Allergan BIOCELL® textured breast implants and tissue expanders have been recalled worldwide due to an uncommon incidence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare cancer of the immune system. On July 25, 2019, the U.S. Food and Drug Administration (FDA) issued a nationwide recall due to an increasing number of cases and deaths from the Allergan BIOCELL® implant associated with this type of cancer. At least 573 cases and 33 deaths have been reported worldwide, with 481 of the cases clearly attributed to the Allergan Breast implants. Of the 33 deaths, the type of breast implant was known in 13 cases, and in 12 of those cases, the maker was Allergan.
The worldwide recall includes the following Allergan BIOCELL® products:
- Natrelle Saline-Filled breast implants,
- Natrelle Silicone-Filled breast implants,
- Natrelle Inspira Silicone-Filled breast implants, and
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including:
- Natrelle 133 Plus Tissue Expander and
- Natrelle 133 Tissue Expander with Suture Tabs
Based on the current information available to the FDA, the risk of developing BIA-ALCL with Allergan BIOCELL® Natrelle textured breast implants is approximately six (6) times greater than with other textured implants marketed in the U.S.
What is Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)?
BIA-ALCL is a type of non-Hodgkin’s lymphoma, it is not breast cancer. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but it can spread throughout the body. According to the FDA, the overall incidence of developing BIA-ALCL is considered to be low at this time; however, if not diagnosed early or promptly treated, it can spread to lymph nodes and lead to death. BIA-ALCL can be treated successfully with surgery to remove the implant and the scar tissue surrounding the implant in most cases; however, some patients may require treatment with chemotherapy and/or radiation therapy.
What Can I Do If I Have Allergan BIOCELL® Breast Implants?
Most cases of BIA-ALCL occur many years after breast implant placement. If you have any type of Allergan BIOCELL® implant and are experiencing any of the following symptoms, it is recommended that you contact your health care provider regarding the need for further evaluation:
- Pain and tenderness near breast implant
- Swelling near breast implants
- Change in the size or shape of the breast or breasts
- Redness or unexplained skin irritation
The main symptoms of BIA-ALCL are usually swelling and fluid accumulation around
the breast implant. If those symptoms occur, the fluid should be drained and tested for the cancer. Currently, surgery to remove Allergan BIOCELL® implants is not required if you are not experiencing any symptoms, but a follow-up with a medical professional is highly advised to ensure your safety.
If you are affected by the Allergan BIOCELL® breast implant recall, it is advisable to contact a personal injury attorney to evaluate any and all potential claims you may have against Allergan for its defective and potentially fatal products. The attorneys at Panish | Shea | Ravipudi LLP are currently evaluating potential product liability claims against Allergan on behalf of breast implant recipients who may be affected by this recall.
If you have Allergan BIOCELL® textured implants or tissue expanders and have developed BIA-ALCL or other complications, contact our experienced product liability lawyers at (877) 800-1700 for a free consultation to immediately discuss your case.