MENTOR MemoryShape Breast Implant 3341454Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317024279), received between Apr 15, 2021 and Mar 5, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Migration” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE, 755CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED SILENT RUPTURE, AND LEFT SIDED IMPLANT RIPPLING POST PROCEDURE. THE MRI EXAMINATION CONFIRMED THE RIGHT SIDED RUPTURE. THE PATIENT INDICATED THAT SHE HAS PAIN IN THE RIGHT SIDE, AND SOME RIPPLING ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: L/ SN: (B)(6), R/ SN: (B)(6) ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Wrinkling

  MAUDE report 24526547 ↗
• InjuryJul 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE AND A REACTION ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Granuloma; Local Reaction; Seroma

  MAUDE report 22384190 ↗
• InjuryDec 7, 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 IMPLANTATION PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18283833 ↗
• InjuryApr 13, 2023Migration; Migration

  [SAFETY_NOTE_2] SUBJECT ID:(B)(6). 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 # 6. WRINKLING, IMPLANT MALPOSITION,( LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2020). ON (B)(6) 2020 (B)(6) 2021, SHE PRESENTED WITH WRINKLING, IMPLANT MALPOSITION, WHICH REQUIRED POCKET ADJUSTMENT ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, NOT RELATED TO THE DEVICE, AND UNKNOWN RELATED TO THE PROCEDURE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16731907 ↗
• InjuryApr 13, 2023Migration; Migration

  ADVERSE EVENT # 5. WRINKLING, IMPLANT MALPOSITION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: (B)(6) 2020). ON (B)(6) 2021, SHE PRESENTED WITH WRINKLING, IMPLANT MALPOSITION, WHICH REQUIRED POCKET ADJUSTMENT ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, NOT RELATED TO THE DEVICE, AND UNKNOWN RELATED TO THE PROCEDURE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16731869 ↗
• InjuryOct 14, 2022Adverse 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

  THIS EVENT IS ASSOCIATED WITH THE MNT-MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (MENTOR GLOW STUDY GEL DEVICES) ON BOTH SIDES ON (B)(6) 2018, NEWLY DIAGNOSED RIGHT BREAST CANCER (RIGHT IMPLANT SERIAL NUMBER (B)(4). ON ,(B)(6) 2021, THE PATIENT REPORTED NEWLY DIAGNOSED RIGHT BREAST CANCER. THE PATIENT WAS HOSPITALIZED FOR ONE (1) DAY AND WAS TREATED WITH A CAPSULOTOMY. ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT-SIDED CAPSULOTOMY, SCAR REVISION SURGERY, AND POCKET ADJUSTMENT DUE TO CAPSULAR CONTRACTURE BAKER GRADE III AND NECROSIS. THE RIGHT-SIDE DEVICE WAS NOT EXPLANTED, AND A NEW DEVICE WAS NOT IMPLANTED. ON THE SAME DAY, THE PATIENT UNDERWENT LEFT-SIDED CAPSULOTOMY, POCKET ADJUSTMENT, AND SKIN ADJUSTMENT DUE TO CAPSULAR CONTRACTURE BAKER GRADE III AND ASYMMETRY. THE LEFT-SIDE DEVICE WAS NOT EXPLANTED, AND A NEW DEVICE WAS NOT IMPLANTED. DURING THE PATIENT¿S FIRST (1) YEAR FOLLOW-UP VISIT WAS PERFORMED ON (B)(6) 2020, THE SECOND (2) YEAR FOLLOW-UP VISIT WAS PERFORMED ON (B)(6) 2020, THE THIRD (3) YEAR FOLLOW-UP WAS PERFOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Cancer; Cancer; Capsular Contracture; Necrosis

  MAUDE report 15607813 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE MNT-MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(4). IT WAS REPORTED THAT A BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (MENTOR GLOW STUDY GEL DEVICES) ON BOTH SIDES ON (B)(6) 2018, NEWLY DIAGNOSED RIGHT BREAST CANCER (RIGHT IMPLANT SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE PATIENT REPORTED NEWLY DIAGNOSED RIGHT BREAST CANCER. THE PATIENT WAS HOSPITALIZED FOR ONE (1) DAY AND WAS TREATED WITH A CAPSULOTOMY. ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT-SIDED CAPSULOTOMY, SCAR REVISION SURGERY, AND POCKET ADJUSTMENT DUE TO CAPSULAR CONTRACTURE BAKER GRADE III AND NECROSIS. THE RIGHT-SIDE DEVICE WAS NOT EXPLANTED, AND A NEW DEVICE WAS NOT IMPLANTED. ON THE SAME DAY, THE PATIENT UNDERWENT LEFT-SIDED CAPSULOTOMY, POCKET ADJUSTMENT, AND SKIN ADJUSTMENT DUE TO CAPSULAR CONTRACTURE BAKER GRADE III AND ASYMMETRY. THE LEFT-SIDE DEVICE WAS NOT EXPLANTED, AND A NEW DEVICE WAS NOT IMPLANTED. DURING THE PATIENT¿S FIRST (1) YEAR FOLLOW-UP VISIT WAS PERFORMED ON (B)(6) 2020, THE SECOND (2) YEAR FOLLOW-UP VISIT WAS PERFORMED ON (B)(6) 2020, THE THIRD (3) YEAR FOLLOW-UP WAS PERFOR

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

  MAUDE report 15607804 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 755CC AND UNDERWENT A FAT GRAFTING PROCEDURE ON THE LEFT SIDE. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15582808 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT # 6. WRINKLING, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2020). ON (B)(6) 2021, SHE PRESENTED WITH WRINKLING, WHICH REQUIRED SURGICAL INTERVENTION, FAT GRAFTING ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Post Operative Wound Infection; Wrinkling

  MAUDE report 13453345 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT # 5. WRINKLING, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2020). ON (B)(6) 2021, SHE PRESENTED WITH WRINKLING, WHICH REQUIRED SURGICAL INTERVENTION, FAT GRAFTING (B)(6) 2021.THE DEVICE WAS EXPLANTED ON (B)(6) 2021. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Bacterial Infection; Post Operative Wound Infection; Wrinkling

  MAUDE report 13453229 ↗
• InjuryJun 23, 2021Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN UNKNOWN MENTOR BREAST IMPLANT AND SUFFERED FROM A CUTANEOUS CONTOUR DEFORMITY, SURGICAL INTERVENTION, DEVICE MIGRATION ON THE LEFT SIDE. THE TYPE OF THE DEVICE INVOLVED IS UNKNOWN. THE COMMON DEVICE NAME AND PROCODE VALUES ARE BEING USED FOR SUBMISSION PURPOSES ONLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 12051553 ↗
• InjuryJun 23, 2021Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN UNKNOWN MENTOR BREAST IMPLANT AND SUFFERED FROM A CUTANEOUS CONTOUR DEFORMITY, SURGICAL INTERVENTION, DEVICE MIGRATION ON THE RIGHT SIDE. THE TYPE OF THE DEVICE INVOLVED IS UNKNOWN. THE COMMON DEVICE NAME AND PROCODE VALUES ARE BEING USED FOR SUBMISSION PURPOSES ONLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 12051492 ↗
• InjuryApr 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION AS PART OF A CLINICAL STUDY WITH TWO 755CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON (B)(6) 2020, SUFFERED BILATERAL BREAST INFECTIONS, POST-PROCEDURE. THE ONSET OF THE RIGHT INFECTION WAS ON (B)(6) 2020 AND THE LEFT SIDE INFECTION WAS ON (B)(6) 2020. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANATION OF THE RIGHT DEVICE ON (B)(6) 2020 AND REPLACEMENT WITH A 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG: 3341454 LOT: 9409188 SN: (B)(4)) ON (B)(6) 2020. THE LEFT SIDE IMPLANT WAS REMOVED ON (B)(6) 2020 AND REPLACED WITH A 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG: 3341454 LOT: 9441651 SN: (B)(4)) ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11721503 ↗
• InjuryApr 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION AS PART OF A CLINICAL STUDY WITH TWO 755CC MENTOR MEMORYSHAPE BREAST IMPLANTS ON (B)(6) 2020, SUFFERED BILATERAL BREAST INFECTIONS, POST-PROCEDURE. THE ONSET OF THE RIGHT INFECTION WAS ON (B)(6) 2020 AND THE LEFT SIDE INFECTION WAS ON (B)(6) 2020. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANATION OF THE RIGHT DEVICE ON (B)(6) 2020 AND REPLACEMENT WITH A 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG: 3341454 LOT: 9409188 SN: (B)(4)) ON (B)(6) 2020. THE LEFT SIDE IMPLANT WAS REMOVED ON (B)(6) 2020 AND REPLACED WITH A 755CC MENTOR MEMORYSHAPE BREAST IMPLANT (CATALOG: 3341454 LOT: 9441651 SN: (B)(4)) ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11721502 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 755CC. MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED DELAYED WOUND HEALING POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON A (B)(6) 2020.

  Patient problems: Impaired Healing

  MAUDE report 11676244 ↗