MENTOR MemoryGel Breast Implant 3505160BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Ultra High Profile Silicone Gel-Filled Breast Implant, 160cc |Smooth|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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317006855), received between May 24, 2019 and Nov 22, 2023 — classified as 4 injuries.
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 Problem2
- Material Rupture2
Patient problems
- Capsular Contracture3
- Impaired Healing2
- No Code Available2
- Pain2
- Scarring2
- Deformity/ Disfigurement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2023Adverse 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 IMPLANTATION OF A 160CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE LEFT BREAST AND RIGHT BREAST ASYMMETRY DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS ON OCTOBER 25, 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12516 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 18192724 ↗InjuryOct 23, 2023Adverse 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 IMPLANTATION OF A 160CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE LEFT BREAST DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.
Patient problems: Capsular Contracture
MAUDE report 17988446 ↗InjuryMay 24, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 160CC AND EXPERIENCED BILATERAL ISSUES INCLUDING OPEN WOUNDS, PAIN, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture; Impaired Healing; No Code Available; Pain; Scarring
MAUDE report 8641828 ↗InjuryMay 24, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 160CC AND EXPERIENCED BILATERAL ISSUES INCLUDING OPEN WOUNDS, PAIN, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.
Patient problems: Capsular Contracture; Impaired Healing; No Code Available; Pain; Scarring
MAUDE report 8641820 ↗
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- 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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