MENTOR MemoryGel Breast Implant 3545400Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317007142), received between Jun 13, 2019 and Sep 17, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST PAIN AND CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23076879 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 405CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 425CC GEL BREAST PROSTHESIS ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23057023 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 405CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 425CC GEL BREAST PROSTHESIS ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23056970 ↗
• InjurySep 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A CT SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20252026 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19101508 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19101432 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 400CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 375CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 365CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A RIGHT-SIDED 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6), 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02846 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16530090 ↗
• InjuryDec 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 400CC SILICONE BREAST PROSTHESIS EXPERIENCED BILATERAL, BREAST MASS, BREAST PAIN AND RIGHT-SIDED LYMPHADENOPATHY, AND SYMPTOMATIC RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND AND MAMMOGRAM EXAMINATIONS. THE ULTRASOUNDS RESULT STATED THAT THE MULTIPLE ENLARGED LYMPH NODES IN RIGHT AXILLARY TAIL ARE BENIGN. BIOPSY WAS CANCELLED DUE TO BENIGN NATURE OF FINDINGS. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 16051185 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 400CC SILICONE BREAST PROSTHESIS EXPERIENCED BILATERAL, BREAST MASS, BREAST PAIN AND RIGHT-SIDED LYMPHADENOPATHY, AND SYMPTOMATIC RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND AND MAMMOGRAM EXAMINATIONS. THE ULTRASOUNDS RESULT STATED THAT THE MULTIPLE ENLARGED LYMPH NODES IN RIGHT AXILLARY TAIL ARE BENIGN. BIOPSY WAS CANCELLED DUE TO BENIGN NATURE OF FINDINGS. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 16051144 ↗
• InjuryFeb 11, 2020Adverse 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 A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC AND EXPERIENCED BILATERAL HEMATOMA AND BILATERAL INFECTION. DRAINS WERE PLACED AND WERE REMOVED ON (B)(6) 2020. FLUID WAS ASPIRATED ON (B)(6) 2020. THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6)2020. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 9694149 ↗
• InjuryFeb 11, 2020Adverse 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 A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC AND EXPERIENCED BILATERAL HEMATOMA AND BILATERAL INFECTION. DRAINS WERE PLACED AND WERE REMOVED ON (B)(6) 2020. FLUID WAS ASPIRATED ON (B)(6) 2020. THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 9694134 ↗
• InjuryJul 26, 2019Adverse 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 A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC AND EXPERIENCED RIPPLING ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available; Wrinkling

  MAUDE report 8832758 ↗
• InjuryJun 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC AND EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE (BAKER GRADE III) AND A POSSIBLE RUPTURE ON THE LEFT SIDE IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8698069 ↗
• InjuryJun 13, 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 FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC AND EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE (BAKER GRADE III) AND A POSSIBLE RUPTURE ON THE LEFT SIDE IMPLANT. 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 IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 8698066 ↗