MENTOR MemoryShape Breast Implant 3341254Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317024231), received between Nov 15, 2019 and Jan 22, 2026 — classified as 16 injuries, 1 malfunction.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 485CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS WAS OBSERVED TO HAVE SOMETHING THAT SPLATTERED ON IT WHEN OPENED PRIOR TO A BREAST SURGERY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153980 ↗
• InjuryDec 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 485CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE AND DISCOMFORT POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING. EXTRUDED SILICONE WAS NOTED NEAR THE VALVE. 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 21037086 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 485CC GEL BREAST PROSTHESES DEVELOPED ISSUES WITH IMPLANT PALPABILITY/VISIBILITY BILATERALLY POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT A BILATERAL CAPSULOTOMY AND CAPSULORRHAPHY (STAGED RECONSTRUCTION) ON (B)(6) 2021. AN ALLOGRAFT WAS PLACED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17742696 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 485CC GEL BREAST PROSTHESES DEVELOPED ISSUES WITH IMPLANT PALPABILITY/VISIBILITY BILATERALLY POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT A BILATERAL CAPSULOTOMY AND CAPSULORRHAPHY (STAGED RECONSTRUCTION) ON (B)(6) 2021. AN ALLOGRAFT WAS PLACED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17742695 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 485CC AND EXPERIENCED BILATERAL WRINKLING AND ASYMMETRY ON THE RIGHT SIDE POST-OPERATIVELY, WHICH REQUIRED FAT GRAFTING ON (B)(6) 2021. 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.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16062963 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 485CC AND EXPERIENCED BILATERAL WRINKLING AND ASYMMETRY ON THE RIGHT SIDE POST-OPERATIVELY, WHICH REQUIRED FAT GRAFTING ON (B)(6) 2021. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Deformity/ Disfigurement; Seroma; Wrinkling

  MAUDE report 16062962 ↗
• InjuryNov 15, 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 MNT-MEN-15-003: 326-055. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION PRIMARY SURGERY WITH 485CC MENTOR MEMORYSHAPE BREAST IMPLANT MENTOR GLOW STUDY GEL DEVICE ON (B)(6) 2020. ADVERSE EVENT # 1. INFECTION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2022; DATE OF EXPLANT: (B)(6) 2022). ON (B)(6) 2022, SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL, AND REPLACEMENT ON (B)(6) 2022. ADVERSE EVENT # 2. HEMATOMA, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2022). SURGERY WITH 430CC MENTOR MEMORYSHAPE BREAST IMPLANT MENTOR GLOW STUDY GEL DEVICE ON (B)(6) 2022. ON (B)(6) 2022, SHE PRESENTED WITH HEMATOMA, WHICH REQUIRED EVACUATION OF RIGHT BREAST HEMATOMA ON (B)(6) 2022. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE ADVERSE EVENT #1.

  Patient problems: Cancer; Post Operative Wound Infection

  MAUDE report 15799811 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 485CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITIES AND PTOSIS ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION VIA FAT GRAFTING TO TREAT. 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 15567389 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 485CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITIES AND PTOSIS ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION VIA FAT GRAFTING TO TREAT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 15567274 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 485CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A LOCAL REACTION ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT REPORTED THAT THE BREAST HAD TENDERNESS AND FLUID BUILDING AROUND THE BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 15433452 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 485CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST-OPERATIVELY. 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.

  Patient problems: Capsular Contracture

  MAUDE report 15175781 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYSHAPE BREAST, 485CC SILICONE PROSTHESIS, EXPERIENCED BILATERAL PROCEDURAL DISSATISFACTIONS POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXIES ON (B)(6) 2020. THE REPORT INDICATED THAT THE OUTCOME RESOLVED. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; No Clinical Signs, Symptoms or Conditions; Wrinkling

  MAUDE report 12050092 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYSHAPE BREAST, 485CC SILICONE PROSTHESIS, EXPERIENCED BILATERAL PROCEDURAL DISSATISFACTIONS POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTOPEXIES ON (B)(6) 2020. THE REPORT INDICATED THAT THE OUTCOME RESOLVED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; No Clinical Signs, Symptoms or Conditions; Wrinkling

  MAUDE report 12050048 ↗
• InjuryJun 5, 2021Migration; Migration

  THIS EVENT IS IN RELATION TO (B)(6) STUDY PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 485CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED RIPPLING, ASYMMETRY, IMPLANT MALPOSITION, HEMATOMA, AND EARLY ONSET SEROMA POST PROCEDURE. ON (B)(6) 2020, PATIENT UNDERWENT A SURGICAL INTERVENTION TO HAVE ACELLULAR DERMAL GRAFT PLACEMENT, FAT GRAFTING, FLAP RECONSTRUCTION TO ADDRESS THE RIPPLING, ASYMMETRY AND IMPLANT MALPOSITION. ON (B)(6) 2020, PATIENT HAD DRAINAGE AND ASPIRATION TO ADDRESS THE HEMATOMA. AS A RESULT OF THE EARLY ONSET SEROMA, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6)2021.

  Patient problems: Hematoma; Post Operative Wound Infection; Seroma; Wrinkling

  MAUDE report 11943796 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 485CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY, SURGICAL INTERVENTION, AND RIGHT-SIDED DEVICE EXTRUSION. DUE TO BILATERAL WRINKLING, THE PATIENT UNDERWENT A BILATERAL SURGICAL INTERVENTION ON (B)(6) 2020. IN ADDITION, THE PATIENT EXPERIENCED RIGHT-SIDED DEVICE EXTRUSION SOMETIME LATER. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL WITHOUT REPLACEMENT FOR THE RIGHT SIDE ON (B)(6) 2021. THE PATIENT¿S DATE OF BIRTH WAS ESTIMATED (B)(6) BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 11803423 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 485CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY, SURGICAL INTERVENTION, AND RIGHT-SIDED DEVICE EXTRUSION. DUE TO BILATERAL WRINKLING, THE PATIENT UNDERWENT A BILATERAL SURGICAL INTERVENTION ON (B)(6) 2020. IN ADDITION, THE PATIENT EXPERIENCED RIGHT-SIDED DEVICE EXTRUSION SOMETIME LATER. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL WITHOUT REPLACEMENT FOR THE RIGHT SIDE ON (B)(6) 2021. THE PATIENT¿S DATE OF BIRTH WAS ESTIMATED (B)(6) BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Pocket Erosion; Wrinkling

  MAUDE report 11803357 ↗
• InjuryNov 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 485CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. IN ADDITION, THE PATIENT HAS DEVELOPED SARCOMA. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: Cancer; No Code Available

  MAUDE report 9331655 ↗