MENTOR MemoryShape Breast Implant 3341355Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00081317005353), received between Jul 29, 2019 and Apr 7, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESES IS VERY DISSATISFIED WITH THE AMOUNT OF WRINKLING ON HER BREASTS POST IMPLANTATION. 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: Wrinkling

  MAUDE report 24802290 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESES IS VERY DISSATISFIED WITH THE AMOUNT OF WRINKLING ON HER BREASTS POST IMPLANTATION. 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: Wrinkling

  MAUDE report 24802283 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT ALSO REPORTED SYMPTOMS INCLUDING BREAST IMPLANT ILLNESSES, AUTOIMMUNE ISSUES, NAPRAPATHY, FATIGUE, BREAST PAIN, COPD, INFLAMMATION, PAIN, HAIR LOSS, AND NAIL LOSS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 24792253 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND A 525CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2) POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED A RUPTURE ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24272044 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORY SHAPE BREAST IMPLANT 475CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER RIGHT BREAST POST IMPLANTATION. THERE WAS FLUID COMING OUT OF THE BREAST, RASH, REDNESS, AND SWELLING. THE INFECTION WAS DIAGNOSED VIA PATHOLOGY RESULTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22758579 ↗
• 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 CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE 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.

  Patient problems: Capsular Contracture

  MAUDE report 22307750 ↗
• 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 MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE 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.

  Patient problems: Capsular Contracture

  MAUDE report 22307567 ↗
• InjuryMar 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE AND A GRANULOMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 21526836 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MOTIVA BREAST IMPLANTS ON (B)(6) 2025. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 21507555 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 475 CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MOTIVA BREAST IMPLANTS ON (B)(6) 2025. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 21507549 ↗
• InjuryJan 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND BILATERALLY RUPTURED BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC (LEFT-SIDED) AND 525CC (RIGHT-SIDED) MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21120521 ↗
• InjuryJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST PAIN, DISCOMFORT, AND SWELLING. ULTRASOUND IMAGING WAS PERFORMED AND INDICATED A RUPTURED RIGHT BREAST IMPLANT WITH SIGNS OF RIGHT BREAST INFLAMMATION WITH FLUID BUILDUP. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH UNDISCLOSED BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Local Reaction

  MAUDE report 19580661 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CUTANEOUS CONTOUR DEFORMITY. 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: Wrinkling

  MAUDE report 18893824 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CUTANEOUS CONTOUR DEFORMITY. 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: Wrinkling

  MAUDE report 18893821 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18049668 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 475CC AND EXPERIENCED PATIENT DISSATISFACTION ON THE RIGHT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT UNDERWENT A POCKET ADJUSTMENT ON THE LEFT SIDE ON (B)(6) 2021. THE DEVICE WAS NOT EXPLANTED DURING THE PROCEDURE. THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON AN UNSPECIFIED DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2021-01370 FOR CONTRALATERAL SIDE.

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

  MAUDE report 18033965 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH A (LEFT) 475CC MENTOR MEMORYSHAPE BREAST IMPLANT AND A (RIGHT) 495CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CANCER. 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: Breast Cancer

  MAUDE report 17865321 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST MASSES POST PROCEDURE. AN UNSPECIFIED SURGICAL INTERVENTION WAS PERFORMED TO CORRECT THIS. 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 1645337-2023-08704 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Mass

  MAUDE report 17379470 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST MASSES POST PROCEDURE. AN UNSPECIFIED SURGICAL INTERVENTION WAS PERFORMED TO CORRECT THIS. 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 1645337-2023-08703 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Mass

  MAUDE report 17379469 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH DISSATISFACTION WITH APPEARANCE OF HER BREASTS. AS A RESULT, SHE UNDERWENT A SURGICAL INTERVENTION WHICH REQUIRED BILATERAL FAT GRAFTING. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02124 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16438510 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH DISSATISFACTION WITH APPEARANCE OF HER BREASTS. AS A RESULT, SHE UNDERWENT A SURGICAL INTERVENTION WHICH REQUIRED BILATERAL FAT GRAFTING. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02123 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16438508 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 475CC (RIGHT) AND A 555CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY. THE PATIENT WAS PRESENTED WITH WRINKLING WHICH REQUIRED FAT GRAFTING. 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 DEVICE.

  Patient problems: Wrinkling

  MAUDE report 15620823 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 475CC MENTOR MEMORYSHAPE BREAST IMPLANT GEL PROSTHESIS. POST-OPERATIVELY, THE PATIENT¿S RIGHT BREAST APPEARED LARGER THAN THE LEFT AND BOTH BREASTS WERE FIRM. UPON AN IN-OFFICE VISIT, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-07265 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 14760065 ↗
• InjuryJun 21, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 475CC MENTOR MEMORYSHAPE BREAST IMPLANT GEL PROSTHESIS. POST-OPERATIVELY, THE PATIENT¿S RIGHT BREAST APPEARED LARGER THAN THE LEFT AND BOTH BREASTS WERE FIRM. UPON AN IN-OFFICE VISIT, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST IMPLANT. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 14759953 ↗
• InjuryMay 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 475CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14271560 ↗