The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2455-2019·Announced 2019-09-18

Allergan Recalls Natrelle Textured Breast Implants and Tissue Expanders

Allergan PLC is recalling Natrelle 133 tissue expanders due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured breast implants.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 by the agency. The hazard involves a known serious health consequence (anaplastic large cell lymphoma) associated with the product, which aligns with criteria for Severe severity due to the potential for serious injury or death.

Plain-English summary

The U.S. Food and Drug Administration has notified Allergan PLC regarding global safety information concerning a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have received textured breast implants. In response to this notification, Allergan is initiating a recall of specific Natrelle 133 Tissue Expanders.

The products affected include the Natrelle 133 Tissue Expanders, also known as style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander. These are sterile devices intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline. The recall covers products sold under the McGhan, Inamed, or NATRELLE brands.

The affected units include style numbers 133FV, 133MV, 133LV, 133FX, 133MX, 133SX, and 133SV with various lot codes. The total quantity of breast implants and tissue expanders involved in this action is 4,026,287 units. These products were distributed worldwide, including all fifty U.S. states, the U.S. Virgin Islands, Puerto Rico, and several international locations such as Canada, Japan, and Korea.

Consumers who have received these implants or tissue expanders should consult their healthcare provider for guidance on monitoring and potential next steps.

The recalled product

Product
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11…
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implants and Tissue Expanders
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 133FV: 133FV-11 10888628003927
  • 133FV-12 10888628003934
  • 133FV-13 10888628003941
  • 133FV-14 10888628003958
  • 133FV-15 10888628003965
  • 133FV-16 10888628003972
  • STYLE 133MV: 133MV-11 10888628004108
  • 133MV-12 10888628004115
  • 133MV-13 10888628004122
  • 133MV-14 10888628004139
  • 133MV-15 10888628004146
  • 133MV-16 10888628004153
  • STYLE 133LV: 133LV-11 10888628004047
  • 133LV-12 10888628004054
  • 133LV-13 10888628004061
  • 133LV-14 10888628004078
  • 133LV-15 10888628004085
  • 133LV-16 10888628004092
  • STYLE 133FX: 133FX-11 10888628003989
  • 133FX-12 10888628003996

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 · lymphoma

See all →

Similar recalls