MENTOR MemoryGel BOOST Breast Implant SMHB330Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10081317031250), received between Aug 5, 2024 and Sep 28, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916482 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50857270 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BOOST 330CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE REPLACEMENT WITH CAT: SMHB330 ON (B)(6) 2025. THE PATIENT CURRENT EVENT REPORTED UNDER MANUFACTURER REPORT NUMBER: 1645337-2026-01050.

  Patient problems: Capsular Contracture

  MAUDE report 24316412 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BOOST 330-CC SILICONE IMPLANTS PRESENTED WITH BILATERAL GRADE IV CAPSULAR CONTRACTURE, HYPERTROPHIC SCARRING OF BOTH BREASTS, AND A POSTOPERATIVE RIGHT-SIDED PERIPROSTHETIC FLUID COLLECTION; THESE ISSUES WERE DIAGNOSED BASED ON HER PRESENTING SYMPTOMS, AND ON (B)(6) 2026 SHE UNDERWENT BILATERAL EXPLANTATION WITH CAPSULECTOMY AND REVISION MASTOPEXY, WITH THE TREATING CLINICIAN ADVISING AGAINST IMMEDIATE RE-IMPLANTATION AND RECOMMENDING A WAITING PERIOD OF AT LEAST THREE MONTHS BEFORE CONSIDERING REPLACEMENT. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 24253478 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BOOST 330-CC SILICONE IMPLANTS PRESENTED WITH BILATERAL GRADE IV CAPSULAR CONTRACTURE, HYPERTROPHIC SCARRING OF BOTH BREASTS, AND A POSTOPERATIVE RIGHT-SIDED PERIPROSTHETIC FLUID COLLECTION; THESE ISSUES WERE DIAGNOSED BASED ON HER PRESENTING SYMPTOMS, AND ON (B)(6) 2026 SHE UNDERWENT BILATERAL EXPLANTATION WITH CAPSULECTOMY AND REVISION MASTOPEXY, WITH THE TREATING CLINICIAN ADVISING AGAINST IMMEDIATE RE-IMPLANTATION AND RECOMMENDING A WAITING PERIOD OF AT LEAST THREE MONTHS BEFORE CONSIDERING REPLACEMENT. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture; Scar Tissue

  MAUDE report 24253222 ↗
• InjuryJun 30, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE, RIGHT BREAST IMPLANT MALPOSITION, AND LOWER POLE STRETCHING OF THE RIGHT SIDE AGGRAVATING THE ASYMMETRY CAUSED BY THE LEFT CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22359197 ↗
• InjuryJun 11, 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 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22185679 ↗
• InjuryMay 30, 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 AUGMENTATION WITH A 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE AND HEMATOMA POST PROCEDURE. THIS WAS ACCOMPANIED BY PAIN AND DISPLACEMENT. AS A RESULT, REPLACEMENT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 22114856 ↗
• InjuryMay 27, 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 REVISION SURGERY WITH IMPLANTATION OF A 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22088240 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22048296 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22048295 ↗
• InjuryApr 21, 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 PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 330CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21874810 ↗
• InjuryAug 5, 2024Adverse 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 330CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19910417 ↗