Allergan recalls textured breast implants due to higher risk of anaplastic large cell lymphoma (BIA-ALCL). Affected implants include RITZ PRINCESS, BIOCELL, INTRASHIEL, and BioDIMENSIONAL styles RML/RMM/RFL/RFM.
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 textured breast implants because they may increase the risk of a rare type of lymphoma called BIA-ALCL. This recall affects implants used for breast augmentation or reconstruction that were sold internationally but not in the U.S.
Textured breast implants can sometimes cause a rare type of lymphoma called BIA-ALCL. This condition is linked to the textured surface of the implants and may develop years after implantation. The risk is higher for textured implants compared to smooth ones.
Women who have textured breast implants made by Allergan, specifically RITZ PRINCESS, BIOCELL, INTRASHIEL, or BioDIMENSIONAL styles RML, RMM, RFL, and RFM. Those who had these implants for breast augmentation or reconstruction are most at risk.
Check if your implant is labeled as RITZ PRINCESS, BIOCELL, INTRASHIEL, or BioDIMENSIONAL with styles RML, RMM, RFL, or RFM. These implants were used for breast augmentation or reconstruction and were distributed internationally but not in the U.S.
Identify if your implant matches the recalled types: RITZ PRINCESS, BIOCELL, INTRASHIEL, or BioDIMENSIONAL styles RML, RMM, RFL, RFM.
Reach out to your surgeon or implant specialist to discuss removal options and next steps.
The recall does not require immediate removal, but affected women should consult their surgeon about the risk of BIA-ALCL and potential removal options.
The U.S. FDA updated safety information about a higher incidence of BIA-ALCL in patients with textured breast implants.
No, these implants were distributed internationally but not within the United States.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2464-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2464-2019 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.