Skip to content

Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-16-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133MV With Sut Tab, 700cc. · 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
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628004450), received between Aug 23, 2017 and Sep 13, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 Leak3
  • Use of Device Problem2
  • Delivered as Unsterile Product1
  • Device Appears to Trigger Rejection1

Patient problems

  • Failure of Implant2
  • Capsular Contracture1
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

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

  • InjurySep 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PATIENT REPORTED LEFT SIDE "CLINIC TOLD HER SHE HAS CAPSULAR CONTRACTURE ON THE LEFT IMPLANT." DEVICE REMAINS IMPLANTED.

    Patient problems: Capsular Contracture

    MAUDE report 17737931 ↗
  • MalfunctionJun 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

    COMPANY REPRESENTATIVE REPORTED "RUPTURED" DEVICE, AND HEALTHCARE PROVIDER ADDITIONALLY REPORTED "TISSUE EXPANDER WHICH HAD TORN AT THE JUNCTION OF THE PORT PATCH AND THE FLUID CHAMBER." EXPANSION WAS COMPLETE. DEVICE HAS BEEN EXPLANTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8681002 ↗
  • MalfunctionJan 3, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

    HEALTHCARE PROFESSIONAL REPORTED THE "STERILITY OF A TISSUE EXPANDER WAS COMPROMISED; THE SEAL IS OBVIOUSLY TORN". DEVICE WAS NOT IMPLANTED.

    Patient problems: No Patient Involvement

    MAUDE report 8214043 ↗
  • InjuryAug 23, 2017Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION OF A TISSUE EXPANDER AND THAT THE "MEDIAL TABS WERE TORN". DEVICE WAS IMPLANTED FOR MORE THAN 6 MONTHS. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH BREAST IMPLANTS.

    Patient problems: Failure of Implant

    MAUDE report 6815853 ↗
  • InjuryAug 23, 2017Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION OF A TISSUE EXPANDER AND THAT THE "MEDIAL TABS WERE TORN". DEVICE WAS IMPLANTED FOR MORE THAN 6 MONTHS. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH BREAST IMPLANTS.

    Patient problems: Failure of Implant

    MAUDE report 6815839 ↗

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