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Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-12-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133MX 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
5
Recalls naming it
1

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888628004474), received between Dec 18, 2017 and Mar 27, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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

  • Fluid/Blood Leak4
  • Break1
  • Device Contamination with Chemical or Other Material1

Patient problems

  • Failure of Implant5
  • 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.

  • MalfunctionMar 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

    PATIENT REPORTED LEFT SIDE "LEAK". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 9891016 ↗
  • InjuryNov 14, 2019Break; Break

    HEALTHCARE PROFESSIONAL REPORTED TO A COMPANY REPRESENTATIVE "METAL BACKING WAS SEPARATED FROM THE SILICONE PORT" OF A TISSUE EXPANDER. AFFECTED SIDE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 9320999 ↗
  • InjuryApr 18, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    HEALTHCARE PROFESSIONAL REPORTED TO COMPANY REPRESENTATIVE A "SMALL BLOND HAIR ON TOP OF THE EXPANDER." PATIENT CONTACT DID NOT OCCUR AND SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 8526883 ↗
  • InjuryMar 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROVIDER REPORTED RIGHT SIDE "EXPANDER, FILLED TO 350- 5 DAYS AFTER SURGERY PATIENT SAID THE EXPANDER STARTED TO LEAK. HE DIDN¿T DO ANY OFFICE FILL." DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8397188 ↗
  • InjuryMar 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION OF A TISSUE EXPANDER. DEVICE WAS EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8386845 ↗
  • InjuryDec 18, 2017Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 7125223 ↗

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