Natrelle 133S Tissue Expanders 133S-FV-12-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-FV-12-T (US) · Class U · Implant
All models of Natrelle Breast Implants (1167) · Natrelle 133S Tissue Expanders (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888628043787), received between Jul 22, 2021 and Oct 15, 2025 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Fluid/Blood Leak2
Patient problems
- Failure of Implant4
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "EXPANDAR WAS NOT FIRM. THE SURGEON ATTEMPTED TO FILL THE EXPANDER AND NOTED THE IMPLANT DID NOT HOLD THE CC'S", "NOTED A SMALL PUNCTURE IN THE EXPANDER ADJACENT TO THE INFEROMEDIAL TAB". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23293281 ↗InjurySep 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED ON BEHALF OF PHYSICIAN, ¿THE IMPLANTED TISSUE EXPANDER HAD DEFLATED". PHYSICIAN LATER REPORTED "HOLE, NON-SPECIFIC." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17668337 ↗InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPANY REPRESENTATIVE REPORTED "PATIENT HAD AN INFECTION". DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16837463 ↗InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPANY REPRESENTATIVE REPORTED "MADE AWARE A PATIENT HAS AN INFECTION WHO HAD RECENT BREAST RECON". THIS IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16645732 ↗InjuryMar 23, 2022Break; Break
NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PORTION OF THE FRONT OF THE EXPANDER STICKING TO THE BACK. DEVICE NOT IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13865360 ↗MalfunctionJul 23, 2021Break; Break
HEALTHCARE PROFESSIONAL REPORTED "PUT IN A TISSUE EXPANDER AND CLOSED SKIN AND NOTICED THAT IT LOOKED LIKE THE TISSUE EXPANDER WAS NOT HOLDING FLUID. SO REOPENED THE BREAST AND PLACED A SECOND TISSUE EXPANDER". SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: Failure of Implant
MAUDE report 12217615 ↗MalfunctionJul 22, 2021Break; Break
HEALTHCARE PROFESSIONAL REPORTED "PUT IN A TISSUE EXPANDER AND CLOSED SKIN AND NOTICED THAT IT LOOKED LIKE THE TISSUE EXPANDER WAS NOT HOLDING FLUID. SO REOPENED THE BREAST AND PLACED A SECOND TISSUE EXPANDER". SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: Failure of Implant
MAUDE report 12211485 ↗
Other Expander, Skin, Inflatable devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHMentor Texas L.P. · Expander, skin, inflatable1 recall18 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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