Natrelle 133S Tissue Expanders 133S-MV-15-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MV-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 tissue expander is an inflatable implant used to stretch skin before breast reconstruction. The 29 reports mostly describe fluid or blood leaking from the expander, along with infections after surgery and the implant failing to stay in place; 27 reports involved injuries and no deaths were reported. Several mention tears, ruptures or a seam splitting open, and skin redness or tightening around the area. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628043893), received between Jan 8, 2020 and Dec 10, 2025 — classified as 27 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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 Leak17
- Adverse Event Without Identified Device or Use Problem7
- Break2
- Deflation Problem1
- Device Appears to Trigger Rejection1
- Device Contaminated During Manufacture or Shipping1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant21
- Unspecified Infection6
- Seroma3
- Capsular Contracture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED AT THE PATCH". THIS RECORD IS FOR THE UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23771936 ↗InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SOME AREAS OF CREASING OF THE EXPANDER" AND "SOME SKIN ERYTHEMA". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS TREATED WITH ACCOLATE AND IMPLANT REMOVAL. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23582928 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE OF ALL LAST 3 CONSECUTIVE TISSUE EXPANDER BREAST RECONSTRUCTION DEVELOPED POST OP INFECTIONS". DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22331750 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE OF ALL LAST 3 CONSECUTIVE TISSUE EXPANDER BREAST RECONSTRUCTION DEVELOPED POST OP INFECTIONS". DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22331738 ↗InjuryMar 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 21499585 ↗InjuryNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18134800 ↗InjuryOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
SALES REPRESENTATIVE REPORTED A "TEAR ON THE SEAM" OF THE DEVICE FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17869913 ↗InjuryMar 20, 2023Deflation Problem; Deflation Problem
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE TISSUE EXPANDER "LEAKING UPON REMOVAL". DEVICE EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16576901 ↗InjuryFeb 28, 2023Adverse 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 REPLACED.
Patient problems: Unspecified Infection
MAUDE report 16452729 ↗InjuryFeb 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "DEFLATED TISSUE EXPANDERS DUE TO RADIATION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 16370943 ↗InjuryFeb 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "DEFLATED TISSUE EXPANDERS DUE TO RADIATION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 16370931 ↗InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED " SUPERIOR-MEDIAL TAB HAD DETACHED FROM THE EXPANDER" AND SEROMA. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 15739352 ↗InjurySep 28, 2022Break; Break
HEALTH CARE PROFESSIONAL REPORTED ONE OF THE TABS OF THE TISSUE EXPANDER WAS FREE FLOATING IN THE POCKET. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15498521 ↗MalfunctionAug 2, 2022Break; Break
REPRESENTATIVE REPORTED ¿A TAB HAD RIPPED OFF THE TISSUE EXPANDER¿. PATIENT CONTACT WAS MADE WITH THE DEVICE. DEVICE IMPLANTED. SIDE UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 15148024 ↗InjuryMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED "DEFLATION" AGAINST UNKNOWN SIDE TISSUE EXPANDER. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13957594 ↗InjuryMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13667742 ↗InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A INFECTED RIGHT EXPANDER. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 13563750 ↗InjuryFeb 2, 2022Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 13424564 ↗InjuryJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13367444 ↗InjuryOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED UNKNOWN SIDE "TISSUES EXPANDER HAS BEEN LEAKING AND GOING FLAT.¿ DEVICE HAS BEEN IMPLANTED FOR MORE THAN SIX MONTHS. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12584083 ↗InjuryJun 7, 2021Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED, UNKNOWN SIDE DEFLATION OF A TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11948027 ↗MalfunctionMar 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED AN IMPLANT WITH "RANDOM MATERIAL STUCK ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.
Patient problems: Failure of Implant
MAUDE report 11446541 ↗InjuryFeb 19, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED AN UNKNOWN SIDE "RIPPED TE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11351766 ↗InjuryDec 7, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED FOR UNKNOWN SIDE "ONE OF MY DOCS INFORMED ME ABOUT A RUPTURED TISSUE EXPANDER." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10960459 ↗InjuryNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10897029 ↗
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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