MENTOR MemoryGel BOOST Breast Implant SMPB210Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317026822), received between Nov 13, 2023 and Sep 16, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50796612 ↗
• MalfunctionAug 29, 2025Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT TWO BOXES OF MENTOR MEMORYGEL BOOST, 210CC, WERE RECEIVED BY THE CUSTOMER. TWO IMPLANTS WITH THE SAME SERIAL NUMBER ON THEIR RESPECTIVE BOXES. ONE OF THE TWO BOXES HAS A SERIAL NUMBER ON ONE SIDE OF THE BOX THAT DIFFERS FROM THE SERIAL NUMBER ON THE OPPOSITE SIDE. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922893 ↗
• MalfunctionAug 29, 2025Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT TWO BOXES OF MENTOR MEMORYGEL BOOST, 210CC, WERE RECEIVED BY THE CUSTOMER. ONE OF THE TWO BOXES HAS A SERIAL NUMBER ON ONE SIDE OF THE BOX THAT DIFFERS FROM THE SERIAL NUMBER ON THE OPPOSITE SIDE. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922541 ↗
• 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 BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 210CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21873768 ↗
• 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 BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 210CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21873766 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 210 CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL PAIN ALL OVER BODY. IT WAS REPORTED THAT THE PAIN STARTED IN THROAT AND JAW. THE ISSUE WAS DIAGNOSED OVER PHONE CALL. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Pain

  MAUDE report 21508961 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 210 CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL PAIN ALL OVER BODY. IT WAS REPORTED THAT THE PAIN STARTED IN THROAT AND JAW. THE ISSUE WAS DIAGNOSED OVER PHONE CALL. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Pain

  MAUDE report 21508880 ↗
• InjuryFeb 11, 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 210CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE AND BILATERAL UNSPECIFIED DEFORMITIES POST PROCEDURE. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON THE RIGHT SIDE, AND SURGICAL INTERVENTION WAS PERFORMED TO CORRECT THE LEFT SIDED DEFORMITY. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS REPORTED INITIALLY UNDER 1645337-2024-14247. ON (B)(6), 2025, MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21358233 ↗
• InjuryDec 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 210CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20856759 ↗
• InjuryJun 12, 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 210CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19524271 ↗
• InjuryNov 13, 2023Adverse 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 A 210CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST PTOSIS ACCENTUATED BY A TUBEROUS DEFORMITY IN THE RIGHT BREAST. IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS RIDING HIGH ALONG THE MEDIAL ASPECT OF HER BREAST. THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. 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 18121987 ↗