MENTOR MemoryGel Breast Implant 3543857MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317004431), received between Aug 30, 2019 and May 5, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 385CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE RIGHT BREAST WAS ALSO FOUND TO HAVE RUPTURED. IN ADDITION, THE PATIENT ALSO MENTIONED THAT THEY WERE ALSO DIAGNOSED WITH STAGE III OVARIAN CANCER. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Cancer; Deformity/ Disfigurement

  MAUDE report 21962259 ↗
• InjuryMay 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 385CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE RIGHT BREAST WAS ALSO FOUND TO HAVE RUPTURED. IN ADDITION, THE PATIENT ALSO MENTIONED THAT THEY WERE ALSO DIAGNOSED WITH STAGE III OVARIAN CANCER. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cancer; Deformity/ Disfigurement

  MAUDE report 21962255 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 385CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT DESIRED A BILATERAL MASTOPEXY AND LARGER BREAST IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 535CC (LEFT-SIDED) AND 595CC (RIGHT-SIDED) MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2024. DURING THE SURGERY, A RUPTURED LEFT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02038 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18747694 ↗
• InjuryJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 385CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS DIAGNOSED USING THE PATIENT¿S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-00682 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18530449 ↗
• InjuryJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 385CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS DIAGNOSED USING THE PATIENT¿S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-00681 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18529118 ↗
• InjuryOct 27, 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 PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT PROTHESES (LEFT: 360CC, RIGHT: 385CC) AND EXPERIENCED POSTOPERATIVE BILATERAL BREAST PAIN, AND LEFT-SIDED RUPTURE AND LATE ONSET SEROMA. MRI AND MAMMOGRAM PERFORMED ON (B)(6) 2021 INDICATED THE LEFT-SIDED RUPTURE. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Pain

  MAUDE report 12706937 ↗
• InjuryJul 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 385CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12189403 ↗
• InjuryFeb 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH 385CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POSTOPERATIVELY. THE RUPTURE WAS CONFIRMED WITH A MAMMOGRAM AND X-RAY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11304967 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 385CC SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED, AND THERE WAS BILATERAL IMPLANT DEFORMITY AND SYMMASTIA AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEFORMITY AND SYMMASTIA CORRECTED WITH INFRAMAMMARY FOLD REPAIR, AND PLACEMENT OF BILATERAL BELLA DERM GRAFTS; REVISION MASTOPEXY, AND BILATERAL REMOVAL OF IMPLANTS ON (B)(6) 2020. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. SILICONE RIGHT IMPLANT RUPTURE NOTICED DURING REMOVAL SURGERY. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 9992098 ↗
• InjuryMar 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 385CC SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. SILICONE RUPTURE NOTICED DURING REMOVAL SURGERY. PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9899656 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 385CC MENTOR MEMORYGEL, BREAST IMPLANTS ON (B)(6) 2011 EXPERIENCED PAIN AND SWELLING IN THE MEDIAL RIGHT BREAST, AND LEFT BREAST CHANGE IN SHAPE. THE PATIENT UNDERWENT ULTRASOUND ON (B)(6) 2018 ON HER RIGHT BREAST THAT SHOWED SUSPECTED INTRACAPSULAR RUPTURE OF THE RIGHT BREAST IMPLANT AT ITS MEDIAL ASPECT AND MULTIPLE SMALL CYSTS. THE PATIENT WAS NOTED TO HAVE BAKER GRADE III CAPSULAR CONTRACTURE ON (B)(6) 2018. THE PATIENT UNDERWENT EXPLANTATION, AND REPLACEMENT WITH CATALOG NUMBER 3504501BC; SERIAL NUMBER: (B)(4) ON THE RIGHT SIDE AND WITH CATALOG NUMBER 3504501BC; SERIAL NUMBER: (B)(4) ON THE LEFT SIDE ON (B)(6) 2019. IT IS UNCLEAR WHETHER OR NOT THE DEVICES WERE RUPTURED UPON EXPLANTATION. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 8950093 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 385CC MENTOR MEMORYGEL, BREAST IMPLANTS ON (B)(6) 2011 EXPERIENCED PAIN AND SWELLING IN THE MEDIAL RIGHT BREAST, AND LEFT BREAST CHANGE IN SHAPE. THE PATIENT UNDERWENT ULTRASOUND ON (B)(6) 2018 ON HER RIGHT BREAST THAT SHOWED SUSPECTED INTRACAPSULAR RUPTURE OF THE RIGHT BREAST IMPLANT AT ITS MEDIAL ASPECT AND MULTIPLE SMALL CYSTS. THE PATIENT WAS NOTED TO HAVE BAKER GRADE III CAPSULAR CONTRACTURE ON (B)(6) 2018. THE PATIENT UNDERWENT EXPLANTATION, AND REPLACEMENT WITH CATALOG NUMBER 3504501BC; SERIAL NUMBER: (B)(4) ON THE RIGHT SIDE AND WITH CATALOG NUMBER: 3504501BC; SERIAL NUMBER: (B)(4) ON THE LEFT SIDE ON (B)(6) 2019. IT IS UNCLEAR WHETHER OR NOT THE DEVICES WERE RUPTURED UPON EXPLANTATION. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Cyst(s); No Code Available

  MAUDE report 8950090 ↗