Allergan recalls McGhan Cro:134 tissue expanders after FDA reports higher risk of BIA-ALCL in patients with textured implants. Affected users should contact for return or repair.
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 McGhan Croissant-Shaped Tissue Expanders (Style 134) because they may cause a rare cancer called BIA-ALCL. This risk is linked to textured implants used in breast procedures.
The tissue expanders may cause a rare cancer called anaplastic large cell lymphoma (BIA-ALCL) in some patients. This risk is higher with textured implants used in breast procedures, as reported by the FDA.
Patients who received McGhan Croissant-Shaped Tissue Expanders (Style 134) for breast procedures are most at risk. The recall affects individuals who used these expanders for temporary subcutaneous implantation.
Check for McGhan Croissant-Shaped Tissue Expanders labeled as Style 134. These were sold for temporary subcutaneous implantation and require periodic saline injections.
Reach out to Allergan to discuss return or repair options for the recalled tissue expanders.
The U.S. FDA reported a higher incidence of BIA-ALCL (a rare cancer) in patients with textured breast implants, prompting this recall.
No, but affected users should contact Allergan for return or repair options as the recall requires caution.
The recalled product is McGhan Croissant-Shaped Tissue Expanders, Style 134.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-2458-2019 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-2458-2019 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.
