Natrelle 133S Tissue Expanders 133S-MX-14-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MX-14-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 Allergan Natrelle tissue expander is an inflatable implant used to stretch skin. Reports mostly describe the expander leaking and deflating from tiny holes or seam tears, sometimes after flipping out of position, often leading to removal, with a few infections mentioned. There are 26 reports naming its identifier, including no deaths and 21 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
- 25
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10888628044203), received between Oct 24, 2019 and Jul 2, 2025 — classified as 20 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 Leak14
- Adverse Event Without Identified Device or Use Problem7
- Break4
- Malposition of Device2
- Defective Device1
- Deflation Problem1
- Device Handling Problem1
Patient problems
- Failure of Implant16
- Unspecified Infection4
- Fluid Discharge2
- Cellulitis1
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "CELLULITIS OF RIGHT BREAST". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Cellulitis
MAUDE report 22386264 ↗MalfunctionJun 10, 2025Break; Malposition of Device; Break; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXPANDER GOT PUNCTURED AFTER FLIPPING. LATER HEALTHCARE PROFESSIONAL REPORTED " FLIPPED AFTER PLACEMENT". DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22181062 ↗InjuryJun 10, 2025Break; Malposition of Device; Device Handling Problem; Break; Malposition of Device; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED EXPANDER GOT PUNCTURED AFTER FLIPPING. LATER HEALTHCARE PROFESSIONAL REPORTED "FLIPPED AFTER PLACEMENT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22175003 ↗InjuryJul 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED RIGHT SIDE "HAVE A PROBLEM WITH AN IMPLANT." LATER, HEALTHCARE PROFESSIONAL REPORTED "RIGHT TE HAD DEFLATED" AND "WE FOUND A VERY TINY HOLE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17007627 ↗InjuryNov 17, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 15815424 ↗MalfunctionNov 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE TEAR IN THE SEAM, CAUSING THE DEVICE TO DEFLATE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15779305 ↗InjuryOct 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "PATIENT INFECTION ¿ CULTURE INDICATED MOLD" FOR AN UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15697493 ↗InjuryOct 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING EXPANDER" FOR AN UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15697292 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION" AGAINST RIGHT DEVICE. THE DEVICE IS NOT IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 14323398 ↗InjuryMar 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED "PUNCTURED" AGAINST UNKNOWN SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13690613 ↗InjuryAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE TISSUE EXPANDER "DEFLATED WHILE PATIENT WAS IN RECOVERY." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12362670 ↗InjuryJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12176719 ↗MalfunctionFeb 4, 2021Defective Device; Defective Device
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "DEFECTIVE TISSUE EXPANDER, CIRCLE IS IN THE WRONG PLACE." DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11279317 ↗InjuryJan 7, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "BELIEVED TO HAVE A LEAK". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11132291 ↗InjurySep 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROVIDER REPORTED AN UNKNOWN SIDE "EXPANDER HAD DEFLATED." DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.
Patient problems: Failure of Implant
MAUDE report 10592109 ↗InjurySep 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROVIDER REPORTED "TISSUE EXPANDER NOT FILL IN CLINIC. WE HAD PUT IN 325CC IN THE TISSUE EXPANDER BUT IT WAS ALWAYS LOOKING MORE DEFLATED THAN THE OTHER SIDE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10557027 ↗InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED "LEAKAGE OF FLUID FROM THE BREAST,¿ ¿SWELLING,¿ ¿FEARS [PATIENT] WILL AGAIN DEVELOP CANCER,¿ ¿ENDURED CONTINUOUS EMOTIONAL DISTRESS,¿ ¿INCREASED RISK OF DEVELOPING BIA-ALCL,¿ ¿PAIN," "DISCOMFORT¿, ¿SORENESS,¿, AND THE DEVICE WAS IMPLANTED LONGER THAN INDICATED IN DEVICE LABELING. PATIENT REPRESENTATIVE ALSO REPORTED ¿SUFFERING,¿ THIS IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Fluid Discharge
MAUDE report 10493101 ↗InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED "LEAKAGE OF FLUID FROM THE BREAST,¿ ¿SWELLING,¿ ¿FEARS [PATIENT] WILL AGAIN DEVELOP CANCER,¿ ¿ENDURED CONTINUOUS EMOTIONAL DISTRESS,¿ ¿INCREASED RISK OF DEVELOPING BIA-ALCL,¿ ¿PAIN," "DISCOMFORT¿, ¿SORENESS,¿, AND THE DEVICE WAS IMPLANTED LONGER THAN INDICATED IN DEVICE LABELING. PATIENT REPRESENTATIVE ALSO REPORTED ¿SUFFERING,¿ THIS IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Fluid Discharge
MAUDE report 10493090 ↗MalfunctionSep 1, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY A "PUNCTURE IN THE FILL PORT". DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10475959 ↗InjuryAug 19, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "NECROSIS" AND "UPON OPENING THE SKIN NOTICED ONE OF THE TABS HAD COME OFF OF THE EXPANDER, SURGEON NEEDED TO SCRAP EVERYTHING, AND START OVER WITH A NEW DEVICE." DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.
Patient problems: Necrosis
MAUDE report 10424532 ↗MalfunctionJul 17, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "NATRELLE TISSUE EXPANDER WOULD NOT COMPLETELY FILL, IT UNKNOWINGLY GOT PUNCTURED, BUT THERE WERE NO RUPTURES OR LEAKS. IT JUST WASN¿T GETTING THE VOLUME NEEDED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10289902 ↗InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PSEUDOMONAS INFECTION REQUIRING REMOVAL." DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9769605 ↗InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PSEUDOMONAS INFECTION." DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9745552 ↗InjuryOct 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "2 MM HOLE SEVERAL CENTIMETERS MEDIAL TO THE FILL PORT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9234072 ↗
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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