The Food and Drug Administration (FDA) has requested the recall of Allergan’s Biocell textured breast implants and tissue expanders as a result of the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with these devices.
BIA-ALCL is a type of non-Hodgkin’s lymphoma which is found in the scar tissue and fluid near the implant in most cases, although it can spread throughout the body. Typically, the indication is treated with surgery which removes the implant and scar tissue, although in some cases chemotherapy or radiation may be necessary.
This decision follows the newly submitted Medical Device Reports (MDRs) which identified cases across the world where 33 patient deaths were linked to these devices.
The analysis by the FDA found that the risk of BIA-ALCL with textured implants from Allergan was six times more likely compared to other manufacturers in the United States. However, research will continue to determine if the risk of developing BIA-ALCL is limited to specific models of textured implants or all textured breast implants.
The current advice from the FDA is to inform all people who are considering a breast implant of the risk of developing BIA-ALCL.
All affected products are listed on the FDA website, alongside recommendations for both healthcare providers and those with the implants.