The Recall Desk
SevereFDA (Devices)·Z-2454-2019·Announced 2019-09-18

Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

Allergan PLC is recalling specific textured breast implants and tissue expanders due to 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 severity score of at least 4 according to the rubric. Additionally, the hazard involves a known cancer (BIA-ALCL), representing a significant health risk.

Plain-English summary

Allergan PLC is recalling Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, and associated tissue expanders. The recall covers 4,026,287 units in total, including specific style numbers 110, 115, and 120. These products were distributed worldwide and across all 50 US states, the US Virgin Islands, and Puerto Rico.

The recall was initiated following notification by the U.S. FDA regarding 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 affected products may have been sold under the McGhan, Inamed, or NATRELLE brands and were used for breast augmentation and reconstruction.

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

The recalled product

Product
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-
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 STYLE 110:110-090 10888628002159
  • 110-120 10888628002166
  • 110-150 10888628002173
  • 110-180 10888628002180
  • 110-210 10888628002197
  • 110-240 10888628002203
  • 110-270 10888628002210
  • 110-300 10888628002227
  • 110-330 10888628002234
  • 110-360 10888628002241
  • 110-390 10888628002258
  • 110-420 10888628002265
  • 110-450 10888628002272
  • 110-480 10888628002289
  • 110-510 10888628002296
  • STYLE 115:115-150 10888628002302
  • 115-167 10888628002319
  • 115-185 10888628002326
  • 115-203 10888628002333
  • 115-222 10888628002340

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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