with textured surfaces compared with smooth surfaces. The risk is also higher for those with Allergan Biocell implants than those with other types of textured implants. More research is needed about if the type of filling used has any impact on the risk for lymphoma.

At the time of the recall, the FDA stated that 573 unique BIA-ALCL cases had been identified globally; 481 of those cases, or 84%, were linked to Allergan textured implants. Based on their analyses, the FDA determined that the risk of BIA-ALCL from an Allergan implant was about six times greater than the risk attributed to implants from other manufacturers. 

The overall risk of BIA-ALCL is still low. However, the number of people diagnosed with and dying from BIA-ALCL continues to increase, and the link between the disease and Allergen products continues to be shown.  As of 2023, the FDA has reported the following data about BIA-ALCL:

• 1264 cases worldwide; 552 (44%) of those cases from the US
• 63 deaths worldwide; 16 (25%) of those deaths from the US
• Of global cases
  • 918 (73%) had textured implants
  • 1079 (85%) had implants manufactured by Allergan

What to do if you have implants

The recall does not impact everyone with breast implants. The FDA recommends the following if you do have breast implants:

• Talk to your health care provider about your risk of BIA-ALCL.
• Keep records of your implant’s manufacturer and model name.
• Continue your regular, routine medical care and follow-up. If you notice any changes in your breasts or have concerns, contact your health care provider.
• If you have recalled implants, you do not need to have them removed unless you are having symptoms such as lumps, pain, swelling, or asymmetry (breasts that look different from each other).

The FDA advises women thinking about breast implants to talk with their health care providers about the benefits and risks of implants. Your health care provider can also explain the FDA’s current safety requirements for approved breast implants.