MENTOR MemoryGel BOOST Breast Implant SMHB470Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10081317031137), received between Jun 4, 2024 and Sep 24, 2026 — classified as 19 injuries.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 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 and replacement.

  Patient problems: Capsular Contracture

  MAUDE report 50884973 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 24676510 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BREAST ASYMMETRY ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026. THE LEFT BREAST PROSTHESIS WAS NOT REPLACED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24641259 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23829251 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23829248 ↗
• InjuryDec 16, 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 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23815649 ↗
• InjuryDec 16, 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 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23815647 ↗
• InjuryNov 17, 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 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23573669 ↗
• InjuryNov 17, 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 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23570513 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 27-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 470 CC AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE II/III ON HER LEFT 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) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23465506 ↗
• InjuryOct 27, 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 PROSTHESIS IMPLANTATION SURGERY WITH A 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE RIGHT BREAST, DEVELOPED RIGHT BREAST SUPERFICIAL ABSCESS, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS ANOTHER MENTOR GEL IMPLANT.

  Patient problems: Abscess

  MAUDE report 23398799 ↗
• InjuryJun 17, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 470CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. THIS WAS DISCOVERED DURING REPLACEMENT. REPLACEMENT WITH A NEW MENTOR GEL BOOST IMPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22248094 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 470 CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22193980 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 470 CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22193978 ↗
• InjuryMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 470CC SMOOTH MOD HIGH BOOST, 470 CC AND EXPERIENCED BREAST IMPLANT RUPTURE, WOUND INFECTION, AND CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Post Operative Wound Infection

  MAUDE report 22065723 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY INVOLVING, MENTOR MEMORYGEL, BOOST 475CC, SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POST-OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PATIENTS' SYMPTOMS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21929578 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 470 CC AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III HER RIGHT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21651759 ↗
• InjuryDec 28, 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 470CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21032039 ↗
• InjuryJun 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 470CC GEL BREAST PROSTHESIS DEVELOPED A HEMATOMA IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 470CC GEL BREAST PROSTHESIS ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED BREAST PROSTHESIS WAS RUPTURED.

  Patient problems: Hematoma

  MAUDE report 19464233 ↗