MENTOR MemoryGel BOOST Breast Implant SHPB685Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317027133), received between Apr 6, 2023 and May 1, 2026 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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.

• MalfunctionMay 1, 2026Material Deformation

  IT WAS REPORTED THAT AN UNSPECIFIED GEL BREAST PROSTHESIS BEING USED IN A BREAST SURGERY WAS FOUND TO BE DEFECTIVE (SHELL IRREGULARITIES) DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057891 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24944866 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED BEING DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24437770 ↗
• InjuryDec 26, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23897163 ↗
• InjuryDec 3, 2025Adverse 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23706925 ↗
• InjuryAug 11, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON JULY 16, 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22776138 ↗
• InjuryAug 7, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). THE BREAST WAS HARD. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22743443 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 685CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. IT WAS REPORTED THAT THE BREAST WAS BLACK AND SWOLLEN AND THE PATIENT DEVELOPED FEVER AND CHILLS. THE BREAST WAS EXAMINED AND A HEALTHCARE PROFESSIONAL NOTED THAT THERE WAS DEHISCENCE OF THE LEFT BREAST SURGICAL WOUND WITH AN EXPOSED IMPLANT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 685CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Pocket Erosion; Post Operative Wound Infection

  MAUDE report 22391481 ↗
• InjuryJul 2, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED A WOUND INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22385726 ↗
• InjuryJun 27, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 22347060 ↗
• InjuryMay 28, 2025Adverse 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 WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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

  MAUDE report 22095900 ↗
• InjuryApr 28, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 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: Capsular Contracture

  MAUDE report 21919939 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 685CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21893399 ↗
• MalfunctionMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS POTENTIALLY RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576706 ↗
• InjuryFeb 19, 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 IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 685CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21414406 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 685CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21414403 ↗
• InjuryJan 6, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST REVISION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL AS SHE HAD A STIFF AND ELEVATED LEFT BREAST THAT APPEARED SMALLER THAN THE RIGHT BREAST. DURING A SECONDARY FOLLOW-UP, SHE WAS NOTED TO HAVE RIGHT BREAST IMPLANT BOTTOMING OUT AND SHE WAS DIAGNOSED WITH RIGHT BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 740CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21087331 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH THE PROCEDURE OUTCOME POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20920373 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20508321 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THIS RESULTED IN BREAST ASYMMETRY. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED), MORE SIGNIFICANT ON THE RIGHT BREAST. THIS CAUSED THE RIGHT BREAST NIPPLE AREOLAR DISPLACEMENT AND IMPLANT MALPOSITION. THERE WERE ALSO RIPPLING AND SCALLOPING IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT FAT GRAFTING, CAPSULOTOMY, CAPSULORRHAPHY, AND BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB635 LOT: 9990208 SN: (B)(6) AND (LEFT) 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB635 LOT: 9990208 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20424772 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THIS RESULTED IN BREAST ASYMMETRY. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED), MORE SIGNIFICANT ON THE RIGHT BREAST. THIS CAUSED THE RIGHT BREAST NIPPLE AREOLAR DISPLACEMENT AND IMPLANT MALPOSITION. THERE WERE ALSO RIPPLING AND SCALLOPING IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT FAT GRAFTING, CAPSULOTOMY, CAPSULORRHAPHY, AND BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (RIGHT) 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB635 LOT: 9990208 SN: (B)(6) AND (LEFT) 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB635 LOT: 9990208 SN: (B)(6) . THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20424154 ↗
• InjurySep 14, 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 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20219112 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) .2024.

  Patient problems: Capsular Contracture

  MAUDE report 20127552 ↗
• InjuryAug 23, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED LEFT SIDED DEVICE MIGRATION AND RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED DEVICE WOULD NOT STAY IN THE POCKET. THE RIGHT SIDED DEVICE CAVES IN BY THE NIPPLE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20046449 ↗
• InjuryAug 22, 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 REVISION WITH 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED LEFT SIDED DEVICE MIGRATION AND RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED DEVICE WOULD NOT STAY IN THE POCKET. THE RIGHT SIDED DEVICE CAVES IN BY THE NIPPLE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20043469 ↗