MENTOR MemoryGel BOOST Breast Implant SMHB580Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10081317031120), received between Jun 24, 2024 and Dec 30, 2025 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 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 580CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED INTERMITTENT RIGHT BREAST PAIN. DURING A PHYSICAL EXAM, SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23931025 ↗
• InjuryJan 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 PRIMARY BREAST RECONSTRUCTION WITH A 580CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED LOCAL REACTION POST PROCEDURE. THE DEVICE BREAST IS SWOLLEN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 21242877 ↗
• InjuryDec 9, 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 580CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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 20880909 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 580CC 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. THE HEALTHCARE PROVIDER ANTICIPATED RESTARTING THE PATIENT WITH SINGULAR AND MASSAGING PRIOR TO SURGICAL PROCEDURE. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19941100 ↗
• InjuryJun 24, 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 SURGERY WITH A 580CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19600067 ↗