Allergan recalls Natrelle 133 tissue expanders due to higher risk of anaplastic large cell lymphoma (BIA-ALCL) in some patients. Affected models include specific style numbers and UDI codes.
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 Natrelle 133 tissue expanders because they may cause a rare type of lymphoma called BIA-ALCL. This risk is higher in textured implants and requires immediate action to prevent health issues.
These textured tissue expanders can develop a rare lymphoma (BIA-ALCL) in some patients after implantation. The risk is higher than smooth implants and may require removal of the implant to prevent serious health complications.
Women who have textured breast implants made by Allergan, including Natrelle 133 models with specific style numbers and UDI codes. Those with a history of breast implants are most at risk.
Check for Natrelle 133 tissue expanders with style numbers like 133FV-11 through 133SV-16 and corresponding UDI codes listed in the recall notice. Products may be sold under the McGhan, Inamed, or NATRELLE brands.
Immediately discontinue use of the recalled Natrelle 133 tissue expanders if you have them.
Consult your physician to discuss the recall and potential next steps for your specific implant.
The U.S. FDA identified a higher risk of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured breast implants like these Natrelle 133 models.
Affected models include Natrelle 133 tissue expanders with style numbers 133FV-11 through 133SV-16 and specific UDI codes listed in the recall notice.
The recall requires you to stop using the product and consult your doctor, but removal may be necessary depending on your situation.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2455-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2455-2019 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.
