The Recall Desk
CriticalFDA (Devices)·Z-2452-2019·Announced 2019-09-18

Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

Allergan is recalling 4 million textured breast implants worldwide after FDA safety updates linked them to a higher incidence of anaplastic large cell lymphoma.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric, and the hazard involves a cancer diagnosis (BIA-ALCL).

Plain-English summary

Allergan PLC is recalling approximately 4,026,287 Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants and tissue expanders. The recall covers specific style numbers including LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, and FX, which may have been sold under the McGhan, Inamed, or NATRELLE brands. These products were distributed worldwide and across all 50 US states, the US Virgin Islands, and Puerto Rico.

The recall was initiated following notification by 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. The affected products are indicated for breast augmentation and breast reconstruction.

Patients who have received these implants should consult with their healthcare provider to discuss the potential risks and appropriate follow-up care. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death.

The recalled product

Product
Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM
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 LL: LL-410135/10888628003170
  • LL-410180/10888628003187
  • LL-410210/10888628003194
  • LL-410240/10888628003200
  • LL-410300/10888628003217
  • Style LM: LM-410140/10888628003224
  • LM-410190/10888628003231
  • LM-410220/10888628003248
  • LM-410250/10888628003255
  • LM-410320/10888628003262
  • Style LF: LF-410125/10888628003057
  • LF-410150/10888628003064
  • LF-410175/10888628003071
  • LF-410205/10888628003088
  • LF-410240/10888628003095
  • LF-410270/10888628003101
  • LF-410310/10888628003118
  • LF-410390/10888628003125
  • LF-410440/10888628003132
  • LF-410490/10888628003149

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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