MENTOR MemoryGel BOOST Breast Implant SMPB675Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317026969), received between Dec 28, 2022 and Feb 19, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL PTOSIS ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE IV AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24391176 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 23731867 ↗
• InjuryJan 23, 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 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND POSSIBLE LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024. THE LEFT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2024-14583. ON JANUARY 6, 2025, MENTOR RECIEVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES.

  Patient problems: Capsular Contracture

  MAUDE report 21218835 ↗
• InjuryDec 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE AND POSSIBLE LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20931921 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED ANISOMASTIA ON THE LEFT SIDE POST-OPERATIVELY WHICH REQUIRED SURGICAL INTERVENTION TO TREAT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20334514 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20152136 ↗
• InjuryApr 1, 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 IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 675CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19013535 ↗
• MalfunctionSep 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WAS FOUND TO HAVE A DARK SPOT ON THE IMPLANT PRIOR TO THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789950 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DISRUPTION OF THE INFRAMAMMARY INCISION AND VISIBLE EXPOSURE OF THE IMPLANT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 675CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Pocket Erosion

  MAUDE report 16061289 ↗