MENTOR MemoryGel Breast Implant 3543007MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00081317004394), received between Nov 9, 2018 and Aug 27, 2025 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22906781 ↗
• InjuryJun 26, 2025Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND 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: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22340480 ↗
• InjuryJun 23, 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 AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III 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 22306836 ↗
• MalfunctionFeb 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PAIR OF 300CC MENTOR MEMORYGEL BREAST IMPLANTS WERE FOUND TO HAVE DAMAGE INDICATING POSSIBLE MALFUNCTION DURING ANALYSIS. THESE DEVICES WERE RETURNED TO EVALUATE A COSMETIC ISSUE (AIR BUBBLES WITHIN THE GEL). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337664 ↗
• MalfunctionFeb 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PAIR OF 300 CC MENTOR MEMORYGEL BREAST IMPLANTS WERE FOUND TO HAVE DAMAGE INDICATING POSSIBLE MALFUNCTION DURING ANALYSIS. THESE DEVICES WERE RETURNED TO EVALUATE A COSMETIC ISSUE (AIR BUBBLES WITHIN THE GEL). THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337657 ↗
• InjuryOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND 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) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20384436 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 320CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19659243 ↗
• InjuryMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 300CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON AN UNKNOWN DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19313927 ↗
• InjuryMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 300CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON AN UNKNOWN DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19313628 ↗
• InjuryMay 13, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERALLY ENLARGED LYMPH NODES WITH PAIN, THROBBING, AND DISCOMFORT. BIOPSIES WERE PERFORMED AND IT WAS DETERMINED THAT THE PATIENT DEVELOPED SILICONE LYMPHADENOPATHY IN BOTH ARMPITS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION AND EVENT WERE PROVIDED TO MENTOR AS A BEST ESTIMATE. MENTOR BECAME AWARE THAT A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. AS IMPLANT DATE AS PROVIDED AS AN APPROXIMATE DATE AND THEY DO NOT KNOW WHAT THE EXACT DATE WAS, FOR FURTHER FOLLOW-UPS ARE NECESSARY.

  Patient problems: Granuloma

  MAUDE report 19305735 ↗
• InjuryMay 13, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERALLY ENLARGED LYMPH NODES WITH PAIN, THROBBING, AND DISCOMFORT. BIOPSIES WERE PERFORMED AND IT WAS DETERMINED THAT THE PATIENT DEVELOPED SILICONE LYMPHADENOPATHY IN BOTH ARMPITS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION AND EVENT WERE PROVIDED TO MENTOR AS A BEST ESTIMATE. MENTOR BECAME AWARE THAT A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. AS IMPLANT DATE AS PROVIDED AS AN APPROXIMATE DATE AND THEY DO NOT KNOW WHAT THE EXACT DATE WAS, FOR FURTHER FOLLOW-UPS ARE NECESSARY.

  Patient problems: Granuloma

  MAUDE report 19305722 ↗
• InjuryJan 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 275CC ON THE LEFT, AND 300CC ON THE RIGHT SIDE, SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN IMPLANTS ON AN UNSPECIFIED DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18427046 ↗
• InjuryOct 11, 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 PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17917014 ↗
• InjuryAug 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM AND ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. THERE IS ALSO PRESENCE OF SILICONE IN THE PATIENT'S AXILLA. 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: Deformity/ Disfigurement

  MAUDE report 17608224 ↗
• InjuryAug 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM AND ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. THERE IS ALSO PRESENCE OF SILICONE IN THE PATIENT'S AXILLA. 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: Deformity/ Disfigurement

  MAUDE report 17608223 ↗
• InjuryMar 14, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 300CC SILICONE BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT LEFT SIDED CAPSULECTOMY AND CAPSULOTOMY, AND UNILATERAL REMOVAL WITH MENTOR 320ML CLASSIC SMOOTH ROUND MODERATE MEMORYGEL IMPLANT ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 16538557 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED BILATERAL MASTITIS 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 LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Unspecified Reproductive System or Breast Problem

  MAUDE report 15564338 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED BILATERAL MASTITIS 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 BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Unspecified Reproductive System or Breast Problem

  MAUDE report 15564250 ↗
• InjuryOct 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15546726 ↗
• InjuryOct 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15546611 ↗
• InjuryJun 14, 2022Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL SWELLING, DISCOMFORT, AND BREAST IMPLANT RUPTURE POSTOPERATIVELY; CONFIRMED VIA MRI. THE ISSUE WAS DIAGNOSED AFTER PHYSICAL. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2022. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Local Reaction

  MAUDE report 14683095 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL SWELLING, DISCOMFORT, AND BREAST IMPLANT RUPTURE POSTOPERATIVELY; CONFIRMED VIA MRI. THE ISSUE WAS DIAGNOSED AFTER PHYSICAL. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2022. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Local Reaction

  MAUDE report 14683092 ↗
• InjuryApr 8, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 300CC BREAST IMPLANT HAS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND BREAST PAIN POSTOPERATIVELY. THE PATIENT REPORTED BILATERAL RUPTURE & SHOOTING PAIN THROUGH THE BREASTS. THE ISSUE WAS CONFIRMED THROUGH ULTRASOUND & MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Capsular Contracture

  MAUDE report 14057903 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT (DATE OF IMPLANT: (B)(6) 2014) AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY GRANULOMA FORMATION IN THE RIGHT AXILLA REGION CONFIRMED BY BIOPSY PERFORMED DURING SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE; BAKER GRADE II ON THE LEFT, AND BAKER GRADE III ON THE RIGHT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED LATE ONSET SEROMA, THE FLUID WAS SENT FOR PATHOLOGY, AT THIS TIME, THE RESULTS OF THE PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH BILATERAL NEW SALINE IMPLANTS ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 13472411 ↗
• InjuryJan 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE AND CAPSULAR CONTRACTURE POST PROCEDURE. THE ISSUES WERE DIAGNOSED AT THE PHYSICIAN¿S OFFICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13405870 ↗