MENTOR MemoryGel Breast Implant 3544425Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00081317001096), received between Jun 12, 2018 and Jan 15, 2026 — classified as 71 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (35 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE RUPTURE WAS DIAGNOSED VIA MRI AND ULTRASOUND. ADDTIONALLY, THE PATIENT DEVELOPED A LUMP ON HER RIGHT BREAST AND IS CONCERNED ABOUT CANCER. THE PATIENT INTENDS TO GET TESTING DONE TO DETERMINE WHAT THE LUMP IS. 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 24085365 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE RUPTURE WAS DIAGNOSED VIA MRI AND ULTRASOUND. ADDTIONALLY, THE PATIENT DEVELOPED A LUMP ON HER RIGHT BREAST AND IS CONCERNED ABOUT CANCER. THE PATIENT INTENDS TO GET TESTING DONE TO DETERMINE WHAT THE LUMP IS. 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: Breast Mass

  MAUDE report 24085353 ↗
• InjuryJan 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. POSSIBLE RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24046167 ↗
• InjuryOct 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING PAIN AND SWELLING OF THE RIGHT BREAST WITH A LEAKING RIGHT IMPLANT. MAGNETIC RESONANCE IMAGING WAS CONDUCTED AND RESULTS INDICATED FLUID ACCUMULATION IN THE RIGHT ARMPIT/PECTORALIS AREA. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE PENDING. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Local Reaction

  MAUDE report 23416669 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST AND HAD AN ULTRASOUND PERFORMED THAT DIAGNOSED POSSIBLE RUPTURE. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Granuloma

  MAUDE report 22374179 ↗
• InjuryApr 1, 2025Adverse 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 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21742510 ↗
• InjuryFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Deformity/ Disfigurement; Granuloma; Seroma

  MAUDE report 21334301 ↗
• InjuryOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20401638 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS DEVELOPED SORENESS AND TIGHTNESS IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT¿S LEFT BREAST APPEARS LARGER THAN THE RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 20078574 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANTS THAT WERE FOLDED, BUMPED, LUMPED AND CAUSING PAIN AND BURNING. THE RIGHT BREAST HAS A BIG BUMP ON THE SIDE AND BOTH BREAST FELT REALLY NASTY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 20054789 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANTS THAT WERE FOLDED, BUMPED, LUMPED AND CAUSING PAIN AND BURNING. THE RIGHT BREAST HAS A BIG BUMP ON THE SIDE AND BOTH BREAST FELT REALLY NASTY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 20043496 ↗
• InjuryJul 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 425CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED SILENT RUPTURE POST PLANTATION. THE MAMMOGRAM EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19776590 ↗
• InjuryApr 18, 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 IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THE IMPLANT INFORMATION WAS PROVIDED FOR BOTH BREAST PROSTHESES; HOWEVER, IT IS UNCLEAR WHICH IS THE IMPACTED PRODUCT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT COMPLAINT DEVICE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 19138386 ↗
• InjuryJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18437491 ↗
• InjuryNov 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND A GRANULOMA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Granuloma

  MAUDE report 18193858 ↗
• InjuryOct 6, 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 BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESES DEVELOPED BILATERAL CAPSULAR CONTRACTURE POST IMPLANTATION (BAKER GRADE III IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). IT WAS REPORTED THAT THE PATIENT HAS A LOT OF PAIN IN HER RIGHT BREAST. NO DISCOMFORT WAS REPORTED FOR THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT OF THE RIGHT BREAST PROSTHESIS ON (B)(6) 2023. THE EXPLANTED BREAST PROSTHESIS WAS REPLACED WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2019-19715 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17887530 ↗
• InjuryMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. COMPUTERIZED TOMOGRAPHY WAS PERFORMED TO EVALUATE A NODULE. THE COMPUTERIZED TOMOGRAPHY SCAN REVEALED THAT NODULE WAS AN IMPLANT RUPTURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16950489 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 16057619 ↗
• InjuryOct 19, 2022Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBERS (B)(4) RESPECTIVELY. IT WAS ALSO REPORTED VIA USER FACILITY REPORT NUMBER (B)(4). IT WAS REPORTED THAT A 53-YEAR-OLD, CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 425CC SILICONE BREAST PROSTHESIS DEVELOPED BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE, LEFT- SIDED RUPTURE, AND RIGHT-SIDED PARESTHESIA, AND SKIN REACTION POSTOPERATIVELY. THE PATIENT REPORTED THAT SHE IS EXPERIENCING ITCH AND NUMBNESS ON HER RIGHT SIDE IMPLANT AND HER ARM HURTS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED IMPLANTS ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS. NOTE: PATIENT PREVIOUS EVENT: REPORTED IN MANUFACTURER REPORT NUMBER 1645337-2020-10130.

  Patient problems: Capsular Contracture

  MAUDE report 15633359 ↗
• InjuryOct 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE BREAST IMPLANT RUPTURE, PAIN, AND BURNING SENSATION POSTOPERATIVELY. ULTRASOUND SHOWED RIGHT SIDE RUPTURE. MAMMOGRAM SCAN WAS ALSO TAKEN. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Paresthesia

  MAUDE report 15583861 ↗
• InjuryOct 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A 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 15552207 ↗
• InjuryAug 2, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD FEMALE WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 425CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POST PROCEDURE. AN OFFICE VISITATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15148420 ↗
• InjuryAug 2, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD FEMALE WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 425 CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POST PROCEDURE. AN OFFICE VISITATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15148386 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH TWO 425CC MENTOR MEMORYGEL TEXTURED BREAST IMPLANTS EXPERIENCED BILATERAL GRADE 3-4 CAPSULAR CONTRACTURE POSTOPERATIVELY, WITH EXTRACAPSULAR RUPTURE OF THE RIGHT BREAST. THE ISSUES WERE DIAGNOSED VIA ULTRASOUND AND MAMMOGRAM. AS A RESULT, THE PATIENT HAD BOTH DEVICES EXPLANTED AND REPLACED WITH SIMILAR, SMOOTH 425CC MENTOR GEL DEVICES ON (B)(6) 2022. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 14698757 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED HASHIMOTO¿S, HYPOTHYROID, FIBROMYALGIA, BREAST IMPLANT ILLNESS, EXTREMELY FATIGUE, ABNORMAL BLOODWORK, INFLAMMATION, PAIN, RASHES, HAIR LOSS, LOWER BACK PAIN AND MIGRAINES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 14504766 ↗