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Natrelle 133 Plus Tissue ExpandersRecalls & reported problems across all models

Allergan, Inc. · 84 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names at least one Natrelle 133 Plus Tissue Expanders model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
32
Deaths reported
0
Injuries reported
26
Recalls
1

We found 84 models of Natrelle 133 Plus Tissue Expanders by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2017 and Jan 30, 2023 — classified as 26 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Natrelle 133 Plus Tissue Expanders recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Jul 24, 2019Open, Classified

    The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

    Z-2456-2019 · Root cause: Unknown/Undetermined by firm · names 84 of these models · Recall details · FDA record ↗

Most reported Natrelle 133 Plus Tissue Expanders problems

Device problems

  • Fluid/Blood Leak23
  • Adverse Event Without Identified Device or Use Problem3
  • Break2
  • Device Appears to Trigger Rejection1
  • Device Contamination with Chemical or Other Material1
  • Improper or Incorrect Procedure or Method1
  • Material Perforation1

Patient problems

  • Failure of Implant23
  • No Known Impact Or Consequence To Patient3
  • No Patient Involvement2
  • Unspecified Infection2
  • Capsular Contracture1
  • Cellulitis1

Natrelle 133 Plus Tissue Expanders models

84 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Natrelle 133 Plus Tissue Expanders adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Allergan, Inc. products

All Allergan, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page