Natrelle 133S Tissue Expanders 133S-MV-13-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MV-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 Allergan Natrelle 133S tissue expander is an inflatable implant placed under the skin to gradually stretch tissue before reconstructive surgery. The 30 adverse event reports mostly describe fluid or blood leaking out of the expander, rupture or breaking of the device, expanders losing their shape or deflating, and the implant shifting position within the body. Reports also describe infections after surgery and fluid collections around the implant. There were 26 injuries and no deaths. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628043879), received between Jun 9, 2020 and Sep 3, 2026 — classified as 27 injuries, 3 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 Problem8
- Break2
- Deflation Problem2
- Migration2
- Device Contaminated During Manufacture or Shipping1
- Device Contamination with Chemical or Other Material1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant19
- Unspecified Infection7
- Seroma2
- Abscess1
- Foreign Body Reaction1
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "She felt heat and felt the expander move so the MRI was aborted. She subsequently developed worsening mastectomy flap necrosis requiring explant of the tissue expander". This record is for the left side. The device was explanted.
Patient problems: Necrosis
MAUDE report 50599301 ↗InjuryMar 31, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24746920 ↗InjuryMar 31, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24746651 ↗InjuryJan 23, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER WAS DEFLATED UPON REMOVAL". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24168416 ↗InjuryJan 8, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED "SHE FELT SOME TEARING IN THE LOWER ASPECT OF HER BREASTS, SHE SAID THE SHAPE WAS WEIRD FOR A WHILE, BUT THEN WENT BACK TO NORMAL. AND THEN SLOWLY THE EXPANDERS MIGRATED DOWNWARD". DEVICE WAS EXPLANTED AND IT'S UNKNOWN IF IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24006026 ↗InjuryJan 8, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED "SHE FELT SOME TEARING IN THE LOWER ASPECT OF HER BREASTS, SHE SAID THE SHAPE WAS WEIRD FOR A WHILE, BUT THEN WENT BACK TO NORMAL. AND THEN SLOWLY THE EXPANDERS MIGRATED DOWNWARD". DEVICE WAS EXPLANTED AND IT'S UNKNOWN IF IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 24005126 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENTS HAVE ALL DEVELOPED POST OP INFECTIONS". DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22330824 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "PATIENTS HAVE ALL DEVELOPED POST OP INFECTIONS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22330676 ↗InjuryJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22324854 ↗MalfunctionMay 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED "PERCOLATION AND SPOTS OF SAND WITHIN THE TISSUE EXPANDER OF SHELL AND FILL PORT AREA." BACKUP DEVICE USED TO COMPLETE SURGERY. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106513 ↗InjurySep 21, 2023Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL LATER, ALSO REPORTED, "HOLE NON-SPECIFIC. AND AT JUNCTION OF EXPANDER PORT MEETS EXPANDER, DERMA BOND ON IT. LEAK AT 4:00 POSITION. SLOWLY, DEFLATING DID NOT HOLD VOLUME". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17787996 ↗InjuryJul 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION OF A TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER EXPANDER.
Patient problems: Failure of Implant
MAUDE report 17324095 ↗InjuryMay 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE REMOVAL WAS NOTED AS "EXPANDER EXPOSED¿. DEVICE WAS EXPLANTED.
Patient problems: Foreign Body Reaction
MAUDE report 16940492 ↗InjuryMar 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
SALES REPRESENTATIVE REPORTED AN RIGHT SIDE DEFLATION OF A TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16650026 ↗InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "TISSUE EXPANDER MAY HAVE CAUSED AN INFECTION." DEVICE STATUS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 16601566 ↗InjuryJan 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "RUPTURED" TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16210081 ↗InjuryNov 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "TISSUE EXPANDER RUPTURE" THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15838720 ↗InjuryNov 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "TISSUE EXPANDER RUPTURE" THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15835464 ↗InjuryOct 12, 2022Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION OF TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15592443 ↗InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "ONE OF MY BREAST TISSUE EXPANDER HAD TO BE REMOVED BECAUSE OF INFECTION". THE RECORD RELATES TO THE UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15496296 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "OPENING OF WOUND AND COLLECTION." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma; Wound Dehiscence
MAUDE report 15433435 ↗InjuryJul 27, 2022Deflation Problem; Deflation Problem
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE TISSUE EXPANDER HAD "LEAKED". DEVICE WAS EXPLANTED.
Patient problems: Abscess; Failure of Implant
MAUDE report 15117034 ↗InjuryMay 12, 2022Break; Break
COMPANY REPRESENTATIVE REPORTED RIGHT SIDE SMALL HOLE ON THE OUTER SHELL OF A TISSUE EXPANDER IMPLANT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14378196 ↗MalfunctionMar 24, 2022Break; Break
HEALTHCARE PROFESSIONAL REPORTED THAT A TISSUE EXPANDER "WOULD NOT HOLD FLUIDS." THE DEVICE WAS NEVER IMPLANTED. IT IS UNKNOWN IF A REPLACEMENT DEVICE WAS USED TO COMPLETE SURGERY.
Patient problems: Failure of Implant
MAUDE report 13892299 ↗InjuryJan 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13227616 ↗
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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