MENTOR MemoryGel Breast Implant 3544507Recalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Profile Gel-Filled Breast Implant, 450cc · 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 has 130 adverse event reports on record, with no deaths and 130 injuries. The reports mostly describe the implant rupturing, and some mention tightening of scar tissue around the implant (capsular contracture) or a change in breast shape. There are no recalls naming this device. The last 12 months show 3 reports, compared with 8 in the 12 months before.
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
- 130
- Deaths reported
- 0
- Injuries reported
- 130
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00081317000723), received between Mar 2, 2018 and Mar 17, 2026 — classified as 130 injuries.
The most frequently reported specific device problem is “Material Rupture” (96 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 Rupture96
- Adverse Event Without Identified Device or Use Problem41
- Migration4
- Gel Leak2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Code Available53
- Capsular Contracture44
- Deformity/ Disfigurement40
- Granuloma18
- Pain9
- Seroma4
- Autoimmune Reaction3
- Swollen Lymph Nodes3
Recent adverse event reports
The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24619542 ↗InjuryMar 17, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24619541 ↗InjuryMar 6, 2026Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2026, AND REPLACED WITH A 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24533493 ↗InjuryMar 21, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 450CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III-IV POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL CAPSULECTOMY AND REMOVAL ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21669577 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 450CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III-IV POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL CAPSULECTOMY AND REMOVAL ON (B)(6) 2025. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21669422 ↗InjuryMar 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21561244 ↗InjuryMar 7, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL 450CC SILICONE PROSTHESES EXPERIENCED A RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY, WHICH WAS EFFECTIVELY DIAGNOSED THROUGH BOTH MAMMOGRAM AND ULTRASOUND EXAMINATIONS. SURGICAL INTERVENTION HAS BEEN SCHEDULED FOR (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21551860 ↗InjuryFeb 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21313561 ↗InjuryJan 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 450CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.
Patient problems: Deformity/ Disfigurement
MAUDE report 21265794 ↗InjuryJan 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 450CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.
Patient problems: Deformity/ Disfigurement
MAUDE report 21265751 ↗InjuryDec 6, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 20870482 ↗InjuryOct 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE 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 20409591 ↗InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, SWOLLEN LYMPH NODES ON THE LEFT SIDE AND A RUPTURE AND GRANULOMA 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: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 20195730 ↗InjurySep 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, SWOLLEN LYMPH NODES ON THE LEFT SIDE AND A RUPTURE AND GRANULOMA 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: Capsular Contracture; Granuloma
MAUDE report 20195634 ↗InjuryJul 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19799313 ↗InjuryJul 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 450CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT NOTICED A LARGE LUMP UNDER THEIR RIGHT ARMPIT. AS A RESULT, THE PATIENT GOT AN ULTRASOUND, WHICH SHOWED A RUPTURED RIGHT BREAST IMPLANT. IN ADDITION, THE RIGHT BREAST HAS SAGGED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement; Granuloma
MAUDE report 19785674 ↗InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 450CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE EXAMINATIONS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH NON-MENTOR IMPLANTS. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 19515080 ↗InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 450CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE EXAMINATIONS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH NON-MENTOR IMPLANTS. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 19515004 ↗InjuryMay 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE WAS DIAGNOSED THROUGH MAMMOGRAPHY AND ULTRASOUND. THE RUPTURE WAS CONFIRMED DURING SURGERY. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. SEE 1645337-2024-05471 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Deformity/ Disfigurement
MAUDE report 19273188 ↗InjuryMay 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE WAS DIAGNOSED THROUGH MAMMOGRAPHY AND ULTRASOUND. THE RUPTURE WAS CONFIRMED DURING SURGERY. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. SEE 1645337-2024-05472 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Deformity/ Disfigurement
MAUDE report 19273179 ↗InjuryJan 24, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 450CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023, AND WAS REPLACED WITH A MENTOR GEL BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 18576514 ↗InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES NOTICED THAT HER BREAST PROSTHESES PULL ON THE SIDES, ¿FEEL WEIRD¿, AND ¿HANG FUNNY¿. 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: Deformity/ Disfigurement
MAUDE report 18337231 ↗InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES NOTICED THAT HER BREAST PROSTHESES PULL ON THE SIDES, ¿FEEL WEIRD¿, AND ¿HANG FUNNY¿. 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: Deformity/ Disfigurement
MAUDE report 18337228 ↗InjuryOct 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. THE ISSUES WERE DIAGNOSED VIA MAMMOGRAM, ULTRASOUND, AND MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH NON-MENTOR BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 17892629 ↗InjuryOct 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. THE ISSUES WERE DIAGNOSED VIA MAMMOGRAM, ULTRASOUND, AND MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH NON-MENTOR BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 17892628 ↗
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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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