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

Allergan, Inc. · NATRELLE 133MV With Sut Tab, 400cc. · 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
6
Deaths reported
0
Injuries reported
4
Recalls naming it
1

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888628004429), received between Dec 20, 2017 and May 1, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Adverse Event Without Identified Device or Use Problem4
  • Break1
  • Unsealed Device Packaging1

Patient problems

  • Necrosis2
  • Unspecified Infection2
  • Failure of Implant1
  • No Patient Involvement1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 10017757 ↗
  • InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TISSUE FAILURE/NECROSIS". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Necrosis

    MAUDE report 9665802 ↗
  • InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTH PROFESSIONAL REPORTED A LEFT SIDE "TISSUE FAILURE/NECROSIS". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Necrosis

    MAUDE report 9647844 ↗
  • MalfunctionJan 24, 2019Unsealed Device Packaging; Unsealed Device Packaging

    HEALTHCARE PROFESSIONAL REPORTED "WHEN THE ITEM WAS OPENED THE TOP LAYER OF THE WHITE COVERING WAS NOT ATTACHED CAUSING THE IMPLANT TO FALL OUT ON THE FLOOR". THE DEVICE WAS NOT IMPLANTED. IT IS UNKNOWN IF SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 8273717 ↗
  • MalfunctionJan 2, 2018Break; Break

    HEALTHCARE PROFESSIONAL REPORTED A "LEAK" WITH A TISSUE EXPANDER. DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACKUP EXPANDER.

    Patient problems: Failure of Implant

    MAUDE report 7157598 ↗
  • InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION." THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 7133465 ↗

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