The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). The products included in the recall are:
The recall also includes tissue expanders. These are balloon-like sacs that are slowly expanded with salt-water to stretch the skin so the permanent implant can be inserted later. They include:
The recall does not mean all women with these implants should have them removed. The FDA says the surgery is not worth the risk unless a woman is having symptoms. Signs and symptoms of BIA-ALCL may include lumps, pain, swelling, and asymmetry (breasts look different from each other).
The FDA first reported a possible link between breast implants and anaplastic large cell lymphoma in 2011. Evidence showed this rare type of lymphoma occurs more often in women who have implants with textured surfaces compared with smooth surfaces.
Since then, more evidence has strengthened the FDA’s understanding of this link. In announcing the recall, the FDA stated that the overall incidence of BIA-ALCL appears to be low, but the risk is greater than previously thought. The risk appears to be more closely linked with Allergan BioCell implants than with other types of textured implants.
The FDA advises women considering breast implants to talk with their health care team about the benefits and risks of textured-surface vs. smooth-surface implants.
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