MENTOR MemoryShape Breast Implant 3341052Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317005179), received between May 14, 2019 and Jan 23, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Adverse 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 260CC MENTOR MEMORYSHAPE BREAST IMPLANT. DURING THE 10 YEAR FOLLOW-UP VISIT, THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME; THE PATIENT SUFFERERED DUE TO BREAST DISCOMFORT AND ASYMMETRY ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 21225937 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE, 260CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE IV POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20591909 ↗
• InjuryMar 30, 2023Migration; Migration

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 260CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING OF THE RIGHT PERI AREOLAR INCISION WHICH THEN SUBSEQUENTLY REQUIRED A FAT GRAFTING PROCEDURE DUE TO AN UNDISCLOSED REASON. CURRENTLY, BOTH IMPLANTS HAVE ROTATED FROM THEIR ORIGINAL POSITIONS AND SHE WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03764 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement; Impaired Healing

  MAUDE report 16652095 ↗
• InjuryNov 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR OLD WHITE FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 260CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED A SWOLLEN, TENDER, AND PAINFUL LEFT AXILLARY SOFT TISSUE MASS, THAT LIMITED HER ARM MOVEMENTS. AS A RESULT, THE PATIENT UNDERWENT AN EXCISION OF THE AXILLARY SOFT TISSUE MASS ON (B)(6) 2022. THE PATIENT HAD BIOPSY DONE. IN ADDITION, THE PATIENT ALSO HAD MAMMOGRAMS AND CT SCAN THAT DID NOT SUGGEST ANY RUPTURE. HOWEVER, THEY BELIEVE THAT THE IMPLANTS MUST BE RUPTURED DUE TO THE PATHOLOGY SHOWING SILICONE ADENOPATHY. 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: Deformity/ Disfigurement

  MAUDE report 15720594 ↗
• InjuryNov 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR OLD WHITE FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 260CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED A SWOLLEN, TENDER, AND PAINFUL LEFT AXILLARY SOFT TISSUE MASS, THAT LIMITED HER ARM MOVEMENTS. AS A RESULT, THE PATIENT UNDERWENT AN EXCISION OF THE AXILLARY SOFT TISSUE MASS ON (B)(6) 2022. THE PATIENT HAD BIOPSY DONE. IN ADDITION, THE PATIENT ALSO HAD MAMMOGRAMS AND CT SCAN THAT DID NOT SUGGEST ANY RUPTURE. HOWEVER, THEY BELIEVE THAT THE IMPLANTS MUST BE RUPTURED DUE TO THE PATHOLOGY SHOWING SILICONE ADENOPATHY. 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: Granuloma

  MAUDE report 15720149 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 260CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15401230 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 260CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED LUMPS AND UNSPECIFIED DEFORMITIES ON BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL BREAST PAIN. IT WAS ALSO REPORTED THAT THE PATIENT¿S RIGHT BREAST PROSTHESIS FLIPPED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 15294651 ↗
• InjuryMar 3, 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORY SHAPE BREAST IMPLANT 260CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT 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 13662291 ↗
• InjuryMay 14, 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 WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 260CC MENTOR MEMORYSHAPE BREAST IMPLANT DISCOVERED A LUMP ON THE LEFT BREAST POST PROCEDURE. THE LUMP WAS FOUND THROUGH AN ULTRASOUND. THE PATIENT STATED THEY PLANNED TO MEET WITH A SURGEON, HOWEVER, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 8608769 ↗