Natrelle 133S Tissue Expanders 133S-MX-16-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MX-16-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
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628044227), received between Jul 22, 2020 and Sep 9, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 Leak8
- Deflation Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection1
Patient problems
- Failure of Implant11
- Unspecified Infection3
- Impaired Healing2
- Seroma1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50699888 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "delayed wound healing" and "infection". This record is for left side. The device was explanted.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50699510 ↗InjuryAug 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE TISSUE EXPANDER DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17651939 ↗InjuryMay 1, 2023Deflation Problem; Deflation Problem
InjuryFeb 3, 2023Deflation Problem; Deflation Problem
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE "DEFLATION OF A TISSUE EXPANDER". THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16293964 ↗InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "LOOKS LIKE IT HAS EITHER FOLDED AND CAUSED THE PORT TO SHIFT, OR LIKE THE PORT HAS ACTUALLY SEPARATED FROM THE TOP OF THE EXPANDER AND IS FLOATING IN THE MIDDLE. WE WERE WONDERING IF YOU HAVE HAD ANY REPORTED CASES OF EXPANDER DEFECTS WHERE THE PORT HAS COLLAPSED OR DETACHED/SEPARATED FROM THE SHELL¿. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15513260 ↗InjuryAug 2, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15151762 ↗InjuryMay 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14497826 ↗InjuryMar 10, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE TISSUE EXPANDER WITH "4 HOLES IN THE LOWER POLE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Seroma; Unspecified Infection
MAUDE report 11457309 ↗InjuryMar 4, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11417471 ↗InjuryNov 3, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING EXPANDER" ON AN UNKNOWN SIDE, "EXPANDER HAD FLIPPED", "POSSIBLE THE DEVICE HAD MOVED", AND ¿PATIENT ¿WINCED¿ SUGGESTING THAT POSSIBLY PATIENT FELT THE NEEDLE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10780007 ↗InjurySep 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjuryJul 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10311080 ↗
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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