FDA Requests Recall of Allergan Breast Implants
Breast Implant-Associated Anaplastic Large Cell Lymphoma Linked to Allergan BIOCELL Textured Implants
In its commitment to ensuring the post-market safety of medical devices, the FDA used their authority to request that manufacturer Allergan voluntarily recall their BIOCELL textured breast implants and certain tissue expanders from the market over concerns of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
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 is in the process of recalling its BIOCELL textured breast implants and tissue expanders from the global market.
The FDA is not recommending removal of these or other types of breast implants in patients who have no symptoms, due to the low risk of developing BIA-ALCL. Rather, the FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. The FDA will also continue to update the public about developments in this area.
What is 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.
BIA-ALCL Possible Injuries & Side Effects
- Non-Hodgkin’s lymphoma
- Breast enlargement
- Lumps in the breast or armpit
- Breast asymmetry or changes in appearance
Have you been implanted with an Allergan textured breast implant?
Our attorneys are investigating patient claims related to the implantation of these textured breast implants. If you or a loved one has received an Allergan BIOCELL breast implant and have experienced complications or adverse reactions, contact the defective medical device attorneys at Aylstock, Witkin, Kreis & Overholtz today for a free consultation. There is never a fee unless we recover for you.