MENTOR MemoryGel Breast Implant 3544275Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00081317001034), received between Mar 6, 2018 and Feb 5, 2026 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (18 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.

• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24265813 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). 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 24265812 ↗
• InjuryDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23708671 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3-4) AND LYMPHADENOPATHY 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; Swollen Lymph Nodes/Glands

  MAUDE report 21939365 ↗
• MalfunctionMar 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 275CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A PRIMARY BREAST AUGMENTATION SURGERY AT THE TIME OF IMPLANT PLACEMENT INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665142 ↗
• InjuryFeb 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3544275; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3544275; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21341146 ↗
• InjuryFeb 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3544275; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3544275; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21341145 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 275CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II, AND BILATERAL SYMPTOMATIC RUPTURES POSTOPERATIVE. THE IN-OFFICE EXAMINATION DIAGNOSED THE ISSUE, AND ULTRASOUND EXAMINATION CONFIRMED THE RUPTURES. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20707623 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 275CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II, AND BILATERAL SYMPTOMATIC RUPTURES POSTOPERATIVE. THE IN-OFFICE EXAMINATION DIAGNOSED THE ISSUE, AND ULTRASOUND EXAMINATION CONFIRMED THE RUPTURES. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20707488 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17954303 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17949765 ↗
• InjuryMay 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 275CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED UNILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE. NO ADDITIONAL EVENT DETAILS ARE AVAILABLE AT THIS TIME. IF ADDITIONAL EVENT DETAILS BECOME AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16915329 ↗
• InjuryMar 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED VIA ULTRASOUND. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2023 . ON (B)(6) 2023 , , THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, IT CANNOT BE DETERMINED WHICH DEVICE IS THE SUSPECT MEDICAL DEVICE FOR THE REPORTED RUPTURE, SINCE THE TWO RECEIVED PRODUCTS HAVE THE SAME VOLUME ENGRAVED, BOTH DEVICES WERE FOUND DAMAGED PER ANALYSIS FINDINGS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE FOUND RUPTURED UPON ANALYSIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16653196 ↗
• InjuryJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED VIA ULTRASOUND. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16244230 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES DEVELOPED SEROMA WITH SUBSEQUENT CELLULITIS IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE RIGHT BREAST PROSTHESIS ON (B)(6) 2022. THE EXPLANTED BREAST PROSTHESIS WAS NOT REPLACED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 14701295 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES DEVELOPED SEROMA WITH SUBSEQUENT CELLULITIS IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE RIGHT BREAST PROSTHESIS ON (B)(6) 2022. THE EXPLANTED BREAST PROSTHESIS WAS NOT REPLACED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 14701287 ↗
• InjuryMay 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT RUPTURE BILATERALLY COMPLICATED BY GRANULOMAS FORMATION. IT WAS ALSO REPORTED THAT THE PATIENT HAS DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENTS WERE: (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC LOT: 9672826 SN: (B)(4) AND (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC LOT: 9638031 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 14480536 ↗
• InjuryMay 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT RUPTURE BILATERALLY COMPLICATED BY GRANULOMAS FORMATION. IT WAS ALSO REPORTED THAT THE PATIENT HAS DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENTS WERE: (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 9672826, SN: (B)(4) AND (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503004BC, LOT: 9638031, SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 14480373 ↗
• InjuryApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES, GRANULOMAS, AND CAPSULAR CONTRACTURE, BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(4) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 14252993 ↗
• InjuryApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES, GRANULOMAS, AND 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; Granuloma

  MAUDE report 14252990 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST, SUFFERED A LEFT BREAST THAT GOT SWOLLEN, WITH HARDNESS UNDERNEATH, AND HAS GOTTEN WAY BIGGER THAN THE RIGHT SIDE, POST-PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 13102693 ↗
• InjuryAug 2, 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 A BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT, 275CC (LEFT), 300CC (RIGHT), AND EXPERIENCED LOOSE TISSUE ON THE BREAST BILATERALLY POST-OPERATIVELY, WHICH WAS CONFIRMED VIA 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 SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 12263542 ↗
• InjuryNov 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SPONTANEOUS BILATERAL RUPTURE RUPTURE POST PROCEDURE. THE RUPTURE WAS STATED TO BE MORE PRONOUNCED ON THE LEFT THAN THE RIGHT SIDE. AS A RESULT, EXPLANT AND REPLACEMENT WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED WAS PERFORMED ON (B)(6) 2020. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2020-12573 ON OCTOBER 5, 2020. ON NOVEMBER 4, 2020 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF THE LEFT SIDED RUPTURE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10901290 ↗
• InjuryOct 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10631972 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL 275CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE III) POST PROCEDURE. THROUGH ULTRASOUND EXAMINATION, BOTH BREASTS WERE DIAGNOSED WITH BAKER'S GRADE III. AS A RESULT, BILATERAL REPLACEMENTS WAS PERFORMED ON (B)(6) 2020. THIS REPORT BELONG TO RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10478130 ↗