MENTOR MemoryGel BOOST Breast Implant SMPB545Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317026938), received between Oct 13, 2022 and Dec 31, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 23935579 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 325CC (LEFT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND A 545CC (RIGHT) MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2 ON THE RIGHT AND BAKER GRADE 3 ON THE LEFT) POST-OPERATIVELY. THE PATIENT HAS BEEN GIVEN A LEUKOTRINE INHIBITOR AND HAS BEEN INSTRUCTED TO PERFORM BREAST MASSAGING. ON THE LEFT SIDE, THERE IS SOME VISIBLE DISTORTION. 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

  MAUDE report 22340882 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE AND A RUPTURE (DUE TO PHYSICAL TRAUMA) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21691823 ↗
• InjuryMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE AND A RUPTURE (DUE TO PHYSICAL TRAUMA) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21691822 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PLACED EXPERIENCED LEFT SIDED ANISOMASTIA POST PROCEDURE. THE PATIENT HAD A CONCAVE SPOT IN THAT AREA. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024. THIS WAS THE THIRD SURGERY IN A SERIES OF SEVERAL BREAST SURGERIES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21324352 ↗
• InjuryFeb 5, 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 RECONSTRUCTION REVISION WITH 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THERE IS A RED MARK THAT TURNED INTO WRINKLING, ASYMMETRY, LACK OF PROJECTION, BULGING SIDES, HEMATOMA, AND LOOSE SKIN. COMPUTED TOMOGRAPHY REVEALED UNIDENTIFIED MARKS AROUND THE BREASTS THAT COULD POSSIBLY BE SUTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 21315808 ↗
• InjuryFeb 5, 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 RECONSTRUCTION REVISION WITH 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THERE IS A RED MARK THAT TURNED INTO WRINKLING, ASYMMETRY, LACK OF PROJECTION, BULGING SIDES, HEMATOMA, AND LOOSE SKIN. COMPUTED TOMOGRAPHY REVEALED UNIDENTIFIED MARKS AROUND THE BREASTS THAT COULD POSSIBLY BE SUTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 21315807 ↗
• InjurySep 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 545CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20247583 ↗
• InjurySep 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 A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20148551 ↗
• InjuryMay 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19392759 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PLACED 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 19130221 ↗
• InjurySep 5, 2023Adverse 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 545CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT 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 17685441 ↗
• InjuryJul 12, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED PROLONGED SURGERY DUE TO A DELIVERY SERVICE ISSUE WITH A 530CC AND 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT. THE PHYSICIAN CONFIRMED THAT THE PROLONGED PROCEDURE INCREASED RISK TO THE PATIENT AS SHE WAS KEPT UNDER ANESTHESIA LONGER THAN INTENDED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309388 ↗
• InjuryMay 25, 2023Migration; Migration

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC AND EXPERIENCED SWELLING/PAIN AND DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Local Reaction

  MAUDE report 17005092 ↗
• MalfunctionMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461602 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT AND BAKER GRADE III ON THE RIGHT POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15766145 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15602303 ↗