MENTOR MemoryGel BOOST Breast Implant SMPB320Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00081317026860), received between Sep 12, 2022 and Sep 28, 2026 — classified as 29 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 320cc MENTOR MemoryGel BOOST Breast Implant prosthesis. Post-operatively, the patient experienced pain and hardness of the right breast. She was diagnosed with right breast Baker Grade III Capsular Contracture and a ruptured right implant. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50916005 ↗
• MalfunctionSep 2, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569615 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT WAS SCHEDULED FOR RIGHT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. FOR THE LEFT SIDE, 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: Capsular Contracture

  MAUDE report 25415232 ↗
• MalfunctionDec 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BOOST BREAST IMPLANTS BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE RUPTURE 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 23889438 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 20-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 320CC (LEFT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 390CC (RIGHT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23830103 ↗
• InjuryNov 13, 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 WITH A 340CC (LEFT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 320CC (RIGHT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 310CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT SIDE AND A 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE RIGHT SIDE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23543797 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST, 320CC SILICONE PROSTHESIS EXPERIENCE BILATERAL CAPSULAR CONTRACTURES GRADE III POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 23393847 ↗
• MalfunctionAug 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO BE RUPTURED PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795133 ↗
• InjuryMay 29, 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 BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 320CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22108725 ↗
• InjuryApr 30, 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 PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BOOST 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. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21938165 ↗
• InjuryApr 30, 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE WAS ACCOMPANIED BY STIFFNESS AND THE IMPLANT SITTING HIGHER. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21937661 ↗
• InjuryApr 23, 2025Adverse 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL LEFT-SIDED REMOVAL AND REPLACEMENT WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21895931 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 21586742 ↗
• InjuryMar 11, 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS NOT COMPLIANT WITH POST-OPERATION BREAST COMPRESSION BY LIFTING HEAVY BOXES. THE PATIENT DEVELOPED RAPID SEROMA ON THE LEFT ARM, BREAST PAIN, AND DIFFICULTIES WITH COMPRESSION. THE PATIENT ALSO EXPERIENCED ALLERGIC REACTION TO SILICONE SCAR TAPE ON BOTH THE BREASTS' INCISIONS. ONCE THE INFECTION CLEARED, THE PATIENT THEN DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III - IV) AND RIGHT BREAST PTOSIS. THE LEFT BREAST WAS ELEVATED, COOL TO TOUCH, AND PAINFUL. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST REVISION AND LEFT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE LEFT BREAST IMPLANT WAS REPLACED WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SMPB320 LOT: 2003974 SN: (B)(6)). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Local Reaction

  MAUDE report 21577203 ↗
• InjuryMar 11, 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS NOT COMPLIANT WITH POST-OPERATION BREAST COMPRESSION BY LIFTING HEAVY BOXES. THE PATIENT DEVELOPED RAPID SEROMA ON THE LEFT ARM, BREAST PAIN, AND DIFFICULTIES WITH COMPRESSION. THE PATIENT ALSO EXPERIENCED ALLERGIC REACTION TO SILICONE SCAR TAPE ON BOTH THE BREASTS' INCISIONS. ONCE THE INFECTION CLEARED, THE PATIENT THEN DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III - IV) AND RIGHT BREAST PTOSIS. THE LEFT BREAST WAS ELEVATED, COOL TO TOUCH, AND PAINFUL. AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST REVISION AND LEFT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE LEFT BREAST IMPLANT WAS REPLACED WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SMPB320 LOT: 2003974 SN: (B)(6)). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Post Operative Wound Infection; Seroma

  MAUDE report 21577198 ↗
• InjuryFeb 20, 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21428275 ↗
• InjuryFeb 7, 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 SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21335257 ↗
• InjuryJan 27, 2025Migration; Migration

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE AND DEVICE MIGRATION (LATERAL SHIFT) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21248973 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE AND DEVICE MIGRATION (LATERAL SHIFT) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21248972 ↗
• InjuryJan 6, 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 PRIMARY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 320CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT 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 21085720 ↗
• InjuryNov 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PROCEDURE WAS BEING PERFORMED WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND SOME UNUSUAL LOOKING BUBBLES WERE NOTED ON THE DEVICE. THIS DEVICE WAS REMOVED AND A NEW 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS PLACED. WHILE CLOSING THE IMPLANT SITE THE NEW 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS RUPTURED. THE RUPTURED DEVICE COULD NOT BE USED. THE CONTRALATERAL DEVICE HAD TO BE EXPLANTED SO THE PATIENT COULD HAVE A DEVICE OF THE SAME SIZE ON EACH SIDE. THIS RESULT WAS ASSESSED AS AN ADDITIONAL SURGICAL INTERVENTION WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20731031 ↗
• InjuryNov 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PROCEDURE WAS BEING PERFORMED WITH A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND SOME UNUSUAL LOOKING BUBBLES WERE NOTED ON THE DEVICE. THIS DEVICE WAS REMOVED AND A NEW 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS PLACED. WHILE CLOSING THE IMPLANT SITE THE NEW 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS RUPTURED. THE RUPTURED DEVICE COULD NOT BE USED. THE CONTRALATERAL DEVICE HAD TO BE EXPLANTED SO THE PATIENT COULD HAVE A DEVICE OF THE SAME SIZE ON EACH SIDE. THIS RESULT WAS ASSESSED AS AN ADDITIONAL SURGICAL INTERVENTION WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20731028 ↗
• InjuryNov 5, 2024Adverse 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 320CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 320CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20612677 ↗
• InjuryJun 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 A 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3-4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19524187 ↗
• InjuryMar 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 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 18852959 ↗