Allergan recalls Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implants (styles LL, LM, LF, ML, MM, MF, FL, FM, FF) due to higher risk of rare BIA-ALCL. This recall applies to implants used in breast augmentation or reconstruction outside the US.
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 specific styles of Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implants because of a higher risk of a rare type of lymphoma (BIA-ALCL) in some patients. This recall affects implants used in breast augmentation or reconstruction that were sold outside the United States.
These textured breast implants have been linked to a rare type of lymphoma called BIA-ALCL in some patients. The risk is higher than typical but remains very low, and the implants are not expected to cause serious injury in normal use.
Women who received these specific implant styles for breast augmentation or reconstruction outside the US are most at risk. The recall does not apply to implants used within the United States.
Check if your implant is labeled as Natrelle or McGhan 410 TruForm 2 (Soft Touch) BIOCELL with styles LL, LM, LF, ML, MM, MF, FL, FM, or FF. This recall applies only to implants used outside the United States for breast augmentation or reconstruction.
Reach out to your surgeon or the medical facility where you received the implant to discuss next steps.
The recall is for a rare type of lymphoma (BIA-ALCL) that has been reported in some patients with textured implants, but this is not expected to cause serious injury in normal use.
No, this recall applies only to implants used outside the United States for breast augmentation or reconstruction.
Contact your surgeon or the medical facility where you received the implant to discuss next steps.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2460-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2460-2019 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.
