Health

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market.

The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found at the end of this communication.

The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.

Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.

The FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. Therefore, at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.

BIA-ALCL is not breast cancer – it is a 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. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.

 

Patients: Important Recommendations If You Have Allergan BIOCELL Breast Implants

  • If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.
  • Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.
  • If you experience any of these symptoms or other changes, talk to your health care provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
  • Based on discussions with your health care provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.
  • As with any implanted device, it is good to keep a record of the device manufacturer, unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
  • Understand that most cases of BIA-ALCL occur many years after breast implant placement. Talk to your surgeon about your risk of developing BIA-ALCL.
  • If you are considering breast implants, please see these important recommendations.

For further details, review the entire FDA Communication here.