MENTOR MemoryShape Breast Implant 3341304Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317024248), received between May 5, 2021 and Jun 23, 2025 — classified as 14 injuries.

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.

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 545CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL ASYMMETRY 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 22309105 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 545CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL ASYMMETRY 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 22309104 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE (B)(4) CLINICAL TRIAL, PARTICIPANT (B)(4). IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 545CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A DEVICE EXTRUSION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Pocket Erosion

  MAUDE report 17145247 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 545CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 16055810 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 545CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 16054645 ↗
• InjurySep 8, 2021Adverse 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 WHO HAD 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS PLACED EXPERIENCED HYPERSENSITIVITY BILATERALLY POST PROCEDURE. THERE WAS A RASH. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-10039 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12443917 ↗
• InjurySep 8, 2021Adverse 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 WHO HAD 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS PLACED EXPERIENCED HYPERSENSITIVITY BILATERALLY POST PROCEDURE. THERE WAS A RASH. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-10040 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12443915 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL WRINKLING POST PROCEDURE. FAT GRAFTING WAS PERFORMED TO CORRECT THIS BILATERALLY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A CLINICAL STUDY. SEE 1645337-2021-07147 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Wrinkling

  MAUDE report 12054095 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL WRINKLING POST PROCEDURE. FAT GRAFTING WAS PERFORMED TO CORRECT THIS BILATERALLY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A CLINICAL STUDY. SEE 1645337-2021-07148 FOR CONTRALERAL PROSTHESIS REPORT.

  Patient problems: Wrinkling

  MAUDE report 12054090 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2020 . ADVERSE EVENT # 1. INFECTION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2020 , DATE OF EXPLANT: (B)(6) 2020 ). ON (B)(6) 2020 , SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL . THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND RELATED TO THE PROCEDURE. THE DEVICE WAS REPLACED WITH CAT#: 3505004BC, SN#: (B)(4). ADVERSE EVENT # 2. INFECTION, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2020 , DATE OF EXPLANT: (B)(6) 2020. ON (B)(6) 2020 , SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL . THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND RELATED TO THE PROCEDURE. THE DEVICE WAS REPLACED WITH CAT#: 3505004BC, SN#:(B)(4). SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND CASE REASSESSED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11924684 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2020. ADVERSE EVENT # 1. INFECTION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2020, DOE: (B)(6) 2020). ON (B)(6) 2020, SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL . THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND RELATED TO THE PROCEDURE. THE DEVICE WAS REPLACED WITH CAT#: 3505004BC, SN#: (B)(4). ADVERSE EVENT # 2. INFECTION, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2020, DOE: (B)(6) 2020. ON (B)(6) 2020, SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL . THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND RELATED TO THE PROCEDURE. THE DEVICE WAS REPLACED WITH CAT#: 3505004BC, SN#: (B)(4). SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND CASE REASSESSED. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11924611 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RIGHT-SIDED ANISOMASTIA AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POSTOPERATIVELY. THE PATIENT EXPRESSED DISSATISFACTION WITH ASYMMETRY AND WRINKLING OF THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS, 610CC ON THE LEFT (LEFT CATALOG # 3341354 AND LOT-SERIAL # (B)(4)) AND 680CC ON THE RIGHT (CATALOG # 3341404 AND LOT-SERIAL # (B)(4)) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 11788275 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 545CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RIGHT-SIDED ANISOMASTIA AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POSTOPERATIVELY. THE PATIENT EXPRESSED DISSATISFACTION WITH ASYMMETRY AND WRINKLING OF THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS, 610CC ON THE LEFT (LEFT CATALOG # 3341354 AND LOT-SERIAL # (B)(4)) AND 680CC ON THE RIGHT (CATALOG # 3341404 AND LOT-SERIAL # (B)(4)) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 11788274 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(4). IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 545CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED IMPAIRED HEALING ON THE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Impaired Healing

  MAUDE report 11777994 ↗