Natrelle 133S Tissue Expanders 133S-FX-15-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-FX-15-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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628044050), received between Nov 1, 2021 and Jul 17, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- Failure of Implant4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION OF A TISSUE EXPANDER AT EXPLANT, FOUND A 7MM HOLE IN THE EXPANDER. DEVICE WAS REPLACED WITH ANOTHER TISSUE EXPANDER.
Patient problems: Failure of Implant
MAUDE report 17336838 ↗InjuryApr 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "PATIENT IN PROCESS OF TISSUE EXPANSION WHEN SURGEON NOTICED THE LEFT RECONSTRUCTED BREAST HAD GONE FLAT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16734570 ↗InjuryApr 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED "LEAKING" AGAINST RIGHT SIDE DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14164562 ↗InjuryNov 1, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "LEAKING EXPANDER." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12728665 ↗
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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