MENTOR MemoryGel Breast Implant 3545270Recalls & reported problems
Mentor Texas L.P. · SILTEX Round Ultra High Profile Silicone Gel-Filled Breast Implant, 270cc |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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317007098), received between Nov 14, 2019 and Jan 14, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (2 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
- Adverse Event Without Identified Device or Use Problem3
- Material Rupture2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Capsular Contracture4
- No Code Available2
- Deformity/ Disfigurement1
- Impaired Healing1
- Local Reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Material Rupture; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A 270CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED INTRAOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071023 ↗InjuryDec 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement; Local Reaction
MAUDE report 23695213 ↗InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, THERE WERE HEALING ISSUES IN THE RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL BREAST PROSTHESIS ON (B)(6) 2024.
Patient problems: Capsular Contracture; Impaired Healing
MAUDE report 19346655 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN BOTH BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; No Code Available
MAUDE report 9324753 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN BOTH BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; No Code Available
MAUDE report 9324752 ↗
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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
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 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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