MENTOR MemoryGel BOOST Breast Implant SMPB590Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317026945), received between Sep 28, 2022 and Jul 15, 2025 — classified as 12 injuries, 3 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 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 PAIN, MILD NUMBNESS, AND SLIGHT WEAKNESS ON THE RIGHT SIDE BELIEVED TO BE THE START OF BRACHIAL PLEXUS IRRITATION. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Pain; Paresthesia

  MAUDE report 22509998 ↗
• InjuryApr 30, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. UPON EXPLANTATION, THE DEVICE WAS FOUND TO BE DISCOLORED.

  Patient problems: Capsular Contracture

  MAUDE report 21935431 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE AND RIGHT SIDED PTOSIS POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, LEFT SIDED REPLACEMENT WAS AND REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE RIGHT SIDE WAS NOT EXPLANTED. THE LEFT SIDED CAPSULAR CONTRACTURE WAS REPORTED INITIALLY UNDER 1645337-2025-02408. ON (B)(6) 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21772846 ↗
• InjuryMar 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 PRIMARY BREAST AUGMENTATION WITH A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21532101 ↗
• MalfunctionNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS INSERTED INCORRECTLY (UPSIDE DOWN) DURING THE OPERATION. WHEN THE DOCTOR PULLED IT OUT WITH HIS FINGERS, THE "GEL WAS PINCHED AND DEFORMED". NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780810 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MW5158327 & MW5158328 THAT A PATIENT IMPLANTED WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED SYMPTOMS INCLUDING FATIGUE, HEADACHE, MEMORY LOSS/IMPAIRMENT, MUSCLE WEAKNESS, PAIN, VERTIGO, DEPRESSION, IRRITABILITY, VISION PROBLEM, AND BREAST PAIN POST-OPERATIVELY. 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 20303156 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MW5158327 & MW5158328 THAT A PATIENT IMPLANTED WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED SYMPTOMS INCLUDING FATIGUE, HEADACHE, MEMORY LOSS/IMPAIRMENT, MUSCLE WEAKNESS, PAIN, VERTIGO, DEPRESSION, IRRITABILITY, VISION PROBLEM, AND BREAST PAIN POST-OPERATIVELY. 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 20303154 ↗
• InjuryAug 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. UPON EXPLANTATION, THE DEVICE WAS FOUND TO HAVE BUBBLES ON THE SURFACE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20033733 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. 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 18610663 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4 ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. 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

  MAUDE report 18610662 ↗
• InjuryNov 22, 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 SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III-IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 18196551 ↗
• 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 BREAST RECONSTRUCTION REVISION WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9873994 SN: (B)(6) AND (RIGHT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9736441 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18119607 ↗
• 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 BREAST RECONSTRUCTION REVISION WITH TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9873994 SN: (B)(6) AND (RIGHT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9736441 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18119603 ↗
• MalfunctionSep 28, 2022Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND DEVICE DEFORMITY INTRA-OPERATIVELY. NO PATIENT CONSEQUENCE OR ADVERSE EVENT WAS REPORTED. NO PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499567 ↗
• MalfunctionSep 28, 2022Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT TWO 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND DEVICE DEFORMITY INTRA-OPERATIVELY. NO PATIENT CONSEQUENCE OR ADVERSE EVENT WAS REPORTED. NO PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499555 ↗