The FDA requested that Allergan recall its BIOCELL® textured breast implants and tissue expanders due to increased risk of a rare cancer known as breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma (cancer of the immune system) that can develop in the scar tissue capsule and fluid surrounding a breast implant. In some cases, it can spread throughout the body.
BIA-ALCL is curable in most patients if it’s diagnosed early and treated appropriately, but a small number have died from the illness.
BIA-ALCL is not breast cancer. It can occur around saline-filled or silicone gel-filled implants that have been placed for breast reconstruction after mastectomy or cosmetic breast enlargement. BIA-ALCL seems to only develop in women who have implants with a textured surface (shell) or had them in the past.
The U.S. Food and Drug Association (FDA) reported in July 2019 that 573 women had at that time been diagnosed with BIA-ALCL, and 33 women had died from the disease worldwide. Of the 573 cases, 481 are attributed to textured implants manufactured by Allergan. Of the 33 deaths, the implant maker was known for 13 women. Of these 13 women, 12 were confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis. To date, there are no confirmed reports of BIA-ALCL in women who only ever had smooth implants.
An FDA 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
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046.
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:
Natrelle 133 Plus Tissue Expander (K143354)Natrelle 133 Tissue Expander with Suture Tabs (K102806)