MENTOR MemoryGel BOOST Breast Implant SMPB480Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00081317026914), received between Oct 31, 2022 and Sep 29, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50933898 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 59-year-old Caucasian female patient underwent revision breast augmentation with 480cc MENTOR MemoryGel BOOST Breast Implant and experienced Capsular Contracture; Baker Grade III on her left side; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the patient underwent replacement surgery with unknown gel devices on (b)(6)2026.

  Patient problems: Capsular Contracture

  MAUDE report 50690517 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT NECESSITATING REMOVAL ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 25033833 ↗
• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH BILATERAL RUPTURE 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24730109 ↗
• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH BILATERAL RUPTURE 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24729042 ↗
• InjuryFeb 24, 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 EXPERIENCED RIGHT BREAST PAIN AND WAS SUBSEQUENTLY DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE USING AN UNDISCLOSED IMAGING METHODOLOGY. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24433648 ↗
• InjuryFeb 10, 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 WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24308830 ↗
• InjuryJan 20, 2026Appropriate Device Problem Term/Code Not Available; Migration

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST 480CC ON THE RIGHT, AND 430CC ON THE LEFT SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE, AND LEFT SIDE DEVICE MIGRATION AND BUBBLES POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAPSULECTOMIES AND BILATERAL REPLACEMENTS PER FOLLOWING: L) REF: SMPB530 SN: (B)(6), R) REF: SMPB530 SN: (B)(6) ON (B)(6) 2025. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24125974 ↗
• InjuryDec 30, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BOOST 480CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: L) REF: SMPB530 SN: (B)(6), R) REF: SMPB530 SN:(B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23926491 ↗
• InjuryDec 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 FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. THE PATIENT REPORTED THE BREAST BEING HIGH AND FIRM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23896919 ↗
• InjuryNov 18, 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 BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 185CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23588713 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22797173 ↗
• InjuryAug 4, 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 DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE I-II ON THE LEFT AND BAKER GRADE III ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22700269 ↗
• InjuryAug 4, 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 DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE I-II ON THE LEFT AND BAKER GRADE III ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22700266 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21587032 ↗
• InjuryJan 7, 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 480CC 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 21093741 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS EXPERIENCED UNSPECIFIED COMPLICATIONS REQUIRING REMOVAL ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20939460 ↗
• InjuryDec 6, 2024Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480 CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III-IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20867148 ↗
• InjuryJun 12, 2024Adverse 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 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT A UNILATERAL CAPSULECTOMY AND IMPLANT EXCHANGE OF HER RIGHT PROSTHESIS ON (B)(6) 2024. THE IDENTITY OF THE REPLACEMENT DEVICE HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Capsular Contracture

  MAUDE report 19524220 ↗
• MalfunctionMay 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT RUPTURED, INTRA-OPERATIVELY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT. ANOTHER 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SMPB480 LOT: 9976212 SN: (B)(6), WAS IMPLANTED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222314 ↗
• InjuryApr 15, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19112658 ↗
• InjuryApr 4, 2024Material Discolored; Material Discolored

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESIS THAT WAS SUSPECTED TO BE RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A CT SCAN. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESIS ON (B)(6) 2024. DURING EXPLANT SURGERY, ABOUT 150 ML OF DARK SEROUS FLUID CONSISTENT WITH LIQUEFIED HEMATOMA WAS OBSERVED IN THE RIGHT BREAST. RESULTS FROM PATHOLOGY/CYTOLOGY HAVE NOT BEEN PROVIDED. ADDITIONALLY, IT WAS OBSERVED THAT THE DEVICE WAS REMOVED INTACT, BUT THE GEL INSIDE WAS NOTED TO BE CLOUDY.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 19047535 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SHPB775; SERIAL NUMBER (B)(6), ON THE LEFT SIDE, AND WITH CATALOG NUMBER SHPB775; SERIAL NUMBER (B)(6), ON THE RIGHT SIDE ON (B)(6) 2023. ON (B)(6) 2024, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED POOR CLEAVAGE AND PTOSIS IN ADDITION TO LEFT SIDE RUPTURE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18918520 ↗
• InjuryMar 11, 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 BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(4).

  Patient problems: Capsular Contracture

  MAUDE report 18879035 ↗
• InjuryFeb 21, 2024Adverse 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 A 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18748998 ↗