The Recall Desk
SevereFDA (Devices)·Z-2463-2019·Announced 2019-09-18

Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

Allergan PLC is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

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 mandates a minimum severity score of 4 per the rubric. Additionally, the hazard involves a serious medical condition (anaplastic large cell lymphoma).

Plain-English summary

Allergan PLC is recalling approximately 4,026,287 breast implants and tissue expanders, including the Komuro, Soft Touch, BIOCELL, INTRASHIEL, and BioDIMENSIONAL styles (KML, KMM, KLL, KLM). These products were used for breast augmentation and breast reconstruction. The recall covers distribution in all 50 US states, the US Virgin Islands, Puerto Rico, and several international locations.

The action was initiated following notification by the U.S. FDA of recently updated global safety information. This information indicates a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. The source text does not specify a particular lot number, stating instead that the product was not distributed within the US, which appears to contradict the listed US distribution scope; however, the recall notice explicitly lists US distribution.

Patients who have received these implants should consult their healthcare providers regarding the updated safety information and potential risks associated with BIA-ALCL.

The recalled product

Product
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
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 (1)

  • All Lots: Note:This product was not distributed within the US

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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