The Recall Desk
SevereFDA (Devices)·Z-2456-2019·Announced 2019-09-18

Allergan Recalls Natrelle Tissue Expanders Due to Lymphoma Risk

Allergan is recalling Natrelle tissue expanders because the FDA identified a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe). Additionally, the hazard involves a known cancer (BIA-ALCL), which constitutes a significant injury risk.

Plain-English summary

Allergan PLC is recalling Natrelle 133 Plus Tissue Expanders, including various styles with and without suture tabs, as well as associated 21G Needle Infusion Sets. These sterile medical devices are intended for temporary subcutaneous implantation and require periodic inflation with sterile saline. The recall covers 4,026,287 breast implants and tissue expanders combined, distributed worldwide and across all 50 US states, the US Virgin Islands, and Puerto Rico.

The recall was initiated following notification from the U.S. Food and Drug Administration regarding updated global safety information. The FDA identified a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. This safety concern applies to the textured surface of the recalled tissue expanders.

Patients who have received these tissue expanders should consult their healthcare provider for guidance on monitoring and potential removal. The recall includes specific style numbers and UDI codes listed in the official FDA notice Z-2456-2019.

The recalled product

Product
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-F
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implant / Tissue Expander
Hazard
Affected units
4,026,287

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ALL LOTS
  • Product Code/UDI STYLE 133P-FV:133P-FV-11 10888628009646
  • 133P-FV-11-T 10888628009653
  • 133P-FV-12 10888628009660
  • 133P-FV-12-T 10888628009677
  • 133P-FV-13 10888628009684
  • 133P-FV-13-T 10888628009691
  • 133P-FV-14 10888628009707
  • 133P-FV-14-T 10888628009714
  • 133P-FV-15 10888628009721
  • 133P-FV-15-T 10888628009738
  • 133P-FV-16 10888628009745
  • STYLE 133P-MV: 133P-MV-11 10888628010000
  • 133P-MV-12 10888628010024
  • 133P-MV-13 10888628010048
  • 133P-MV-14 10888628010062
  • 133P-MV-15 10888628010086
  • 133P-MV-16 10888628010109
  • STYLE 133P-LV: 133P-LV-11 10888628009882
  • 133P-LV-12 10888628009905

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 15 recalled by Allergan PLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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