MENTOR MemoryGel Breast Implant 3543507Recalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Profile Gel-Filled Breast Implant, 350cc · 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
Quick summary
This Mentor MemoryGel breast implant is a silicone gel implant used in breast augmentation. Most of the 181 reports describe the implant rupturing, with patients also reporting hardened scar tissue and deformity. The reports include 181 injuries and no deaths. There are no reports from the last 12 months, compared with 12 in the 12 months before. 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
- 182
- Deaths reported
- 0
- Injuries reported
- 182
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00081317000693), received between Feb 9, 2018 and Sep 28, 2026 — classified as 182 injuries.
The most frequently reported specific device problem is “Material Rupture” (163 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 Rupture163
- Adverse Event Without Identified Device or Use Problem24
- Gel Leak5
- Appropriate Device Problem Term/Code Not Available3
- Migration2
- No Apparent Adverse Event1
- Off-Label Use1
Patient problems
- No Code Available75
- Deformity/ Disfigurement59
- Capsular Contracture43
- Granuloma19
- Pain15
- Wrinkling9
- Breast Discomfort/Pain8
- Seroma6
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919095 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 23296848 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23295986 ↗InjuryAug 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 370CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 350CC GEL BREAST PROSTHESIS ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 22808895 ↗InjuryApr 21, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY INVOLVING MENTOR MEMORYGEL, 350CC SILICONE EXPERIENCED LEFT SIDED SILENT RUPTURE POST OPERATION. THE ISSUE WAS CONFIRMED THROUGH MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement; Granuloma
MAUDE report 21875466 ↗InjuryMar 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 400CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAMMOGRAM AND ULTRASOUND IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Deformity/ Disfigurement; Seroma
MAUDE report 21693635 ↗InjuryMar 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING ULTRASOUND AND MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21683083 ↗InjuryMar 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING ULTRASOUND AND MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21682363 ↗InjuryMar 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND BILATERAL BREAST PAIN POSTOPERATIVELY. MRI CONFIRMED RUPTURE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.
Patient problems: Breast Discomfort/Pain
MAUDE report 21515766 ↗InjuryFeb 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE BAKER GRADE 2 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 21346236 ↗InjuryDec 24, 2024Gel Leak; Material Rupture; Gel Leak; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-11578 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 21014486 ↗InjuryDec 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE WITH HEMATOMA POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Hematoma
MAUDE report 20845060 ↗InjuryDec 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE WITH HEMATOMA POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Hematoma
MAUDE report 20845030 ↗InjuryOct 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 20355295 ↗InjurySep 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DIAGNOSED THROUGH ULTRASOUND. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20136915 ↗InjurySep 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DIAGNOSED THROUGH ULTRASOUND. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20136899 ↗InjuryMay 24, 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 SURGERY WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS AS WELL AS FLUID COLLECTION IN HER RIGHT BREAST, WHICH WERE CONFIRMED VIA MAGNETIC RESONANCE IMAGING. THE PATIENT¿S RIGHT BREAST WAS REPORTED TO BE SWOLLEN. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO BE REIMPLANTED ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT.
Patient problems: Capsular Contracture
MAUDE report 19395446 ↗InjuryMay 24, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS AS WELL AS FLUID COLLECTION IN HER RIGHT BREAST, WHICH WERE CONFIRMED VIA MAGNETIC RESONANCE IMAGING. THE PATIENT¿S RIGHT BREAST WAS REPORTED TO BE SWOLLEN. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO BE REIMPLANTED ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 19395441 ↗InjuryMay 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS AND BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WERE CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-05356 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement; Local Reaction
MAUDE report 19261002 ↗InjuryMay 7, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS AND BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WERE CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-05355 FOR THE CONTRALATERAL EVENT.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 19260985 ↗InjuryApr 26, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT 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 19196858 ↗InjuryJan 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 18530641 ↗InjuryJan 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 18530515 ↗InjuryJan 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 18530416 ↗InjuryDec 26, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT(LEFT) AND AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS (RIGHT) EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture; Necrosis
MAUDE report 18394788 ↗
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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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