Natrelle 133S Tissue Expanders 133S-MX-13-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MX-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
Quick summary
This Natrelle 133S tissue expander is an inflatable implant used to stretch skin before breast reconstruction. The 39 adverse event reports mostly describe the expander leaking or deflating so it loses its volume, along with infection, skin breakdown (necrosis) and erosion, often leading to removal of the device. No deaths were reported; 35 injuries were. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628044197), received between Dec 16, 2019 and Mar 30, 2026 — classified as 35 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 Leak24
- Adverse Event Without Identified Device or Use Problem8
- Break2
- Device Appears to Trigger Rejection2
- Device Handling Problem2
- Material Rupture2
- Device Contamination with Chemical or Other Material1
Patient problems
- Failure of Implant26
- Unspecified Infection7
- Erosion3
- Necrosis2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "INFECTION", "SKIN NECROSIS" AND "WOUND PROBLEMS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Necrosis; Unspecified Infection
MAUDE report 24727991 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) INFECTION, SKIN NECROSIS. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Necrosis; Unspecified Infection
MAUDE report 24378963 ↗InjurySep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED EXPANDER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22968157 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDERS IMPLANTED ON 7/9 AND CAME BACK 3 WEEKS LATER WITH INFECTION". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22867450 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED INFECTION. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22843007 ↗InjuryAug 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22757579 ↗InjuryAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATED". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22738827 ↗InjuryMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿TISSUE EXPANDER KEPT DEFLATING AND WOULDN¿T MAINTAIN VOLUME¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21726581 ↗InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "CULTURES HAVE RECENTLY BEEN PERFORMED ON MAMMARY DRAINS IN WHICH PSEUDOMONAS AERUGINOSA HAS GROWN". THIS RECORD IS FOR THE UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Bacterial Infection; Purulent Discharge
MAUDE report 17926701 ↗InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED INFECTION AND SEROMA. THE DEVICE WAS DISCARDED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Seroma; Unspecified Infection
MAUDE report 17425243 ↗InjuryJun 27, 2023Material Rupture; Material Rupture
SALE REPS REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL LEFT SIDE "INFECTION DESPITE ANTIFUNGAL TREATMENT," ¿FULL OF PUSS¿ AND "A POSSIBLE PINHOLE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 17212919 ↗InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "CHRONIC DEFORMITY AND PAIN SECONDARY TO THE USE OF DEFECTIVE BREAST IMPLANTS", "REMOVED SECONDARY TO INFECTION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 17041050 ↗InjuryMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16979536 ↗MalfunctionApr 19, 2023Break; Break
HEALTHCARE PROFESSIONAL REPORTED NEW EXPANDER OUT OF THE BOX WAS LEAKING. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773213 ↗InjuryMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION, "NOT FULLY EXPANDED, TISSUE EXPANDER THAT ENDED UP WITH A BIG HOLE ON THE POSTERIOR SIDE OF THE EXPANDER". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16626179 ↗InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SALES REP REPORTED PATIENT EXPERIENCING "EXPANDER ERODING THROUGH SKIN" WITH TISSUE EXPANDERS ON THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Erosion
MAUDE report 16060472 ↗InjuryDec 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED "EXPANDER ERODING THROUGH SKIN". DEVICE REMAIN IMPLANTED.
Patient problems: Erosion
MAUDE report 16045838 ↗InjuryDec 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 4, 2022Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED UNKNOWN SIDE, "POCKET WAS TIGHT" AND "LEAK." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15727938 ↗InjuryOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "TISSUE EXPANDER DEFLATED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15676916 ↗InjuryOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15675695 ↗InjurySep 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION." AFFECTED SIDE IS UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15456188 ↗InjuryJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "HOLE" AGAINST LEFT DEVICE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15013633 ↗InjuryJun 30, 2022Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem
PATIENT REPORTED VIA REGULATORY AGENCY FOR UNKNOWN SIDE "17 MONTHS AFTER BEING IMPLANTED, ONE OF THE BREAST EXPANDERS RUPTURED". THE TISSUE EXPANDER REMAINED IMPLANTED FOR MORE THAN 6 MONTHS. THE STATUS OF THE DEVICE IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 14876369 ↗MalfunctionMay 24, 2022Break; Break
HEALTHCARE PROFESSIONAL REPORTED "MAGNET DETACHED FROM SHELL AND WAS FLOATING AROUND IN THE TE". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14492585 ↗
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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