MENTOR MemoryGel BOOST Breast Implant SMHB700Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10081317031304), received between Mar 3, 2025 and Feb 5, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24269107 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED HASHIMOTO'S THYROIDITIS FLARE, SYSTEMIC INFLAMMATION, MAST CELL ACTIVATION SYNDROME, ORAL ALLERGY SYNDROME, INCREASED AUTOIMMUNE ACTIVITY, AND POSITIVE ANA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 23528931 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED HASHIMOTO'S THYROIDITIS FLARE, SYSTEMIC INFLAMMATION, MAST CELL ACTIVATION SYNDROME, ORAL ALLERGY SYNDROME, INCREASED AUTOIMMUNE ACTIVITY, AND POSITIVE ANA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 23528930 ↗
• MalfunctionOct 27, 2025Material Deformation; Material Deformation

  A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BOOST 700CC SILICONE IMPLANTS. INTRAOPERATIVELY, IRREGULARITIES OF THE LEFT IMPLANT SHELL WERE NOTED; THE DEVICE DID NOT HOLD ITS SHAPE DURING IMPLANTATION AND APPEARED WRINKLED AND DEFLATED. THE IMPLANT WAS NOT RUPTURED, BUT SINCE IT COULD NOT MAINTAIN ITS SHAPE, IT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394593 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST 700CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT. PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22650355 ↗
• InjuryMar 3, 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 AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. VISION CHANGES, WEIGHT GAIN, SWELLING, BREAST PAIN, AND JOINT PAIN WERE NOTED. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21509845 ↗
• InjuryMar 3, 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 AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. VISION CHANGES, WEIGHT GAIN, SWELLING, BREAST PAIN, AND JOINT PAIN WERE NOTED. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21509844 ↗