Allergan recalls specific silicone breast implants due to increased risk of BIA-ALCL, a rare lymphoma. Affected implants include Natrelle, McGhan, TruForm 2, BIOCELL, and Styles 110/120. No remedy details provided in recall notice.
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 certain breast implants because they may cause a rare type of lymphoma called BIA-ALCL. This recall affects 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 lymphoma called BIA-ALCL. This condition occurs in a small number of patients with textured implants, particularly those who have had implants for longer periods.
Women who received Natrelle, McGhan, TruForm 2, BIOCELL, or Styles 110/120 implants for breast augmentation or reconstruction are affected. Those with textured implants are at higher risk due to the BIA-ALCL link.
Check if your implant is labeled as Natrelle, McGhan, TruForm 2 (Soft Touch), BIOCELL, or Styles 110 or 120 Soft Touch. These implants were sold globally but not distributed in the United States.
Identify if your implant matches the recalled types: Natrelle, McGhan, TruForm 2 (Soft Touch), BIOCELL, or Styles 110/120 Soft Touch.
The recall notice does not specify a remedy, so the official information does not address whether to continue using the implants.
The recall was initiated after the FDA updated global safety information about a higher incidence of BIA-ALCL in patients with textured breast implants.
No, the recall states these implants were not distributed within the US.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2462-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2462-2019 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.
