Allergan recalls textured breast implants (Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL) linked to rare anaplastic large cell lymphoma. Affected patients should contact for evaluation.
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Allergan is recalling several types of textured breast implants due to a rare risk of anaplastic large cell lymphoma (BIA-:ALCL) found in some patients. This recall applies to implants used for breast augmentation or reconstruction that were sold globally but not distributed in the US.
Textured breast implants have been linked to a rare type of lymphoma called anaplastic large cell lymphoma (BIA-ALCL) in some patients. This condition is uncommon but can occur years after implant placement.
Women who received textured breast implants from Allergan (Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL) for breast augmentation or reconstruction are affected. Those with implants of styles KML, KMM, KLL, KLM are at risk.
Check if your breast implant is textured (rough surface) and matches the listed styles: KML, KMM, KLL, KLM. These implants were used for breast augmentation or reconstruction and sold globally but not in the US.
Reach out to Allergan for evaluation and guidance about your specific implant type.
The recall is due to a rare risk of anaplastic large cell lymphoma (BIA-ALCL) found in some patients with textured implants. Not all implants pose this risk.
No, these implants were not distributed within the US.
Contact Allergan for evaluation and guidance about your specific implant type.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2463-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2463-2019 from Allergan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
