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Following a U.S. Food and Drug Administration request, Allergen recalled its BIOCELL textured breast implants and tissue expanders. The recall is classified by the FDA as Class I, the most serious type of recall. The FDA has requested the recall due to risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system that can develop in the scar tissue and fluid surrounding breast implants. An FDA analysis concluded the risks of BIA-ALCL with Allergan BIOCELL implants to be 6 times higher than that of textured implants from other manufacturers.
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