MENTOR MemoryGel BOOST Breast Implant SMPB290Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00081317026853), received between Jan 9, 2023 and Sep 16, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

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

  It was reported that a patient implanted with a 290cc MENTOR MemoryGel BOOST Breast Implant experienced capsular contracture Baker Grade 3-4 on the right side post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50791341 ↗
• MalfunctionApr 14, 2026Material Deformation

  A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A MENTOR MEMORYGEL BOOST 290 CC SILICONE PROSTHESIS WAS IDENTIFIED INTRAOPERATIVELY WITH A DEFORMED DEVICE (SIDE UNKNOWN). DURING INSERTION OF A 290 CC BOOST MODERATE PLUS IMPLANT, THE DEVICE REPEATEDLY DISENGAGED FROM THE FUNNEL. INSPECTION IDENTIFIED A PRONOUNCED INDENTED CREASE ACROSS THE SUPERIOR ASPECT OF THE IMPLANT MANUAL MANIPULATION AND A REST PERIOD DID NOT RESOLVE THE CREASE. ALTHOUGH PARTIAL IMPROVEMENT WAS LATER NOTED ON THE BACK TABLE, THE DEVICE WAS NOT USED DUE TO CONCERN FOR POTENTIAL RUPTURE OR OTHER INTEGRITY ISSUES. A BACKUP IMPLANT WAS USED. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879086 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES POSSIBLY DEVELOPED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE IS SUSPECTED, BUT NOT CONFIRMED. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24634126 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 290CC 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) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24629944 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES POSSIBLY DEVELOPED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE IS SUSPECTED, BUT NOT CONFIRMED. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24627911 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPOSURE OF THE RIGHT BREAST IMPLANT WHICH NEEDED TO BE REMOVED AND REPLACED WITH DEBRIDEMENT ON (B)(6) 2024.

  Patient problems: Necrosis; Pocket Erosion

  MAUDE report 24506328 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL ANIMATION DEFORMITIES. THE ISSUES WERE DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 24327949 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL ANIMATION DEFORMITIES. THE ISSUES WERE DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 24327944 ↗
• InjuryDec 5, 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 RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV (LEFT-SIDED) AND III (RIGHT-SIDED) CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. 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 23735348 ↗
• MalfunctionSep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066093 ↗
• InjuryJun 9, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 290CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. CAPSULAR CONTRACTURE WAS DIAGNOSED DURING 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

  MAUDE report 22172560 ↗
• InjuryJun 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 WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22133907 ↗
• InjuryApr 21, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 290CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION IN (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21875425 ↗
• InjuryNov 27, 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 MENTOR MEMORYGEL BOOST BREAST IMPLANT 290CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20803076 ↗
• InjuryNov 27, 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 MENTOR MEMORYGEL BOOST BREAST IMPLANT 290CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6)2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20803075 ↗
• InjuryNov 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 BREAST AUGMENTATION WITH A 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED RIGHT SIDED WRINKLING POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Wrinkling

  MAUDE report 20653732 ↗
• InjuryAug 6, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19920700 ↗
• InjuryAug 6, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19920322 ↗
• InjuryMay 13, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 290CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6), 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19305517 ↗
• InjuryApr 24, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 290CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-04879 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19175836 ↗
• InjuryApr 24, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BOOST BREAST IMPLANTS 290CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-04880 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19175827 ↗
• InjuryNov 20, 2023Migration; Migration

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE DATE OF REPLACEMENT SURGERY WITH NON-MENTOR DEVICES IS (B)(6) 2023. ON (B)(6) 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED DEVICES FOR EVALUATION. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED RIGHT SIDE DEVICE MALPOSITION IN ADDITION TO LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18172158 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 26-YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17084144 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO MENTOR MEMORYGEL BOOST BREAST IMPLANTS WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB UNDER AN UNRELATED COMPLAINT. THE DEVICES COULD NOT BE ASSOCIATED WITH ANY EXISTING COMPLAINTS AFTER MULTIPLE ATTEMPTS FOR CLARIFICATION. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 17012650 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3-4) AND PARESTHESIA ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. THE PATIENT MENTIONED FEELING PINS AND NEEDLE SENSATIONS. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 16280815 ↗