MENTOR MemoryGel Breast Implant 3507425MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00081317004202), received between May 13, 2019 and Apr 23, 2026 — classified as 83 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (46 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 84 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24965210 ↗
• InjuryDec 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CYST THAT CAUSED DISCOMFORT, RADIATING PAIN, AND DEFORMITY. THE PATIENT WAS EVENTUALLY DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, THE PATIENT WAS ALSO DEVELOPED ASYMMETRY AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST CYST EXCISION AND BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Cyst(s)

  MAUDE report 23894382 ↗
• InjuryDec 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CYST THAT CAUSED DISCOMFORT, RADIATING PAIN, AND DEFORMITY. THE PATIENT WAS EVENTUALLY DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, THE PATIENT WAS ALSO DEVELOPED ASYMMETRY AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST CYST EXCISION AND BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23894381 ↗
• InjuryNov 20, 2025Adverse 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 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23609300 ↗
• InjuryNov 20, 2025Adverse 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 425CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23609290 ↗
• InjurySep 12, 2025Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 470CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE AND BREAST PROSTHESIS RUPTURE POST IMPLANTATION. LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE AND LEFT BREAST PROSTHESIS RUPTURE WERE INITIALLY REPORTED. CT SCAN RESULTS WERE LATER PROVIDED, AND THEY DIAGNOSED BILATERAL BREAST PROSTHESIS RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. DURING EXPLANT SURGERY, THE SURGEON DIAGNOSED THE PATIENT WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23042564 ↗
• InjuryJul 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT 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 DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22457377 ↗
• InjuryMay 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 425CC (LEFT) AND A 235CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANTAND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BILATERAL BREAST PTOSIS, AND BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT FELT HARDNESS ON THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH TWO MENTOR BREAST PROSTHESES (SERIAL NUMBER (B)(6) ON THE LEFT AND SERIAL NUMBER (B)(6) ON THE RIGHT). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21946642 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. THE PATIENT HAD REPORTED HARDENING AND DISPLACEMENT WITH THE CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 21873724 ↗
• MalfunctionMar 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ONE PRODUCT WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON MONTH XX, 2024 WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: Insufficient Information

  MAUDE report 21636999 ↗
• InjuryFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21374764 ↗
• InjuryFeb 7, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL, UTILIZING A 425CC SILICONE PROSTHESIS, EXPERIENCED A LEFT-SIDED SILENT RUPTURE POST-OPERATIVELY. AS A RESULT OF THIS COMPLICATION, THE PATIENT UNDERWENT A UNILATERAL REPLACEMENT ON (B)(6) 2024, WITH THE LEFT IMPLANT IDENTIFIED BY CATALOG NUMBER 3503751BC AND SERIAL NUMBER (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21337636 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21315635 ↗
• InjuryJan 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 340CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DISCOVERED DURING EXPLANT. IMPLANT EXCHANGE WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21160065 ↗
• InjuryDec 27, 2024Adverse 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 WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024 .

  Patient problems: Capsular Contracture

  MAUDE report 21030908 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20844797 ↗
• InjuryOct 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20582738 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 20271668 ↗
• InjuryAug 23, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE AND BILATERAL INFECTION POST-OPERATIVELY. THE PATIENT HAD RECENT EPISODES OF INFECTION WITH PAIN AND SWELLING (WORSE ON THE LEFT) FOR WHICH THE PATIENT HAD SEVERAL ROUNDS OF ANTIBIOTICS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AUGUST 13, 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Post Operative Wound Infection

  MAUDE report 20047293 ↗
• InjuryAug 23, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 425CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE AND BILATERAL INFECTION POST-OPERATIVELY. THE PATIENT HAD RECENT EPISODES OF INFECTION WITH PAIN AND SWELLING (WORSE ON THE LEFT) FOR WHICH THE PATIENT HAD SEVERAL ROUNDS OF ANTIBIOTICS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Post Operative Wound Infection

  MAUDE report 20045010 ↗
• InjuryAug 5, 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 SURGERY WITH IMPLANTATION OF A 425CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A HEMATOMA OF THE LEFT BREAST BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 19912063 ↗
• InjuryJun 10, 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 425CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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 19499295 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 425CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19313077 ↗
• InjuryMar 11, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18881356 ↗
• InjuryMar 11, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18881346 ↗