MENTOR MemoryGel BOOST Breast Implant SMHB400Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10081317031281), received between Jun 5, 2024 and Jul 27, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent a breast augmentation revision with a 400cc (Left) MENTOR MemoryGel BOOST Breast Implant and 375cc (Right) MENTOR MemoryGel BOOST Breast Implant and and experienced bilateral capsular contracture (baker grade 4) post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prostheses. This report is for the left side device.

  Patient problems: Capsular Contracture

  MAUDE report 50009080 ↗
• InjuryJun 4, 2026Adverse 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 GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. THE PATIENT NOTICED THAT THE LEFT BREAST IS GETTING HIGHER AND FIRMER. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 25394802 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Capsular Contracture

  MAUDE report 25021250 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 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 24757892 ↗
• InjuryMar 26, 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 RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Capsular Contracture

  MAUDE report 24701672 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 400CC 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. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 24456750 ↗
• MalfunctionFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO BE RUPTURED PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316303 ↗
• InjuryJan 16, 2026Migration

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BOOST, 400CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE GRADE IV, DEVICE MIGRATION POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24094675 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 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 23537451 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BOOST, 400CCC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED CAPSULAR CONTRACTURE GRADE IV POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22545681 ↗
• InjuryJun 13, 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, 400CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22203697 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 400 CC AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22146396 ↗
• InjuryMay 12, 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 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY THE DEVICE RIDING HIGH. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22003013 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY INVOLVING MENTOR MEMORYGEL BOOST 400CC ON THE RIGHT, AND 260CC ON THE LEFT SIDE, SILICONE PROSTHESIS EXPERIENCED BILATERAL WOUND INFECTION POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21945258 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY INVOLVING MENTOR MEMORYGEL BOOST 400CC ON THE RIGHT, AND 260CC ON THE LEFT SIDE, SILICONE PROSTHESIS EXPERIENCED BILATERAL WOUND INFECTION POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21945180 ↗
• InjuryApr 23, 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 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE, A BREAST MASS, AND A LOCAL REACTION 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: Breast Mass; Capsular Contracture; Local Reaction

  MAUDE report 21892027 ↗
• InjuryMar 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 400 CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE IMPLANT WAS REMOVED AND REINSERTED. THIS IS CONSIDERED USE-ERROR OF THE PRODUCT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21620796 ↗
• InjuryMar 12, 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 400CC 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 IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21586819 ↗
• InjuryMar 3, 2025Material 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 IMPLANTED WITH A 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21508812 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT INDICATED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 400 CC SILICONE PROSTHESIS SUBSEQUENTLY EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV, AND BILATERAL BREAST REDNESS POSTOPERATIVELY, AS DIAGNOSED THROUGH THE PATIENT¿S REPORTED SYMPTOMS. IN RESPONSE TO THIS COMPLICATION, THE PATIENT HAS UNDERWENT A UNILATERAL OF THE LEFT SIDE REPLACEMENT WITH CAT: SMHB-400, SN: (B)(6), AND CAPSULECTOMY ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21294155 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT INDICATED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 400 CC SILICONE PROSTHESIS SUBSEQUENTLY EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVELY, AS DIAGNOSED THROUGH THE PATIENT¿S REPORTED SYMPTOMS. IN RESPONSE TO THIS COMPLICATION, THE PATIENT HAS SCHEDULED A UNILATERAL REPLACEMENT PROCEDURE FOR (B)(6) 2025.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 21083405 ↗
• InjuryDec 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 400CC AND EXPERIENCED HEMATOMA AND CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE LEFT SIDE ALONG WITH POSSIBLE RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20834401 ↗
• InjuryDec 3, 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 REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 400CC AND EXPERIENCED HEMATOMA AND CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE LEFT SIDE ALONG WITH POSSIBLE RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 20834399 ↗
• InjuryNov 18, 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 400CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20713598 ↗
• InjuryOct 16, 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 SURGERY WITH TWO 400CC 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 (B)(6) 2024. THE REPLACEMENT DEVICES ARE 370CC MENTOR SMOOTH HIGH PROFILE BOOST IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20463867 ↗