MENTOR MemoryGel BOOST Breast Implant SHPB480Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00081317027089), received between Apr 29, 2022 and Sep 23, 2026 — classified as 55 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 480cc MENTOR MemoryGel BOOST Breast Implant experienced hypersensitivity post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50870006 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 480cc MENTOR MemoryGel BOOST Breast Implant experienced hypersensitivity post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50870004 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 480cc MENTOR MemoryGel BOOST Breast Implants. Post-operatively, the patient was diagnosed, via physical examination, with right breast capsular contracture (baker grade IV). As a result, the patient underwent breast implant removal surgery on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50863622 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 40-year-old Hispanic female patient underwent a breast augmentation revision with a 480cc MENTOR MemoryGel BOOST Breast Implant and experienced capsular contracture (baker grade 3) on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 480cc MENTOR MemoryGel BOOST Breast Implant.

  Patient problems: Capsular Contracture

  MAUDE report 50808624 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25305905 ↗
• InjuryMay 11, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE, BILATERAL DEVICE MIGRATION, AND BILATERAL ANIMATION DEFORMITY POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THE LEFT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2026-03767. ON (B)(6) 2026 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25136316 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 25071656 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 25071449 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24905194 ↗
• InjuryMar 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24662802 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE 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.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 24333944 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24280549 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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; Nipple Sensation Changes

  MAUDE report 24036841 ↗
• InjuryJan 8, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE WITH PAIN AND BOTTOMING OUT OF THE RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL EXCHANGE WITH MENTOR IMPLANTS ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24014470 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE WITH PAIN AND BOTTOMING OUT OF THE RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL EXCHANGE WITH MENTOR IMPLANTS ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24014465 ↗
• InjuryNov 3, 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 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23457676 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23035104 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST, 480CC ON THE RIGHT, AND 470CC ON THE LEFT SIDE SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV, AND RIGHT SIDED UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH IN OFFICE EXAMINATION. AS A RESULT, PATIENT UNDERWENT LEFT SIDED CAPSULECTOMY, AND REPLACEMENT WITH L: (B)(6) / SHPB480 ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 22666466 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS WERE NOT PERFORMED PER THE HEALTHCARE PROFESSIONAL'S REQUEST.

  Patient problems: Capsular Contracture

  MAUDE report 22572284 ↗
• InjuryMay 14, 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 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (LEFT) AND A 520CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (RIGHT) EXPERIENCED CELLULITIS BILATERAL POST PROCEDURE. THIS WAS RECURRENT ON THE RIGHT SIDE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH A FEVER, REDNESS, AND PAIN. DRAINS WERE PLACED TO REMOVE FLUID. AS A RESULT, EXPLANT WITHOUT REPLACEMENT WAS PERFORMED ROUGHLY ONE WEEK LATER.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22021284 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21880192 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 480CC 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) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21766280 ↗
• MalfunctionMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED FOR BREAST SURGERY RUPTURED INTRAOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645193 ↗
• InjuryMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THIS WAS DISCOVERED DURING EXPLANT. REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6), 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21579533 ↗
• InjuryFeb 7, 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 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED TO A FOLLOW-UP VISIT WITH A MEDICAL PROFESSIONAL AS SHE WAS EXPERIENCING ASYMMETRY DUE TO AN ENLARGED LEFT BREAST AND LEFT BREAST IMPLANT MALPOSITION. THE LEFT BREAST WAS ELEVATED AND SORE AT TIMES. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR UNILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21337852 ↗