MENTOR MemoryGel Breast Implant 3501754BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00081317000419), received between Oct 21, 2019 and May 18, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV ALONG WITH RUPTURE 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 25202087 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 175CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 21579670 ↗
• InjuryMar 7, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21552168 ↗
• InjuryMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 175 CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 175 CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21508851 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 175CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III FOLLOWING IMPLANTATION.. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21223817 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20162783 ↗
• InjuryJun 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19578956 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST PAIN, RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III), LEFT BREAST BOTTOMING OUT AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19255082 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE AND BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE RUPTURE WAS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2024-00941. ON APRIL 2, 2024 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19175607 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 18576671 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 200CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 175CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED A RIGHT SIDED BREAST LUMP WITH PAIN AND LEFT SIDED MISSHAPENNESS OF THE BREAST POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-14886 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18360935 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III TO IV). THE RIGHT BREAST HAS SUPERIOR DISPLACEMENT, FLATTENING OF THE LOWER POLE AND LOWER NAC POSITION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18000165 ↗
• InjuryOct 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESIS EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17901309 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. PATIENT REPORTED A SMALL LUMP ON LEFT BREAST. THE MENTIONED LUMP IS ASSESSED AS A SYMPTOM OF THE REPORTED DEVICE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER 3502004BC; SERIAL NUMBER (B)(6) ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17299523 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH CAPSULAR CONTRACTURE OF THE RIGHT BREAST BY A MEDICAL PROFESSIONAL. HOWEVER, A BAKER GRADE RATING WAS NOT PROVIDED. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 170CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 17011574 ↗
• InjuryMar 21, 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 UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, 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 16585185 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 175CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II/III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15887568 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 175CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II/III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15887564 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH A 225CC MENTOR SMOOTH ROUND SPECTRUM (CATALOG: 3501430, LOT: 567254, SN: (B)(4)) ON (B)(6) 2007.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15801465 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 15794097 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 190CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE ON (B)(6) 2019, AND WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE ON (B)(6) 2019 AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND BILATERAL BREAST MASS POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2022. THE MASSES WERE FOUND TO BE BENIGN UPON REMOVAL. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Breast Mass

  MAUDE report 15076198 ↗
• InjuryJul 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI AND VIA 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 15009174 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 13906829 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 13906817 ↗
• InjuryJan 12, 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 BREAST RECONSTRUCTION SURGERY WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON ONE SIDE, AND WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE OTHER SIDE AT AN UNKNOWN DATE, AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, ASYMMETRY, AND DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3502754BC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501754BC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 13236304 ↗