MENTOR MemoryGel Breast Implant 3545535Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317007180), received between Oct 14, 2019 and May 27, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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.

• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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 22088718 ↗
• InjuryMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22088657 ↗
• InjuryMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 535CC AND EXPERIENCED RUPTURE 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: Deformity/ Disfigurement

  MAUDE report 21505426 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19302788 ↗
• InjuryMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A POSSIBLE RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT NOTICED THAT THE BREAST WAS GETTING SMALLER AND HAD LUMP. IN ADDITION, THE PATIENT ALSO INFORMED OF RIPPLING UNDERNEATH THE BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 19234418 ↗
• InjuryDec 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN PERSON, WITH POSSIBLE LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18283036 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III/IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED PERI-IMPLANT FLUID IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2023. PATHOLOGY AND CYTOLOGY REPORTS WERE REQUESTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 16492098 ↗
• InjuryNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 535CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2022. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15730287 ↗
• InjuryJul 28, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 61-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT REPORTED THAT AFTER "AGGRESSIVE" MAMMOGRAMS ON (B)(6) 2022, HER IMPLANTS WERE DISPLACED AND LOPSIDED. THE LEFT BREAST IMPLANT RUPTURE WAS IDENTIFIED ON (B)(6) 2022 THROUGH MRI. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE BAKER GRADE 4 AND RIGHT BREAST CAPSULAR CONTRACTURE BAKER GRADE 3, VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. COMPLICATIONS ON THE LEFT BREAST/IMPLANT HAVE BEEN REPORTED UNDER MRN: 1645337-2022-06911 THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Crushing Injury

  MAUDE report 15126110 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, MAMMOGRAM AND MRI, WITH LEFT BREAST IMPLANT RUPTURE. THE PATIENT ALSO POSSIBLY SUFFERED TRAUMA FROM MAMMOGRAM. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Crushing Injury

  MAUDE report 14682162 ↗
• InjuryJan 6, 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 UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 535CC AND EXPERIENCED SUSPECTED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2021. DURING EXPLANTATION, THE DEVICE WAS FOUND TO BE INTACT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13178835 ↗
• InjuryAug 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 535CC AND EXPERIENCED GRANULOMA AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE GRANULOMA WAS DISCOVERED DURING A BIOPSY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Granuloma

  MAUDE report 12344997 ↗
• InjuryMay 13, 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 CAUCASIAN FEMALE WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT, 535CC SILICONE PROSTHESIS, EXPERIENCED BILATERAL GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE ISSUE WAS CONFIRMED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11816794 ↗
• InjuryMay 13, 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 CAUCASIAN FEMALE WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT, 535CC SILICONE PROSTHESIS, EXPERIENCED BILATERAL GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE ISSUE WAS CONFIRMED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11816596 ↗
• InjuryJul 22, 2020Adverse 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 PRIMARY BREAST AUGMENTATION WITH 535CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10309573 ↗
• InjuryOct 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 535CC AND EXPERIENCED A BREAST MASS AND A SILENT RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: Breast Mass; No Code Available

  MAUDE report 9211140 ↗
• InjuryOct 14, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). MENTOR¿S PSR EXEMPTION #E2007003. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL 535CC SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED AFTER IMPLANTATION. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: RIGHT REPLACED WITH CATALOG NUMBER SMPX-295, SERIAL NUMBER (B)(4), AND LEFT REPLACED WITH CATALOG NUMBER SMPX-295, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9186014 ↗