MENTOR MemoryGel Breast Implant 3544257MCRecalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 425cc |Textured|Round|Silicone| · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Breast Implant (211)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317004455), received between Jul 20, 2021 and May 14, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Material Rupture” (6 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
- Material Rupture6
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Deformity/ Disfigurement4
- Capsular Contracture2
- Seroma1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22019020 ↗InjuryMay 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22019010 ↗InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 425CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND POSSIBLE LEFT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE II. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE IV. THIS WAS ACCOMPANIED BY PAIN AND DISCOMFORT. AS A RESULT, REPLACEMENT WITH MENTOR GEL IS PLANNED FOR (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 20419293 ↗InjuryOct 10, 2024Material Rupture; Material Rupture
T WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 425CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND POSSIBLE LEFT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE II. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE IV. THIS WAS ACCOMPANIED BY PAIN AND DISCOMFORT. AS A RESULT, REPLACEMENT WITH MENTOR GEL IS PLANNED FOR (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 20419267 ↗InjuryAug 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 20022478 ↗InjuryJul 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT (SX MOD CLASSIC GEL, 425CC, DATE OF IMPLANT (B)(6) 2014) ON BOTH SIDES AND EXPERIENCED BREAST IMPLANTS RUPTURE BILATERALLY. IT WAS ALSO REPORTED THAT THE PATIENT HAS DEVELOPED LATE ONSET SEROMA IN THE LEFT BREAST. NO INFORMATION WAS PROVIDED REGARDING TESTING OF THE SEROMA FLUID. AT THIS TIME, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 12196023 ↗InjuryJul 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT (SX MOD CLASSIC GEL, 425CC, DATE OF IMPLANT (B)(6) 2014) ON BOTH SIDES AND EXPERIENCED BREAST IMPLANTS RUPTURE BILATERALLY. IT WAS ALSO REPORTED THAT THE PATIENT HAS DEVELOPED LATE ONSET SEROMA IN THE LEFT BREAST. NO INFORMATION WAS PROVIDED REGARDING TESTING OF THE SEROMA FLUID. AT THIS TIME, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Seroma
MAUDE report 12196020 ↗
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- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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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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