Breast implants, both saline and silicone gel, are generally considered a safe option for breast augmentation or reconstruction.
Biocell® textured breast implants and tissue expanders, however, were recalled by Allergan (now called AbbVie) on July 24, 2019 as requested by the Food and Drug Administration (FDA).
These products feature a unique textured surface that is associated with an increased risk of a type of non-Hodgkin’s lymphoma (breast implant-associated anaplastic large cell lymphoma – BIA-ALCL), which is a cancer of the immune system. If not treated early, this diagnosis can lead to the need for chemotherapy, radiation therapy, and can even be fatal.
While the FDA considers the probability of developing BIA-ALCL to be low, and does not recommend removal if no symptoms of BIA-ALCL are present, if you or someone you know has this type of implant you should of course consult with your medical provider.
Legal options are also important to consider. At this time Allergan offers a replacement warranty to replace the Biocell® textured implant with a smooth implant, but it does not cover surgical fees, and has a two-year limit from the date of the recall announcement.
Recently, AbbVie received a warning letter from the FDA because of deficiencies in their post approval long term studies of the implant.
If you have a Biocell® breast implant and wish to discuss your options, please contact our office today.