Natrelle 133S Tissue Expanders 133S-SX-15-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-SX-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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628043978), received between Dec 6, 2019 and Mar 7, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak3
- Improper or Incorrect Procedure or Method2
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN-SIDE "EXPANDER THAT WAS LEAKING". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "IT WAS PIN HOLE BUT I MADE IT WORSE INSPECTING THE AREA AND SQUEEZING TO SEE WHERE IT WAS LEAKING FROM SO THE HOLE IS BIGGER NOW". DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21550716 ↗InjuryFeb 7, 2020Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "BURST APART" AND ¿DOCTOR HAD PLANNED TO TAKE THE RIGHT SIDE EXPANDER AND MOVE IT TO THE LEFT SIDE¿. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9682581 ↗InjuryDec 6, 2019Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL REPORTED A TISSUE EXPANDER THAT BURST APART DURING SURGERY AND ¿DOCTOR HAD PLANNED TO TAKE THE RIGHT SIDE EXPANDER AND MOVE IT TO THE LEFT SIDE¿. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9430128 ↗
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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