MENTOR MemoryGel Breast Implant 3544350Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00081317001065), received between Feb 9, 2018 and Sep 9, 2026 — classified as 94 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (54 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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Material Rupture

  Patient problems: Breast Discomfort/Pain

  MAUDE report 50702259 ↗
• InjurySep 9, 2026Material Rupture

  Patient problems: Breast Discomfort/Pain

  MAUDE report 50702258 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24337219 ↗
• InjuryFeb 5, 2026Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24269576 ↗
• InjuryDec 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT AND 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 23831616 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH GRANULOMA AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23620322 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 23286495 ↗
• MalfunctionAug 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BREAST IMPLANT WAS FOUND TO BE DEFLATED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727929 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22574389 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS, DEVELOPED RIGHT BREAST MRSA INFECTION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON AN UNSPECIFIED DATE. THE REPLACEMENT DEVICE WAS A MENTOR SALINE IMPLANT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22199886 ↗
• InjuryApr 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21886969 ↗
• InjuryApr 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21886968 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. INITIALLY, NO BAKER GRADE LEVEL WAS PROVIDED FOR THE CAPSULAR CONTRACTURE. AFTER FOLLOW-UP ATTEMPTS, IT WAS REPORTED THAT THE PATIENT HAD BAKER GRADE LEVEL 1 ON BOTH SIDES. CAPSULAR CONTRACTURE WITH BAKER GRADE 1 IS NOT CLINICALLY SIGNIFICANT AS IT IS AN EXPECTED PHYSIOLOGICAL REACTION HOWEVER, SINCE THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024, THIS EVENT WILL BE CONSERVATIVELY REPORTED. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637167 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. INITIALLY, NO BAKER GRADE LEVEL WAS PROVIDED FOR THE CAPSULAR CONTRACTURE. AFTER FOLLOW-UP ATTEMPTS, IT WAS REPORTED THAT THE PATIENT HAD BAKER GRADE LEVEL 1 ON BOTH SIDES. CAPSULAR CONTRACTURE WITH BAKER GRADE 1 IS NOT CLINICALLY SIGNIFICANT AS IT IS AN EXPECTED PHYSIOLOGICAL REACTION HOWEVER, SINCE THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024, THIS EVENT WILL BE CONSERVATIVELY REPORTED. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636598 ↗
• InjuryNov 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION 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. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20599678 ↗
• InjuryOct 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH UNSPECIFIED MENTOR BREAST PROSTHESIS EXPERIENCED A RUPTURE 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 20429243 ↗
• InjuryOct 10, 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 PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL AND USING ULTRASOUND AND MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418505 ↗
• InjurySep 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND RUPTURE ON THE RIGHT SIDE CONFIRMED BY ULTRASOUND AND COMPLICATED BY GRANULOMA FORMATIONS IN THE RIGHT AXILLA REGION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Granuloma

  MAUDE report 20334084 ↗
• InjuryAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. THE PATIENT NOTICED THAT HER BREASTS APPEARED ¿ENGORGED¿ AND ¿LUMPY¿. ADDITIONALLY, THE PATIENT FELT PAIN IN BOTH BREASTS. AS A RESULT, THE PATIENT HAD AN ULTRASOUND AND AN MRI PERFORMED. BOTH ULTRASOUND AND MRI DIAGNOSED BILATERAL BREAST PROSTHESIS RUPTURE. 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; Local Reaction

  MAUDE report 19951083 ↗
• InjuryAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. THE PATIENT NOTICED THAT HER BREASTS APPEARED ¿ENGORGED¿ AND ¿LUMPY¿. ADDITIONALLY, THE PATIENT FELT PAIN IN BOTH BREASTS. AS A RESULT, THE PATIENT HAD AN ULTRASOUND AND AN MRI PERFORMED. BOTH ULTRASOUND AND MRI DIAGNOSED BILATERAL BREAST PROSTHESIS RUPTURE. 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; Local Reaction

  MAUDE report 19951069 ↗
• InjuryJun 3, 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 PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT, 350CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED WOUND INFECTION, EARLY ONSET OF SEROMA, AND DEVICE EXTRUSION POST-OPERATION. THE REPORT STATED THAT THE SEROMA STARTED AFTER A MONTH OF IMPLANTATION. AS A RESULT, PATIENT UNDERWENT BILATERAL PROSTHESIS REMOVAL ON (B)(6) 2024.

  Patient problems: Pocket Erosion; Post Operative Wound Infection; Seroma

  MAUDE report 19454703 ↗
• MalfunctionMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A PRIMARY BREAST AUGMENTATION SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377222 ↗
• InjuryMay 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED BILATERAL DEFLATION 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 1645337-2024-05431 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19270221 ↗
• InjuryMay 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC AND EXPERIENCED BILATERAL DEFLATION 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 1645337-2024-05433 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19270211 ↗
• MalfunctionApr 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BREAST IMPLANTS 350CC BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THE CONTRALATERAL DEVICE WAS ALSO RUPTURED. SEE MANUFACTURER REPORT NUMBER 1645337-2024-04327 FOR CONTRALATERAL SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081107 ↗