MENTOR MemoryGel BOOST Breast Implant SMPB235Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317026839), received between Oct 24, 2023 and Mar 3, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND WAS DIAGNOSED WITH BREAST CANCER AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE POST-OPERATIVELY. BASED ON THE INFORMATION AVAILABLE, THE EVENT WAS CHARACTERIZED BY A DUCTAL CARCINOMA IN SITU OF THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH AN 185CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Breast Cancer; Capsular Contracture

  MAUDE report 24497826 ↗
• InjuryDec 1, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 235CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23689134 ↗
• InjuryNov 4, 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 III-IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Capsular Contracture

  MAUDE report 23471845 ↗
• InjuryAug 15, 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 A 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22813150 ↗
• InjuryJul 29, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4 ON THE RIGHT SIDE AND BAKER GRADE 2-3 ON THE LEFT SIDE) AND BILATERAL ANIMATION DEFORMITY POST-OPERATIVELY. THE PATIENT REPORTED HAVING PAIN AND THAT THE RIGHT IMPLANT SITS HIGHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22654966 ↗
• InjuryJul 29, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4 ON THE RIGHT SIDE AND BAKER GRADE 2-3 ON THE LEFT SIDE) AND BILATERAL ANIMATION DEFORMITY POST-OPERATIVELY. THE PATIENT REPORTED HAVING PAIN AND THAT THE RIGHT IMPLANT SITS HIGHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22654791 ↗
• 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 BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT WAS SCHEDULED FOR A RIGHT-SIDED CAPSULOTOMY PROCEDURE WITHOUT REMOVAL OF THE IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 22184536 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17996845 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 235CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17996844 ↗