MENTOR MemoryGel Breast Implant 3501254BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317000396), received between Sep 12, 2019 and Feb 17, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24361420 ↗
• InjuryFeb 13, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 125CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24334460 ↗
• InjuryMar 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE REPLACEMENT SURGERY WITH SERIAL NUMBER (B)(6) ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21536607 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3544300 LOT: 9984266 SN: (B)(6) AND (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3544300 LOT: 9984266 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20327744 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3544300 LOT: 9984266 SN: (B)(6) AND (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3544300 LOT: 9984266 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20327614 ↗
• InjuryJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 125CC AND EXPERIENCED RUPTURE 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: Deformity/ Disfigurement

  MAUDE report 19520291 ↗
• InjuryJun 11, 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 SURGERY WITH 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6), 2024. NO DATE OF IMPLANTATION WAS PROVIDED. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 19515301 ↗
• InjuryJun 11, 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 SURGERY WITH 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2024. NO DATE OF IMPLANTATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 19515298 ↗
• InjuryMar 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS LEAKAGE IN THE RIGHT BREAST PROSTHESIS. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN THE RIGHT BREAST POST IMPLANTATION. THE RIGHT BREAST IS HARD AND ¿LUMPIER¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18828311 ↗
• InjuryFeb 15, 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 A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18718182 ↗
• InjuryJan 13, 2024Adverse 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 A 125CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18509568 ↗
• InjuryNov 8, 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 TWO 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18096645 ↗
• InjuryNov 8, 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 TWO 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18096644 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. 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: Deformity/ Disfigurement

  MAUDE report 17439038 ↗
• InjuryJul 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17368625 ↗
• InjuryNov 16, 2022Adverse 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 FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15811018 ↗
• InjuryOct 18, 2022Adverse 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 WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 175CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (RIGHT) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15628814 ↗
• InjuryOct 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15566361 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT¿S LEFT BREAST HAD MIGRATED TO THE UPPER LEFT POLE WITH LEFT BREAST PAIN. AFTER A PHYSICAL EXAM AND ULTRASOUND IMAGING, SHE WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14940133 ↗
• InjuryApr 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS DEVELOPED PAIN IN HER LEFT BREAST POST IMPLANTATION. THE PATIENT ALSO NOTICED A LUMP ON HER LEFT BREAST AND THAT IT APPEARED DISFIGURED. A MAMMOGRAM AND ULTRASOUND SHOWED THAT THERE WAS A SLOW LEAK FROM THE LEFT BREAST PROSTHESIS, INDICATING RUPTURE OF THE DEVICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 14164497 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT AND 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 13426389 ↗
• InjuryJan 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURE TO THE RIGHT BREAST PROSTHESIS BY AN UNKNOWN METHODOLOGY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AT AN UNDISCLOSED TIME.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13184032 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE). THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2019.

  Patient problems: Capsular Contracture

  MAUDE report 12207974 ↗
• InjuryJun 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD WHITE HISPANIC FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION PROCEDURES (REVISION FOR LEFT BREAST, PRIMARY FOR RIGHT BREAST) WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). IT WAS REPORTED THAT THE PATIENT¿S LEFT BREAST TRIPLED IN SIZE AND IS PUSHING INTO HER UNDERARM. THE RIGHT BREAST IS SMALL AND TIGHT. ADDITIONALLY, THE PATIENT IS SUFFERING FROM CHEST PAIN THAT TRAVELS FROM FRONT TO BACK AND PAIN UNDERNEATH BOTH BREASTS AROUND THE RIB CAGE. WHEN SHE MOVES OR TWISTS, SHE FEELS SHOOTING PAIN. LASTLY, THE PATIENT¿S RIGHT BREAST PROSTHESIS POSSIBLY RUPTURED. THE RIGHT BREAST IS SMALLER AND FLATTER. 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; Skin Inflammation/ Irritation

  MAUDE report 11988772 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 125 CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE AND WITH 175 CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE ON (B)(6) 2011. NOW THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND RIGHT SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY. 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: Capsular Contracture

  MAUDE report 11738075 ↗