MENTOR MemoryGel Breast Implant 3507800BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317000198), received between Feb 28, 2019 and Feb 6, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Material Rupture” (27 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE 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: Deformity/ Disfigurement

  MAUDE report 24279878 ↗
• InjuryNov 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH 550CC MENTOR SILTEX CONTOUR PROFILE HIGH AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE VIA MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20747986 ↗
• InjurySep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 450CC (LEFT) AND 800CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A SKIN REACTION ON THE LEFT AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED ¿INTERNAL EXTREME ITCHING¿ ON THE LEFT AND THAT THE RIGHT SEEMED SMALLER. 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: Deformity/ Disfigurement

  MAUDE report 20153476 ↗
• InjuryDec 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY A LEFT SIDED WATERFALL DEFORMITY AND THE LEFT SIDED IMPLANT SITTING HIGH AND NEAR THE ARMPIT. THE RUPTURES WERE CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, REPLACEMENT WITH SALINE IMPLANTS WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-14935 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18366789 ↗
• InjuryDec 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY A LEFT SIDED WATERFALL DEFORMITY AND THE LEFT SIDED IMPLANT SITTING HIGH AND NEAR THE ARMPIT. THE RUPTURES WERE CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, REPLACEMENT WITH SALINE IMPLANTS WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-14937 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18366787 ↗
• InjuryJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3508001BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND WITH CATALOG NUMBER 3508001BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17182896 ↗
• InjuryMar 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. A MASS WAS NOTICED ON THE PATIENT¿S RIGHT BREAST. THE RUPTURE WAS DIAGNOSED VIA AN IN-OFFICE EXAM AND VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16567063 ↗
• InjuryOct 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12770 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15661637 ↗
• InjuryOct 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15661564 ↗
• InjuryJun 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL, 800CC BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POSTOPERATIVE. THE MRI AND MAMMOGRAM EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH MENTOR SILICONE ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 14645098 ↗
• InjuryJun 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL, 800CC BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POSTOPERATIVE. THE MRI AND MAMMOGRAM EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH MENTOR SILICONE ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 14645052 ↗
• InjuryMay 12, 2022Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE, BILATERAL PTOSIS, AND BILATERAL SUPERIOR MIGRATION POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS, MASTOPEXY, AND INFERIOR CAPSULOTOMY WAS PERFORMED ON (B)(6) 2022. THE LEFT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2022-04490 ON (B)(6) 2022. ON (B)(6) 2022 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14383262 ↗
• InjuryApr 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14164493 ↗
• InjuryNov 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT RUPTURE, POST-PROCEDURE. THE RUPTURE WAS ONLY DISCOVERED DURING A REVISION SURGERY FOR UNSPECIFIED REASONS ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REMOVED AND REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 790CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX790 LOT: 9589676 SN: (B)(4) AND (RIGHT) 790CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX790 LOT: 9589678 SN: (B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12800770 ↗
• InjuryOct 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12668703 ↗
• InjuryAug 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. 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: Deformity/ Disfigurement

  MAUDE report 12381145 ↗
• InjuryAug 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. 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 12381140 ↗
• InjuryJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC (L) AND A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC BREAST IMPLANT (R) AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR BREAST IMPLANTS ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12094868 ↗
• InjuryMay 11, 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 PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC AND SUFFERED FROM CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE SYMPTOMATIC ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAS UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICE ON (B)(6) 2020. ON (B)(6) 2021, IT WAS REPORTED TO MENTOR THAT THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE BREAST. POSSIBLE LEFT SIDE RUPTURE SECONDARY TO TRAUMA ¿ CHEST INJURY- ((B)(6) 2020 ¿ SEVERE MOTORCYCLE ACCIDENT) , NOW WITH MALPOSITION AND CAPSULAR CONTRACTURE. THE REPLACEMENT DEVICES WERE ALLERGAN BRAND SCX GEL IMPLANTS. THE PATIENT HAD UNDERGONE REMOVAL OF LEFT RUPTURED SILICONE IMPLANT WITH SOME EXTRACAPSULAR SILICONE EXTRUSION, RECONSTRUCTION AND REPAIR OF LEFT PECTORALIS MAJOR MUSCLE ON (B)(6) 2020. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 11809343 ↗
• InjuryFeb 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC AND SUFFERED FROM A RUPTURE ON THE RIGHT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2010.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11325933 ↗
• InjuryJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE OF IMPLANTS POSTOPERATIVELY. RUPTURE WAS DIAGNOSED BY MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11198393 ↗
• InjuryJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE OF IMPLANTS POSTOPERATIVELY. RUPTURE WAS DIAGNOSED BY MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11198392 ↗
• InjuryDec 7, 2020Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC AND SUFFERED FROM CAPSULAR CONTRACTURE AND RUPTURE SYMPTOMATIC ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAS UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICE ON (B)(6) 2020.

  Patient problems: Capsular Contracture; Fall

  MAUDE report 10960783 ↗
• InjuryMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE PATIENT UNDERWENT IMPLANT REPLACEMENT ON (B)(6) 2020. THE IMPLANT WAS CONFIRMED TO BE RUPTURE UPON EXPLANT.

  Patient problems: No Code Available

  MAUDE report 9788754 ↗
• InjuryMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH COMPETITOR PRODUCTS ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9788413 ↗