MENTOR MemoryGel BOOST Breast Implant SMHB355Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10081317031267), received between Sep 18, 2024 and Sep 29, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (5 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  It was reported that a patient underwent breast augmentation revision with a 355cc MENTOR MemoryGel BOOST Breast Implant on the right breast. Post-operatively, the patient was diagnosed, via ultrasonography, with right breast implant rupture. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement device was a Mentor gel implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936374 ↗
• InjurySep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50597585 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 57-year-old Caucasian female patient underwent a primary breast augmentation with a 355cc 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. As a result, the patient underwent explantation on (b)(6) 2026,

  Patient problems: Capsular Contracture

  MAUDE report 50015461 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24527174 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED THE FOLLOWING SYMPTOMS, BLADDER PAIN, DRY EYES, VAGINAL DRYNESS, THYROID ISSUES, HAIR LOSS, BRAIN FOG. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24478464 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH SYSTEMIC B-CELL LYMPHOMA. AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE RIGHT SIDE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Lymphoma

  MAUDE report 24421825 ↗
• InjuryJan 22, 2026Material Rupture; Air/Gas in Device

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH SMOOTH MOD HIGH BOOST, 355 CC AND EXPERIENCED BREAST IMPLANT RUPTURE, AND SQUEAKING SOUND IN HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24153103 ↗
• InjuryDec 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION, AS PART OF A CLINICAL STUDY, WITH TWO 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH B-CELL LYMPHOMA. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Lymphoma

  MAUDE report 23903656 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 355CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA AP PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 340CC GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23589265 ↗
• MalfunctionNov 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS RUPTURED DURING A BREAST SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478423 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BOOST BREAST IMPLANT 355CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE II IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 375CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23460153 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23408428 ↗
• InjuryApr 21, 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 A 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21874074 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT HAS STATED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 355 CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE OF AN UNKNOWN GRADE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR AN ANTICIPATED DATE FOR THE EXPLANTATION PROCEDURE.

  Patient problems: Capsular Contracture

  MAUDE report 21084770 ↗
• InjuryJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21057041 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 355CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 20894661 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20249345 ↗