MENTOR MemoryGel BOOST Breast Implant SMPB185Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317026815), received between Apr 7, 2023 and Dec 12, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23791093 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL, BOOST 185CC SILICONE PROSTHESES DEVELOPED BILATERAL CAPSULAR CONTRACTURE GRADE IV, DIAGNOSED THROUGH PHYSICAL EXAMINATION DUE TO PROGRESSIVELY WORSENING BREAST PAIN OVER SEVERAL YEARS. SHE REPORTED SEVERE, PERSISTENT PAIN IN HER NECK, BACK, AND BREASTS, EXACERBATED BY ARM MOVEMENTS, EXERCISE, AND DAILY ACTIVITIES, SIGNIFICANTLY IMPACTING HER QUALITY OF LIFE DESPITE CONSERVATIVE TREATMENTS, INCLUDING NSAIDS AND PHYSICAL THERAPY. ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY TO ADDRESS CAPSULAR CONTRACTURE, IN HOPES OF ALLEVIATING HER DEBILITATING SYMPTOMS. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21304007 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL, BOOST 185CC SILICONE PROSTHESES DEVELOPED BILATERAL CAPSULAR CONTRACTURE GRADE IV, DIAGNOSED THROUGH PHYSICAL EXAMINATION DUE TO PROGRESSIVELY WORSENING BREAST PAIN OVER SEVERAL YEARS. SHE REPORTED SEVERE, PERSISTENT PAIN IN HER NECK, BACK, AND BREASTS, EXACERBATED BY ARM MOVEMENTS, EXERCISE, AND DAILY ACTIVITIES, SIGNIFICANTLY IMPACTING HER QUALITY OF LIFE DESPITE CONSERVATIVE TREATMENTS, INCLUDING NSAIDS AND PHYSICAL THERAPY. ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY TO ADDRESS CAPSULAR CONTRACTURE, IN HOPES OF ALLEVIATING HER DEBILITATING SYMPTOMS. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21286050 ↗
• InjuryJun 18, 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 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. CAPSULAR CONTRACTURE ON THE RIGHT BREAST HAS BEEN REPORTED UNDER MRN: 1645337-2024-06658.

  Patient problems: Capsular Contracture

  MAUDE report 19558987 ↗
• InjuryJun 4, 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 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19462107 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED, AND REPLACED ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16702520 ↗