MENTOR MemoryGel BOOST Breast Implant SMHB500Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10081317031144), received between Feb 27, 2024 and Sep 9, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a 500cc MENTOR MemoryGel BOOST Breast Implant experienced capsular contracture Bake Grade 3 on the right side post-operatively. At the time of this report, Mentor has received no information regarding explanation or an expected explanation date.

  Patient problems: Capsular Contracture

  MAUDE report 50696049 ↗
• InjuryMar 6, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24533733 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24533724 ↗
• InjuryFeb 10, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BREAST ASYMMETRY, DISCOMFORT, AND NUMBNESS IN THE EXTREMITIES. DURING PHYSICAL EXAMINATIONS, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV (LEFT BREAST) AND I-II (RIGHT BREAST) CAPSULAR CONTRACTURE AND BILATERAL IMPLANT MALPOSITION. ULTRASOUND IMAGING INDICATED SOME FLUID AROUND THE IMPLANT AREA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions; Paresthesia

  MAUDE report 24308531 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED SKIN ISSUES ON THE BREASTS POST IMPLANTATION. INGREDIENTS LIST FOR THE BREAST PROSTHESES WAS REQUESTED. ADDITIONALLY, PATIENT¿S DERMATOLOGIST WANTS TO DO PATCH TESTING. THE PATIENT HAS BLISTERS ON HER BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23949405 ↗
• InjurySep 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 500CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 635CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23034252 ↗
• InjurySep 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 500CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 635CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23034251 ↗
• MalfunctionAug 27, 2025Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO BE RUPTURED DURING AN 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 22904253 ↗
• InjuryAug 25, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 500CC SMOOTH MOD HIGH BOOST AND EXPERIENCED WOUND INFECTION AND DISCOLORATION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22891328 ↗
• MalfunctionJul 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO HAVE FOREIGN MATTER (HAIR) ON IT PRIOR TO SURGERY. 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 22480757 ↗
• InjuryMar 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 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED AUTOIMMUNE LIKE SYMPTOMS AND GENERALIZED ILLNESS. THEY HAD FEVER, CHILLS, RIGHT BREAST REDNESS, DISCOMFORT, SWELLING, MALAISE, AND POSSIBLY RIGHT BREAST CELLULITIS. THE PATIENT WAS PUT ON ANTIBIOTICS. THERE WAS ALSO LOSS OF VOLUME NOTED ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND A RUPTURED RIGHT BREAST IMPLANT. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 21658486 ↗
• InjuryMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED AUTOIMMUNE LIKE SYMPTOMS AND GENERALIZED ILLNESS. THEY HAD FEVER, CHILLS, RIGHT BREAST REDNESS, DISCOMFORT, SWELLING, MALAISE, AND POSSIBLY RIGHT BREAST CELLULITIS. THE PATIENT WAS PUT ON ANTIBIOTICS. THERE WAS ALSO LOSS OF VOLUME NOTED ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND A RUPTURED RIGHT BREAST IMPLANT. THE IMPLANTS WERE NOT REPLACED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 21658483 ↗
• InjuryJan 21, 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 500CC 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 21198280 ↗
• MalfunctionJan 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT HAD SHELL IRREGULARITIES DURING THE PROCEDURE. THE DEVICE APPEARED CREASED WHILE BEING USED ON THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108017 ↗
• InjuryOct 1, 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 MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20348832 ↗
• InjuryFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement; Pocket Erosion; Post Operative Wound Infection

  MAUDE report 18794166 ↗