Allergan recalls McGhan BioDIMENSIONAL silicone-filled breast implants style 153 due to higher risk of anaplastic large cell lymphoma (BIA-ALCL).
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 McGhan BioDIMENSION: silicone-filled breast implants style 153 used for breast augmentation and reconstruction. This recall is due to a higher risk of a rare type of lymphoma called BIA-ALCL in some patients with textured implants.
The recall was initiated after the FDA identified a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured breast implants. This rare lymphoma can develop years after implant placement and may require surgery to remove the implant.
Women who have received McGhan BioDIMENSIONAL silicone-filled breast implants style 153 for breast augmentation or reconstruction are affected. Those with textured implants are at higher risk for BIA-ALCL.
Check if you have McGhan BioDIMENSIONAL silicone-filled breast implants style 153 used for breast augmentation or reconstruction. All lots of this product are affected.
Talk to your healthcare provider about the recall and possible next steps for your implants.
No, this recall specifically applies to McGhan BioDIMENSIONAL silicone-filled breast implants style 153 used for breast augmentation or reconstruction.
BIA-ALCL is a rare type of lymphoma that has been found in patients with textured breast implants, according to FDA safety updates.
The recall does not require immediate removal; consult your doctor to discuss options based on your specific situation.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2459-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2459-2019 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.
