The Recall Desk
SevereFDA (Devices)·Z-2453-2019·Announced 2019-09-18

Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

Allergan is recalling textured Natrelle Inspira breast implants and tissue expanders following FDA safety updates linking these devices to a higher incidence of anaplastic large cell lymphoma.

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 Severe (Score 4) because it involves a medical device associated with a serious health condition (anaplastic large cell lymphoma) and a significant injury risk, consistent with the rubric criteria for significant injury reports or high-risk device defects.

Plain-English summary

Allergan PLC is recalling approximately 4 million Natrelle Inspira silicone-filled breast implants and tissue expanders. The recall covers specific textured styles, including TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, and TCX. These products were distributed worldwide and across all 50 US states, the US Virgin Islands, and Puerto Rico.

The action was initiated after the U.S. Food and Drug Administration (FDA) issued updated global safety information. The FDA identified a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. The recall is limited to the textured styles listed in the official notice; smooth implants are not included in this specific recall action.

Patients who have received these specific textured implants should contact their healthcare provider to discuss the safety information and potential next steps. The FDA has not reported specific injury counts or fatalities in this notice, but the association with BIA-ALCL represents a significant health risk.

The recalled product

Product
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-1
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implants
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 TRL: TRL-125 10888628007659
  • TRL-140 10888628007666
  • TRL-170 10888628007673
  • TRL-200 10888628007680
  • TRL-230 10888628007697
  • TRL-260 10888628007703
  • TRL-290 10888628007710
  • TRL-320 10888628007727
  • TRL-350 10888628007734
  • TRL-380 10888628007741
  • TRL-410 10888628007758
  • TRL-460 10888628007765
  • TRL-510 10888628007772
  • TRL-560 10888628007789
  • TRL-610 10888628007796
  • Style TRLP:TRLP-125 10888628007802
  • TRLP-145 10888628007819
  • TRLP-165 10888628007826
  • TRLP-190 10888628007833
  • TRLP-205 10888628007840

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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