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Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-13-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133FX With Sut Tab, 550cc. · Class U · Implant

All models of Natrelle Breast Implants (1167) · Natrelle Style 133 Tissue Expanders with Suture Tabs (42)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
1

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628004306), received between Aug 30, 2017 and Jan 17, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jul 24, 2019Class IOpen, 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-2457-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Break2
  • Fluid/Blood Leak2
  • Adverse Event Without Identified Device or Use Problem1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Failure of Implant2
  • No Known Impact Or Consequence To Patient2
  • Cellulitis1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿INFECTION¿ AND THE TISSUE EXPANDER REMAINED IMPLANTED FOR GREATER THAN SIX MONTHS. DEVICE HAS BEEN EXPLANTED.

    Patient problems: Cellulitis; Unspecified Infection

    MAUDE report 9601099 ↗
  • InjuryJan 16, 2019Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

    PATIENT REPORTED A LEFT SIDE DEFLATION AND PAIN. TISSUE EXPANDER WAS IMPLANTED FOR MORE THAN 6 MONTHS. DEVICE REMAINS IMPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8253752 ↗
  • InjuryJun 23, 2018Break; Break

    HEALTHCARE PROFESSIONAL REPORTED A "A HOLE" ON THE TISSUE EXPANDER AND WAS NOT IMPLANTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7632505 ↗
  • InjuryJan 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL CONFIRMED ISSUE AS A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 7205856 ↗
  • MalfunctionAug 30, 2017Break; Break

    HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER WAS LEAKING" DURING IMPLANTATION SURGERY. PATIENT CONTACT WITH THE DEVICE DID OCCUR. SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6829699 ↗

Other Expander, Skin, Inflatable devices

All Expander, Skin, Inflatable devices →

Sources and updates

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