The Recall Desk
SevereFDA (Devices)·Z-2465-2019·Announced 2019-09-18

Allergan Textured Breast Implants Recalled Due to Lymphoma Risk

Allergan is recalling textured breast implants worldwide due to an increased risk of anaplastic large cell lymphoma (BIA-ALCL). Patients should consult their healthcare providers.

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 involves a medical device associated with a serious health condition (anaplastic large cell lymphoma), which aligns with the 'Severe' criteria for significant injury or serious health risks, despite the agency's Class I classification.

Plain-English summary

Allergan PLC is recalling Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, and BioDIMENSIONAL Breast Implants (Styles 150 FH and 150 SH). These textured breast implants and tissue expanders were used for breast augmentation and reconstruction. The recall involves 4,026,287 units distributed worldwide, including all 50 US states, the US Virgin Islands, Puerto Rico, and several international locations.

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. This condition is a rare type of non-Hodgkin lymphoma that can develop in the fluid or scar tissue around the implant.

Patients who have received these specific textured implants should contact their healthcare providers to discuss their individual risks and options. The source text does not specify a deadline for action or a specific remedy beyond medical consultation.

The recalled product

Product
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. 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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