The Recall Desk
HighFDA (Devices)·Z-2451-2019·Announced 2019-09-18

Allergan Recalls Natrelle Textured Breast Implants Due to Lymphoma Risk

Allergan PLC is recalling Natrelle textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) associated with a serious condition (BIA-ALCL) where specific injury or death reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Allergan PLC is recalling approximately 4,026,287 Natrelle saline-filled breast implants and tissue expanders. The affected products include specific styles 163, 168, 363, and 468, which may have been sold under the McGhan, Inamed, or NATRELLE brands. These devices are used for breast augmentation and breast reconstruction.

The recall was initiated following notification from 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 products were distributed worldwide and across all 50 U.S. states, the U.S. Virgin Islands, and Puerto Rico. International distribution included Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam. Patients who have received these implants should consult their healthcare provider regarding the safety information and potential risks associated with textured breast implants.

The recalled product

Product
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,1
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 Product Style 163: 163-360/10888628000704
  • 163-440/10888628000711
  • 163-530/10888628000728
  • 163-655/10888628000735
  • 163-780/10888628000742 Product Style 168: 168-120/10888628000759
  • 168-150/10888628000766
  • 168-180/10888628000773
  • 168-210/10888628000780
  • 168-240/10888628000797
  • 168-270/10888628000803
  • 168-300/10888628000810
  • 168-330/10888628000827
  • 168-360/10888628000834
  • 168-390/10888628000841
  • 168-420/10888628000858
  • 168-450/10888628000865
  • 168-480/10888628000872
  • 168-510/10888628000889
  • 168-550/10888628000896
  • 168-600/10888628000902

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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