Allergan recalls Natrelle 133 Plus tissue expanders with textured surfaces due to higher risk of anaplastic large cell lymphoma (BIA-ALCL) in some patients. Learn which models are affected and what to do.
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 Natrelle 133 Plus tissue expanders because they have a textured surface that may increase the risk of a rare type of lymphoma called BIA-ALCL. This recall affects specific model numbers and styles sold under brands like NATRELLE, McGhan, or Inamed.
Textured surfaces on these implants can cause the body to form a fluid-filled sac around the implant. This sac may then become a site for rare lymphoma cells to grow, specifically anaplastic large cell lymphoma (BIA-ALCL).
Women who have received a textured Natrelle 133 Plus tissue expander implant, particularly those who have had the implant for more than a year. Those with a history of breast cancer or other conditions that affect the immune system may be at higher risk.
Check if your implant is labeled with a style number starting with 133P (e.g., 133P-FV, 133P-MV) and a suffix like -FV, -MV, -LV, -FX, -MX, -SX, or -SV. These products may have been sold under the brands NATRELLE, McGhan, or Inamed.
Look for style numbers starting with 133P followed by a suffix (e.g., 133P-FV, 133P-MV) on your implant's packaging or label.
If you have the recalled implant, contact Allergan directly to discuss your options for removal or replacement.
BIA-ALCL is a rare type of lymphoma that has been linked to textured breast implants. It occurs in a small number of patients with these implants.
Allergan recommends consulting with your doctor to determine if removal is necessary, as the risk varies based on individual health factors.
No, only specific textured Natrelle 133 Plus tissue expanders with style numbers starting with 133P are affected.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2456-2019 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.
