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Natrelle Style 133 Tissue ExpandersRecalls & reported problems across all models

Allergan, Inc. · 42 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 Style 133 Tissue Expanders model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
55
Deaths reported
0
Injuries reported
48
Recalls
1

We found 42 models of Natrelle Style 133 Tissue Expanders by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2017 and Aug 30, 2022 — classified as 48 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 Style 133 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-2455-2019 · Root cause: Unknown/Undetermined by firm · names 42 of these models · Recall details · FDA record ↗

Most reported Natrelle Style 133 Tissue Expanders problems

Device problems

  • Fluid/Blood Leak24
  • Adverse Event Without Identified Device or Use Problem13
  • Break8
  • Detachment of Device or Device Component3
  • Improper or Incorrect Procedure or Method3
  • Patient-Device Incompatibility2
  • Device Handling Problem1
  • Loss of or Failure to Bond1

Patient problems

  • Failure of Implant28
  • Unspecified Infection15
  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient3
  • Capsular Contracture2
  • Cellulitis2
  • No Patient Involvement2
  • Abscess1

Natrelle Style 133 Tissue Expanders models

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

Recent Natrelle Style 133 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