MENTOR MemoryGel Breast Implant 3542157MCRecalls & reported problems
Mentor Texas L.P. · SILTEX Round Moderate Classic Profile Gel-Filled Breast Implant, 215cc |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
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317004356), received between Aug 20, 2019 and Dec 10, 2024 — classified as 12 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 Problem5
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Deformity/ Disfigurement7
- No Code Available3
- Pain2
- Seroma2
- Capsular Contracture1
- Granuloma1
- No Clinical Signs, Symptoms or Conditions1
- Swollen Lymph Nodes1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 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 SURGERY WITH IMPLANTATION OF A 215CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY SILICONE GRANULOMA FORMATION ON THE RIGHT SIDE CONFIRMED BY BIOPSY. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREASTS PTOSIS/ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement; Seroma
MAUDE report 20898553 ↗InjuryAug 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 215CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY SILICONE GRANULOMA FORMATION ON THE RIGHT SIDE CONFIRMED BY BIOPSY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024 .
Patient problems: Deformity/ Disfigurement; Granuloma; Seroma
MAUDE report 19975789 ↗InjuryApr 29, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 215CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-05093 FOR CONTRALATERAL SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19209388 ↗InjuryApr 29, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 215CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-05091 FOR CONTRALATERAL SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19209372 ↗InjurySep 18, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO HAD 215CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6), 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17765607 ↗InjurySep 18, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO HAD 215CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 17765552 ↗InjuryMay 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT AND PROPHYLACTICALLY REMOVED THE BREAST PROSTHESIS ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16872206 ↗InjuryApr 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DISCOVERED DURING EXPLANTATION SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 16715735 ↗InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 215CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL PAIN AND DISCOMFORT ON AN UNKNOWN DATE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-11462 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: No Code Available; Pain
MAUDE report 10525247 ↗InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 215CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL PAIN AND DISCOMFORT ON AN UNKNOWN DATE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-11461 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: No Code Available; Pain
MAUDE report 10525167 ↗InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 215CC AND EXPERIENCED RIGHT CONTOUR DEFORMITY. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2019.
Patient problems: No Code Available; Wrinkling
MAUDE report 9794112 ↗InjuryAug 20, 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANT 215CC (LEFT) AND MENTOR MEMORYGEL BREAST IMPLANT 300CC (RIGHT) AND EXPERIENCED BILATERAL SWOLLEN LYMPH NODES 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: Swollen Lymph Nodes
MAUDE report 8913423 ↗
Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices
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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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