MENTOR MemoryGel BOOST Breast Implant SHPB635Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00081317027126), received between Nov 10, 2022 and Sep 21, 2026 — classified as 30 injuries, 4 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 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Material Rupture

  It was reported that a 47-year-old female patient underwent primary breast reconstruction surgery with 635cc MENTOR MemoryGel BOOST Breast Implant and experienced breast implant rupture on her right side postoperatively. As a result, the patient underwent replacement surgery on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845996 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24955914 ↗
• InjuryMar 9, 2026Adverse 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 GEL BREAST PROSTHESIS NOTICED A LUMP ON HER LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 24547588 ↗
• MalfunctionJan 27, 2026Material Rupture

  IT WAS REPORTED THAT A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS RUPTURED AND THE SHELL CAME OFF DURING A SIZE EXCHANGE BREAST AUGMENTATION REVISION SURGERY WHILE ATTEMPTING TO IMPLANT THE DEVICE INTO THE PATIENT'S POCKET. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189448 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR GEL BREAST PROSTHESES DEVELOPED SKIN ISSUES ON THE BREASTS POST IMPLANTATION. INGREDIENTS LIST FOR THE BREAST PROSTHESES WAS REQUESTED. ADDITIONALLY, PATIENT¿S DERMATOLOGIST WANTS TO DO PATCH TESTING. THE PATIENT HAS BLISTERS ON HER BREASTS. 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: Skin Inflammation/ Irritation

  MAUDE report 23949412 ↗
• InjuryDec 11, 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 CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT 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 23780560 ↗
• InjuryNov 26, 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 CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23659419 ↗
• 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 A 635 CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23039016 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED PAIN, FATIGUE, WEIGHT GAIN, AND INFLAMMATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22385970 ↗
• InjuryJun 27, 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 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III-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 22349470 ↗
• InjuryJun 25, 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 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 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 22329485 ↗
• InjuryMay 30, 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 635CC 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) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22115653 ↗
• InjuryApr 2, 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 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT 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 21753320 ↗
• InjuryMar 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BREASTS THAT WERE NOT SITTING UNIFORMED ANYMORE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, IT WAS DISCOVERED THAT THE RIGHT BREAST IMPLANT HAD RUPTURED. SUBSEQUENTLY, THE IMPLANTS WERE REPLACED WITH THE FOLLOWING: 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SHPB685). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21724573 ↗
• InjuryMar 28, 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 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BREASTS THAT WERE NOT SITTING UNIFORMED ANYMORE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, IT WAS DISCOVERED THAT THE RIGHT BREAST IMPLANT HAD RUPTURED. SUBSEQUENTLY, THE IMPLANTS WERE REPLACED WITH THE FOLLOWING: 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG: SHPB685). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21724567 ↗
• InjuryFeb 20, 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 635CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 635CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21429035 ↗
• InjuryJan 2, 2025Adverse 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 IMPLANTATION OF A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL 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

  MAUDE report 21063764 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT ONE IS SMALLER THAN THE OTHER. THE HEALTHCARE PROVIDER INFORMED THAT THE BREAST PROSTHESIS WAS NOT RUPTURED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21027780 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BOOST BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH THE PROCEDURE OUTCOME 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 20919635 ↗
• MalfunctionOct 18, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO IMPLANTATION, A MENTOR MEMORYGEL BOOST BREAST IMPLANT 635CC WAS FOUND TO HAVE A SHELL DEFECT. THE DEVICE WAS NOT IMPLANTED, AND THERE WERE NO REPORTED DELAYS IN SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482380 ↗
• InjurySep 30, 2024Adverse 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 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). THIS IS CHARACTERIZED BY BREAST PAIN ALSO. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20339436 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT AND EXPERIENCED BREAST INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20214360 ↗
• InjurySep 12, 2024Migration; Migration

  IT WAS REPORTED THAT A 35-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT REPORTED THAT SHE NOTICED IN JANUARY THAT ONE BREAST WAS DIFFERENT THEN THE OTHER AND WENT TO A SURGEON ON THE (B)(6) AND HE GAVE THE DIAGNOSIS. ON (B)(6) 2024, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED LEFT SIDE DEVICE MIGRATION IN ADDITION TO RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III/IV. 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-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20208228 ↗
• MalfunctionMar 5, 2024Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT BEING USED IN A BREAST RECONSTRUCTION REVISION WAS FOUND TO HAVE A LARGE CREASE ACROSS THE SHELL DURING THE OPERATION. THE SURGEON WAS USING BREAST PROSTHESIS AS A SIZER AND INSERTING THE BREAST PROSTHESIS WITH FORCE INTO THE BREAST POCKET. THE BREAST PROSTHESIS WAS PUSHED FROM SIDE TO SIDE INTO THE INCISION. THE RETRACTOR WAS ALSO IN THE INCISION WHEN INSERTING THE BREAST PROTHESIS. THE SURGEON NOTICED UPON REMOVING THE BREAST PROSTHESIS FROM THE POCKET THAT IT WAS POSSIBLY FRACTURED ON THE INSIDE. THERE WAS A LARGE CREASE RUNNING ACROSS THE SHELL, HOWEVER, THE SHELL WAS INTACT, AND NO RUPTURE WAS VISIBLE. 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 18842469 ↗
• InjuryDec 20, 2023Adverse 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 626CC MENTOR MEMORYGEL BOOST BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3-4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18368657 ↗