Natrelle 133S Tissue Expanders 133S-MX-15-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MX-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
Quick summary
This Natrelle 133S Smooth tissue expander is an inflatable silicone implant placed under the skin to stretch tissue before breast reconstruction. The 28 reports mostly describe fluid leaking out or the expander breaking, tearing or deflating, sometimes with holes in it, and several needing removal and replacement because of infection or rupture. No deaths were reported; 22 reports involved injuries. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10888628044210), received between Dec 20, 2019 and Jul 27, 2026 — classified as 22 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 Leak19
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Deflation Problem1
- Delivered as Unsterile Product1
- Material Rupture1
Patient problems
- Failure of Implant19
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions3
- Seroma2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Fluid/Blood Leak
Healthcare Professional reported through sales representative "several holes in it". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037813 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER LEAK". THE RECORD IS FOR A DEVICE THAT WASN'T IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707101 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "INFECTION TE EXCHANGE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 23011388 ↗InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "INFECTION TE EXCHANGE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 22985920 ↗InjuryApr 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21845534 ↗InjuryNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
SALES REPRESENTATIVE REPORTED ON BEHALF OF THE HEALTHCARE PROFESSIONAL THAT THE DEVICE "HAD A HOLE". THIS IS FOR A UNKNOWN SIDE. DEVICE IS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18161100 ↗InjuryOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE TISSUE EXPANDER TORE/SEPARATED AT PORT AND SILICONE INTERFACE, NOTICEABLY DEFLATED. TISSUE EXPANDER HAS BEEN EXPLANTED AND REPLACED WITH IMPLANT.
Patient problems: Failure of Implant
MAUDE report 17950221 ↗InjuryJun 30, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17240828 ↗InjuryApr 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "LEFT SIDE DEFLATION" AND "SEVERAL HOLES". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16796104 ↗InjuryDec 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEFT BREAST TISSUE EXPANDER WAS QUITE A BIT SOFTER THAN IT HAD BEEN", "THE VOLUME SEEMED TO HAVE DECREASED", "RUPTURED LEFT BREAST TISSUE EXPANDER", AND "SOME SEROUS FLUID WITHIN THE TISSUE EXPANDER AND IT WAS NOTED TO HAVE FAILED AT A POSTERIOR SEAM OF THE 2 PIECE SHELL, AT ABOUT THE 1 O'CLOCK POSITION WHEN VIEWED ANTERIORLY". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 16017075 ↗InjuryDec 12, 2022Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "NOTICED A HOLE IN THE SEAM". DEVICE WAS EXPLANTED AND REPLACED WITH A BACKUP.
Patient problems: Failure of Implant; Seroma
MAUDE report 15962137 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "INFECTION" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN REPLACED.
Patient problems: Unspecified Infection
MAUDE report 15324433 ↗MalfunctionApr 28, 2022Break; Break
HEALTH CARE PROFESSIONAL REPORTED RIGHT SIDE "DURING IMPLANTATION SURGERY DOCTOR NOTICED DAMAGE NEAR THE 12 O'CLOCK TAB ON THE SEAM WHERE THE MAGNETIC PORT IS LOCATED.¿ THE DEVICE CAME IN CONTACT WITH THE PATIENT BUT WAS NOT IMPLANTED. SURGERY WAS NOT COMPLETED WITH A BACK UP DEVICE BUT RATHER WITH A BREAST IMPLANT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 14245502 ↗InjuryFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATED TISSUE EXPANDER.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13517252 ↗InjuryFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "PATIENT THAT TWO DEFLATED TISSUE EXPANDERS.¿ DEVICE REMAINS IMPLANTED. LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 13501650 ↗InjuryOct 8, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12599143 ↗InjuryMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER LEAKING." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11407220 ↗InjuryFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11301396 ↗MalfunctionDec 4, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED THAT WHILE IMPLANTING TISSUE EXPANDER, DEVICE RUPTURED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A BACK UP DEVICE. DEVICE WAS NOT IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10944145 ↗MalfunctionNov 13, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
HEALTHCARE PROFESSIONAL REPORTED A TISSUE EXPANDER THAT "DID NOT HAVE AN INNER STERILE WRAPPING." DEVICE WAS NOT IMPLANTED.
Patient problems: No Patient Involvement
MAUDE report 10837306 ↗InjuryNov 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "TEAR IN EXPANDER ALONG SEAM." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10784858 ↗MalfunctionNov 3, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED "EXPANDER WAS PUT IN THE PATIENT, BUT WOULD NOT PROPERLY FILL, IT WAS LIKE IT WAS 'USED CLOSED' ." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10781743 ↗MalfunctionSep 29, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED A DEVICE "APPEARED TO BE DEFLATING DURING THE EXPANSION PROCESS", AND "THEY WERE NOT ABLE TO PUT MUCH VOLUME IN THIS EXPANDER AT THE TIME OF IMPLANTATION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10599448 ↗InjurySep 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿RIGHT SIDE DEFLATION¿. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10531894 ↗InjuryAug 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" WITH A TISSUE EXPANDER FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10468710 ↗
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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