Natrelle 133S Tissue Expanders 133S-FX-13-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-FX-13-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
- 13
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628044036), received between May 19, 2020 and May 6, 2026 — classified as 11 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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
- Fluid/Blood Leak7
- Adverse Event Without Identified Device or Use Problem4
- Break1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant7
- Unspecified Infection3
- Impaired Healing2
- Foreign Body Reaction1
- No Patient Involvement1
- Swelling/ Edema1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "INFECTION AND WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 25103779 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "POOR WOUND HEALING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing
MAUDE report 23052728 ↗InjuryAug 31, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
ALLERGAN REPRESENTATIVE REPORTED "INFERIOR TAB THAT WAS DISLODGED IN THE POCKET OF THE PATIENT AND CAUSED IT TO BE EXPOSED WITH A SCAB. UPON REMOVAL OF THE TISSUE EXPANDER IT WAS IDENTIFIED THAT THE INFERIOR TAB HAD TORN AWAY FROM TISSUE EXPANDER." TISSUE EXPANDER HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Foreign Body Reaction
MAUDE report 17659587 ↗InjuryApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16753140 ↗InjuryApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16726837 ↗InjuryApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16696973 ↗InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 13971679 ↗InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED FOR AN UNKNOWN SIDE "CAUGHT AN INFECTION IN MY ARM WHICH HAS LYMPHEDEMA" AND ASKED IF THE "TISSUE EXPANDER IS APART OF THE RECALL". THE DEVICE REMAINS IMPLANTED.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 12513640 ↗MalfunctionDec 22, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "HAD A SMALL HOLE IN IT.¿ DEVICE WAS NOT IMPLANTED.
Patient problems: No Patient Involvement
MAUDE report 11057414 ↗InjuryOct 23, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "DEFLATION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10730681 ↗InjuryOct 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "DEFLATION". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10717766 ↗MalfunctionOct 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 10712805 ↗InjuryMay 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10071000 ↗
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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