Allergan BIOCELL® Breast Implants Recalled Worldwide Following Link to Rare Cancer
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 BIOCELL® implants. Of the 33 deaths, the type of 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® textured 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 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® 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 & Boyle 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 develooped BIA-ALCL, contact our experienced product liability lawyers at (877) 800-1700 for a free consultation to immediately discuss your case.