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Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-11-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133MX With Sut Tab, 300cc. · 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
4
Deaths reported
0
Injuries reported
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628004467), received between May 11, 2018 and Jan 7, 2022 — classified as 3 injuries, 1 malfunction.

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

  • Fluid/Blood Leak2
  • Device Appears to Trigger Rejection1
  • Flaked1

Patient problems

  • Failure of Implant3
  • Capsular Contracture1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "WHITE BLOOD CELL COUNTS LOWER THAN NORMAL." THE DEVICE HAS BEEN EXCHANGED.

    Patient problems: Capsular Contracture

    MAUDE report 13193470 ↗
  • InjuryMar 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "RUPTURE" WITH A TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8410677 ↗
  • InjuryOct 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "RUPTURED" TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 7957158 ↗
  • MalfunctionMay 11, 2018Flaked; Flaked

    HEALTHCARE PROFESSIONAL REPORTED A TISSUE EXPANDER'S "OUTER SHELL WAS FLAKING OFF". SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE.

    Patient problems: Failure of Implant

    MAUDE report 7506532 ↗

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