MENTOR MemoryGel BOOST Breast Implant SHPB775Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00081317027157), received between Sep 22, 2022 and Sep 17, 2026 — classified as 31 injuries, 2 malfunctions.

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

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 775cc MENTOR MemoryGel BOOST Breast Implants. Post-operatively, the patient was diagnosed, via physical examination, with right breast capsular contracture (baker grade IV). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50806258 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 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 25058082 ↗
• InjuryOct 15, 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 775CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23294827 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS PLACED EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, BILATERAL REPLACEMENT WAS PERFORMED ON (B)(6) 2024. THE CAPSULAR CONTRACTURE WAS REPORTED INITIALLY UNDER 1645337-2024-14658. ON AUGUST 12, 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22828384 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BOOST, 775CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE III, AND BILATERAL NIPPLE NECROSIS POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR EFT SIDE CAPSULECTOMY AND BILATERAL REPLACEMENTS AS FOLLOW: CAT: 3502800, SN: (B)(6), SN: (B)(6) ON (B)(6) 2025. THE SIDES WERE NOT REPORTED. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Necrosis

  MAUDE report 21877864 ↗
• InjuryMar 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 775CC 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

  MAUDE report 21699151 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BOOST, 775CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE IV POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Necrosis

  MAUDE report 21668871 ↗
• InjuryFeb 20, 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 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM 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 21425740 ↗
• InjuryFeb 12, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, BOOST 775CC SILICONE PROSTHESIS AND SUBSEQUENTLY EXPERIENCED RIGHT-SIDED RUPTURES, AND RIPPLING FOLLOWING IMPLANTATION, ALONG WITH SIGNIFICANT PAIN TO THE CHEST WALL. UPON REPOSITIONING THE IMPLANT, IT WAS DISCOVERED THAT THE IMPLANT WAS SEVERELY RUPTURED. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH A RIGHT CATALOG SHPB775 PROSTHESIS, SERIAL NUMBER (B)(6) ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 21368316 ↗
• InjuryJan 28, 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 RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21260955 ↗
• InjuryJan 28, 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 RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21260954 ↗
• InjuryJan 28, 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 A MENTOR MEMORYGEL BOOST PROSTHESIS (775CC) EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, CLASSIFIED AS GRADE IV ON THE LEFT SIDE AND GRADE II ON THE RIGHT, FOLLOWING IMPLANTATION. THE PATIENT'S SYMPTOMS CONFIRMED THE DIAGNOSIS, AND SHE HAS BEEN PLACED ON SINGULAIR AND QUERCETIN DAILY AS PART OF HER TREATMENT REGIMEN. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR AN ANTICIPATED EXPLANTATION DATE, WITH THIS REPORT SPECIFICALLY RELATING TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21256960 ↗
• InjuryJan 28, 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 A MENTOR MEMORYGEL BOOST PROSTHESIS (775CC) EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, CLASSIFIED AS GRADE IV ON THE LEFT SIDE AND GRADE II ON THE RIGHT, FOLLOWING IMPLANTATION. THE PATIENT'S SYMPTOMS CONFIRMED THE DIAGNOSIS, AND SHE HAS BEEN PLACED ON SINGULAIR AND QUERCETIN DAILY AS PART OF HER TREATMENT REGIMEN. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR AN ANTICIPATED EXPLANTATION DATE, WITH THIS REPORT SPECIFICALLY RELATING TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21256922 ↗
• InjuryDec 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PLACED EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE ON AN UNKNOWN SIDE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON(B)(6) 2024. TWO SERIAL AND LOT NUMBERS WERE PROVIDED, HOWEVER, THE IMPACTED DEVICE WAS NOT CLARIFIED. THIS IS REFLECTED IN SECTION D.

  Patient problems: Capsular Contracture

  MAUDE report 20953809 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20837421 ↗
• InjuryOct 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20467839 ↗
• InjurySep 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 775CC. THE PATIENT WANTED TO BE A LARGER SIZE, AND AS A RESULT, UNDERWENT REMOVAL ON (B)(6) 2024. UPON EXPLANATION, THE RIGHT BREAST PROSTHESIS WAS FOUND TO BE DEFORMED.

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

  MAUDE report 20259138 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, BOOST, 775CC SILICONE EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III ON THE LEFT, II ON THE RIGHT SIDE , AND SEVER ASYMMETRY ISSUE POSTOPERATIVE. THE PHYSICAL EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY AND BILATERAL REPLACEMENTS WITH R/ SN: (B)(6), L/ 9664051-062 ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20136548 ↗
• 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA AN IN-OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 750CC SALINE BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20035264 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, BOOST, 775CC SILICONE EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19492952 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 19232056 ↗
• InjuryMar 21, 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 775CC MENTOR MEMORYGEL BOOST 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 18954112 ↗
• InjuryFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 775CC GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. THE PATIENT NOTICED THE POSSIBLE RUPTURE OF HER LEFT BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18760328 ↗
• MalfunctionJan 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS FOUND TO HAVE RIPPLES AND LOSS OF FORM STABILITY 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 18486387 ↗
• InjuryOct 31, 2023Adverse 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 A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18043329 ↗