Natrelle 133S Tissue Expanders 133S-MV-12-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MV-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
- 9
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628043862), received between Jan 5, 2021 and Feb 24, 2025 — classified as 6 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 Leak5
- Deflation Problem2
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED "APPEARS TO BE SOMETHING EMBEDDED IN THE CENTER OF THE EXPANDER" THE DEVICE WAS NEVER IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21444187 ↗InjuryNov 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, RIGHT-SIDED EXPANDER RUPTURED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15835496 ↗InjuryOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE LEAKING EXPANDER. DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15672595 ↗InjuryAug 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15298596 ↗MalfunctionDec 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
HEALTHCARE PROFESSIONAL REPORTED VIA JOURNAL ARTICLE TITLED "DISLODGEMENT OF TISSUE EXPANDER PORTS IN A PATIENT WITHOUT TRAUMA OR MRI HISTORY" THAT THE MAGNETIC PORT OF A TISSUE EXPANDER BECAME DISLODGED ON LEFT SIDE. THE TISSUE EXPANDER WAS IMPLANTED FOR A PERIOD GREATER THAN SIX MONTHS. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13052302 ↗MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
HEALTHCARE PROFESSIONAL REPORTED VIA JOURNAL ARTICLE TITLED "DISLODGEMENT OF TISSUE EXPANDER PORTS IN A PATIENT WITHOUT TRAUMA OR MRI HISTORY" THAT THE MAGNETIC PORT OF A TISSUE EXPANDER BECAME DISLODGED ON RIGHT SIDE. THE TISSUE EXPANDER WAS IMPLANTED FOR A PERIOD GREATER THAN SIX MONTHS. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046664 ↗InjuryJan 13, 2021Adverse 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 AND DISCARDED AFTER SURGERY.
Patient problems: Unspecified Infection
MAUDE report 11164924 ↗InjuryJan 5, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11118096 ↗InjuryJan 5, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11118017 ↗
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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