On July 24, 2019, the FDA issued a safety communication requesting Allergan to voluntarily recall certain breast implants and tissue expanders to protect patients from risks associated with certain textured breast implants. The macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold in the U.S.; textured implants account for only 10% of all breast implants sold in the U.S.
The FDA’s Safety Communication stated, in part: “To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. 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 will recall its BIOCELL textured breast implants and tissue expanders from the global market. These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan.”
The FDA reported a new worldwide total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.
What Is BIA-ALCL?
BIA-ALCL is not breast cancer but a type of non-Hodgkin’s lymphoma (cancer of the immune system). The symptoms of BIA-ALCL are primarily persistent swelling or pain near the breast implant. 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. 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.
The FDA stated: “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 marketing in the U.S. and continued distribution of Allergan’s Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
The FDA advised: “Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants.”
The FDA is not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL in patients with no symptoms (“we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL”). Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. Patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone. Most cases of BIA-ALCL occur many years after breast implant placement.
If you or a loved one have a textured breast implant, especially if it is a BIOCELL textured implant manufactured by Allergan, you should promptly contact us by clicking on this link or by calling us toll-free in the United States at 800-295-3959, to find breast implant lawyers who may answer your questions and represent you in a claim, if appropriate.
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