MENTOR Tissue ExpanderRecalls & reported problems across all models
Mentor Texas L.P. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 184
- Deaths reported
- 0
- Injuries reported
- 136
- Recalls
- 0
We found 15 models of MENTOR Tissue Expander by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 184 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2018 and Sep 21, 2026 — classified as 136 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (146 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MENTOR Tissue Expander problems
Device problems
- Material Rupture146
- Off-Label Use25
- Use of Device Problem15
- Infusion or Flow Problem8
- Adverse Event Without Identified Device or Use Problem6
- Inflation Problem5
- Connection Problem4
- Manufacturing, Packaging or Shipping Problem4
Patient problems
- No Code Available61
- Deformity/ Disfigurement46
- Insufficient Information30
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient20
- No Patient Involvement12
- Pain7
- No Known Impact Or Consequence To Patient6
MENTOR Tissue Expander models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR Tissue Expander 3504307MEXPANDER, SKIN, INFLATABLE47 reports
- MENTOR Tissue Expander 3504305MEXPANDER, SKIN, INFLATABLE44 reports
- MENTOR Tissue Expander 3504310MEXPANDER, SKIN, INFLATABLE20 reports
- MENTOR Tissue Expander 3504303MEXPANDER, SKIN, INFLATABLE16 reports
- MENTOR Tissue Expander 3504311MEXPANDER, SKIN, INFLATABLE15 reports
- MENTOR Tissue Expander 3504302MEXPANDER, SKIN, INFLATABLE12 reports
- MENTOR Tissue Expander 3504304MEXPANDER, SKIN, INFLATABLE9 reports
- MENTOR Tissue Expander 3505305MEXPANDER, SKIN, INFLATABLE7 reports
- MENTOR Tissue Expander 3504301MEXPANDER, SKIN, INFLATABLE5 reports
- MENTOR Tissue Expander 3504315MEXPANDER, SKIN, INFLATABLE3 reports
- MENTOR Tissue Expander 3504317MEXPANDER, SKIN, INFLATABLE2 reports
- MENTOR Tissue Expander 3504308MEXPANDER, SKIN, INFLATABLE1 report
- MENTOR Tissue Expander 3504313MEXPANDER, SKIN, INFLATABLE1 report
- MENTOR Tissue Expander 3505301MEXPANDER, SKIN, INFLATABLE1 report
- MENTOR Tissue Expander 3505306MEXPANDER, SKIN, INFLATABLE1 report
Recent MENTOR Tissue Expander adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848308 ↗MalfunctionJun 1, 2026Material Rupture
IT WAS REPORTED THAT A 400CC MENTOR TISSUE EXPANDER PROSTHESIS WAS OBSERVED TO LEAK DURING A BREAST SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25347931 ↗MalfunctionApr 6, 2026Material Rupture
IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER WAS FOUND TO BE DEFLATED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792204 ↗InjuryNov 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23510839 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED AN INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.
Patient problems: Post Operative Wound Infection
MAUDE report 23342379 ↗InjuryOct 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23337688 ↗MalfunctionAug 15, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT DURING IMPLANTATION SURGERY OF A 100CC MENTOR TISSUE EXPANDER PROSTHESIS; A SOLUTION INJECTION TEST WAS PERFORMED. THERE WAS RESISTANCE TO FILL THE DEVICE AND SUBSEQUENT BULGE AND AN INABILITY TO FILL WAS ENCOUNTERED. NO DELAYS, ADVERSE EVENTS, OR PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816174 ↗InjuryAug 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A 700CC MENTOR TISSUE EXPANDER IN THE RIGHT FLANK FOR TISSUE EXPANSION OF SCARRED SKIN AREAS. POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE A DEFLATED IMPLANT AND YELLOW FLUID WAS NOTED ON ASPIRATION OF THE AREA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH UNDISCLOSED EXPANDERS ON (B)(6) 2024.
Patient problems: Local Reaction
MAUDE report 22810278 ↗InjuryAug 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A 550CC MENTOR TISSUE EXPANDER IN THE RIGHT SHOULDER FOR TISSUE EXPANSION OF SCARRED SKIN AREAS. POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE A DEFLATED IMPLANT AND YELLOW FLUID WAS NOTED ON ASPIRATION OF THE AREA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH UNDISCLOSED EXPANDERS ON (B)(6) 2024.
Patient problems: Local Reaction
MAUDE report 22810277 ↗InjuryMay 8, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR TISSUE EXPANDER 550CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER WAS REPORTED. ADDITIONALLY, THE PATIENT EXPERIENCE AN ALLERGIC REACTION ONE DAY POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER 550CC DEVICE ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement; Hypersensitivity/Allergic reaction
MAUDE report 21990694 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR TISSUE EXPANDER 550CC TISSUE EXPANDERS WHEN THE RIGHT BREAST TISSUE EXPANDER DEFLATED POST IMPLANTATION. THE DEFLATION WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE ULTRASOUND RESULTS INDICATED CYSTS IN BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Cyst(s)
MAUDE report 21716128 ↗InjuryMar 27, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR TISSUE EXPANDER 550CC TISSUE EXPANDERS WHEN THE RIGHT BREAST TISSUE EXPANDER DEFLATED POST IMPLANTATION. THE DEFLATION WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE ULTRASOUND RESULTS INDICATED CYSTS IN BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Cyst(s)
MAUDE report 21716127 ↗InjuryMar 21, 2025Component Missing; Component Missing
A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR TISSUE EXPANDER EXP RECT REMOTE 250 CC SALINE PROSTHESIS EXPERIENCED FILL TUBING ISSUE INTRAOPERATION. THE EXPANDER CAME IN CONTACT, METAL PIECE USED TO RECONNECT TUBBING WHEN ADJUSTING LENGTH OF EXPANDER WAS MISSING, DR HAD TO REUSE THE PREVIOUS EXPANDER TUBBING TO COMPLETE THE PROCEDURE. THIS ISSUE CAUSED PROCEDURAL DELAY. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21666089 ↗InjuryFeb 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTION SURGERY WITH A MENTOR TISSUE EXPANDER 400CC DEVICE THAT WAS SUSPECTED TO HAVE DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21376700 ↗MalfunctionDec 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A 550CC MENTOR TISSUE EXPANDER PACKAGE WAS OPENED PRE-OPERATIVELY AND OBSERVED TO HAVE A HAIR INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENTS AS THE EVENT OCCURRED PRE-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20968583 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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