Introduction
According to the National Library of Medicine, breast implant-associated in anaplastic lymphoma kinase negative large cell lymphoma is related to increased risks of BIA-ALCL.[1]
Data
On average, somewhere between 200,000 and 290,000 women in the United States have breast augmentation surgery annually. Some manufacturers of textured implant companies like Allergan, Johnson & Johnson, and Sientra, have been sued in both state and federal court due to the increased risk of BIA-ALCL. In 2019, according to the FDA, at least 457 women were diagnosed with the disease.[2] By 2020, the FDA reported a total of about 733 United States in global medical device reports of the breast implant-associated ALCL.[3]
Injury Criteria
Here at the Michael Brady Lynch Firm, we represent women who have received textured breast implants and have subsequently been diagnosed with BIA-ALCL. It has also been reported in women receiving smooth breast implants but has not had definitive data on the extent of the textured breast implants. Therefore, the current injury criteria is mainly pertaining to the textured breast implants of Allergan, J&J, and Sientra.
Recall
In 2019, the FDA announced a voluntary recall for all Allergan textured breast implants do you to the association between a LCL and the implant itself. It stated that the risk of BIA – ALCL is six times greater than those of a different type of breast implant, “Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”[4]
The Michael Brady Lynch Firm
If you or a loved one have suffered BIA-ALCL due to a textured breast implant, please give us a call at 888-585-5970.
Date: April 11, 2022
Author: Brandon Salter
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5595388/
[2] https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
[3] https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
[4] https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue