MENTOR MemoryShape Breast Implant 3341105Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00081317005308), received between Feb 22, 2021 and Sep 10, 2026 — classified as 23 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse 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 surgery with a 255cc MENTOR MemoryShape Breast Implant and experienced cutaneous contour deformity (wrinkling) on the right side post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Wrinkling

  MAUDE report 50717884 ↗
• InjurySep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22953290 ↗
• InjuryJul 10, 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 BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESIS DEVELOPED PAIN 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: Breast Discomfort/Pain

  MAUDE report 22472228 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BREAST IMPLANT ILLNESS. THE PATIENT SYMPTOMS WERE FATIGUE, BRAIN FOG, AND NAUSEA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 22470436 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORY SHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BREAST IMPLANT ILLNESS. THE PATIENT SYMPTOMS WERE FATIGUE, BRAIN FOG, AND NAUSEA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 22470435 ↗
• InjuryJul 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT SIDE, AND WITH 255CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. 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-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19803462 ↗
• InjuryJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE, 255CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19629762 ↗
• InjuryApr 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19192827 ↗
• InjuryApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE, 255CC, SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SILENT RUPTURE POST PROCEDURE. THE MRI EXAMINATIONS CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19116280 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RIGHT SIDED BREAST LUMP WITH A BURNING SENSATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass; Neuropathy

  MAUDE report 19111135 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DISSATISFIED WITH THE APPEARANCE OF HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED BREAST IMPLANTS ON AN APPROXIMATE REMOVAL DATE OF (B)(6) 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-04302 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 19076468 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DISSATISFIED WITH THE APPEARANCE OF HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED BREAST IMPLANTS ON AN APPROXIMATE REMOVAL DATE OF (B)(6), 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-04301 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 19076465 ↗
• InjuryMar 1, 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 255CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RHEUMATOID ARTHRITIS, JOINT STIFFNESS, PAIN, JOINT SWELLING, FATIGUE, SKIN BREAKOUTS, DRY EYES, DRY MOUTH, VISUAL ISSUES, COGNITIVE ISSUES POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18822168 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 255CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RHEUMATOID ARTHRITIS, JOINT STIFFNESS, PAIN, JOINT SWELLING, FATIGUE, SKIN BREAKOUTS, DRY EYES, DRY MOUTH, VISUAL ISSUES, COGNITIVE ISSUES POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18822090 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 225CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16881774 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 270CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT¿S RIGHT BREAST PROSTHESIS ROTATED. 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: Breast Discomfort/Pain; Capsular Contracture; Wrinkling

  MAUDE report 16717908 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 255CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED BILATERAL BREAST PAIN, POST-OPERATIVELY. 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: Breast Discomfort/Pain

  MAUDE report 16696025 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 255CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED BILATERAL BREAST PAIN, POST-OPERATIVELY. 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 Discomfort/Pain

  MAUDE report 16696024 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 255CC MENTOR MEMORYSHAPE BREAST IMPLANT WAS FOUND TO BE RUPTURED PRIOR TO PLACEMENT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE USING A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14857249 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13344829 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD ASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13344778 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. THE PATIENT FIRST NOTICED THAT THERE WAS RIPPLING ON HER BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS LATER DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13162947 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 255CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. THE PATIENT FIRST NOTICED THAT THERE WAS RIPPLING ON HER BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS LATER DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13162533 ↗
• InjuryFeb 22, 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 MIXED-RACE (CAUCASIAN, HISPANIC/LATINO) FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 255CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED CUTANEOUS CONTOUR DEFORMITY. THE PATIENT STATED THAT HER LEFT BREAST SHOWS AN INDENTATION AND PUCKERING WHEN SHE LIFTS UP HER LEFT ARM. THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 11362752 ↗