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Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-14-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133MX With Sut Tab, 600cc. · 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
11
Deaths reported
0
Injuries reported
10
Recalls naming it
1

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628004498), received between Sep 21, 2017 and Mar 15, 2021 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
  • Adverse Event Without Identified Device or Use Problem3
  • Device Contamination with Chemical or Other Material1

Patient problems

  • Failure of Implant7
  • Deformity/ Disfigurement2
  • No Patient Involvement1
  • Unspecified Infection1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REPORTED LEFT SIDE "PAIN" AND "SWELLING" AND DEVICE WAS IMPLANTED FOR LONGER THAN 6 MONTHS. PATIENT ADDITIONALLY REPORTED INFECTION. DEVICE WAS EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 11490000 ↗
  • InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REPORTED ¿I HAVE NO CLEAVAGE LINE, ITS JUST ONE BIG BOOB. I'VE BEEN HAVING SHARP PAIN." DEVICE REMAINS IMPLANTED. UNKNOWN SIDE.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 9033371 ↗
  • InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REPORTED ¿I HAVE NO CLEAVAGE LINE, ITS JUST ONE BIG BOOB. I'VE BEEN HAVING SHARP PAIN." UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 9022037 ↗
  • InjuryJun 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

    THE EVENTS OCCURRED ON THE LEFT SIDE.

    Patient problems: Failure of Implant

    MAUDE report 8736383 ↗
  • InjuryJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTH PROFESSIONAL REPORTED A "DAMAGED TISSUE EXPANDER" THAT WAS "NOT HOLDING ITS FILL." PATIENT WAS REPLACED WITH ANOTHER TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR AN UNKNOWN SIDE.

    Patient problems: Failure of Implant

    MAUDE report 8712645 ↗
  • InjuryJan 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

    Patient problems: Failure of Implant

    MAUDE report 8219083 ↗
  • MalfunctionSep 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    HEALTHCARE PROFESSIONAL REPORTED, "TISSUE EXPANDER APPEARS TO HAVE WHITE SPECKS ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

    Patient problems: No Patient Involvement

    MAUDE report 7901761 ↗
  • InjuryNov 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

    HEALTH PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 7002900 ↗
  • InjuryOct 2, 2017Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A DEFLATION ON AN UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 6907146 ↗
  • InjurySep 29, 2017Fluid/Blood Leak; Fluid/Blood Leak

    HEALTH PROFESSIONAL REPORTED A LEFT SIDE EXPANDER "LEAK" AND THEY "SQUEEZED IT TO TEST IT [POST EXPLANT] AND THE EXPANDER BUSTED". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 6903296 ↗
  • InjurySep 21, 2017Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A "LEAK" FOR A TISSUE EXPANDER. DEVICE WAS IMPLANTED FOR 19 MONTHS. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 6882557 ↗

Other Expander, Skin, Inflatable devices

All Expander, Skin, Inflatable devices →

Sources and updates

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