The Recall Desk
CriticalFDA (Devices)·Z-2460-2019·Announced 2019-09-18

Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

Allergan 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

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 severity score of 5 per the rubric.

Plain-English summary

Allergan PLC is recalling Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implants and tissue expanders. The affected styles include LL, LM, LF, ML, MM, MF, FL, FM, and FF. These products were used for breast augmentation and reconstruction.

The recall was initiated after the U.S. Food and Drug Administration (FDA) provided updated global safety information indicating a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured breast implants. The agency classified this recall as Class I.

The recall covers 4,026,287 breast implants and tissue expanders combined. Distribution was worldwide and nationwide in the United States, including all 50 states, the US Virgin Islands, and Puerto Rico. International distribution included Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam. Patients with these implants should contact their healthcare provider for guidance.

The recalled product

Product
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF 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 →

Related recalls

Same manufacturer · Allergan PLC

See all →

Same hazard · anaplastic large cell lymphoma

See all →