MENTOR MemoryGel Breast Implant 3543607MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00081317004424), received between Jan 25, 2019 and Aug 7, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 360CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A POSSIBLE RUPTURE THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN WITH AN ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22743457 ↗
• InjuryJul 14, 2025Material 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 IMPLANTED WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22500402 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL , 360CC SILICONE PROSTHESIS EXPERIENCED BILATERAL LOCAL REACTIONS POSTOPERATIVE. THE PATIENT IS EXPERIENCING INFLAMMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Local Reaction

  MAUDE report 20559282 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 360CC SILICONE PROSTHESIS EXPERIENCED BILATERAL LOCAL REACTIONS POSTOPERATIVE. THE PATIENT IS EXPERIENCING INFLAMMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Local Reaction

  MAUDE report 20559190 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 360CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A POSSIBLE RUPTURE THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE 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 20306291 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 340CC (LEFT), 360CC (RIGHT), MENTOR MEMORYGEL BREAST IMPLANT WAS DIAGNOSED WITH LEFT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 2 POST-OPERATIVELY. IN ADDITION, A SEROMA FORMED ON THE LEFT SIDE WHICH REQUIRED SURGICAL INTERVENTION VIA NEEDLE ASPIRATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 .

  Patient problems: Capsular Contracture

  MAUDE report 19470353 ↗
• InjuryJun 2, 2023Use 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 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 360CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH SWOLLEN RIGHT-SIDED LYMPH NODES. IN ADDITION ULTRASOUND IMAGING WAS CONDUCTED, AND IT WAS SUSPECTED THAT THERE WAS A RUPTURED RIGHT BREAST IMPLANT. MAMMOGRAM IMAGING WAS CONDUCTED, AND THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT WHICH WAS COMPLICATED BY GRANULOMA FORMATION IN THE RIGHT AXILLA REGION. ADDITIONALLY, SHE WAS PREVIOUSLY DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE OF UNDISCLOSED BAKER GRADE RATINGS. AS A RESULT OF THE CONTRACTURES, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE HER BREAST CAPSULES. HOWEVER, DURING THIS PROCEDURE, THE SURGEON EXPLANTED THE DEVICES AND REINSERTED THEM. MENTOR MEMORYGEL BREAST IMPLANTS ARE NOT INTENDED FOR REUSE/REIMPLANTATION, THUS THE USER USED THE DEVICE IN ERROR. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04661 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17050328 ↗
• InjuryApr 20, 2023Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 360CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH SWOLLEN RIGHT-SIDED LYMPH NODES. IN ADDITION ULTRASOUND IMAGING WAS CONDUCTED, AND IT IS SUSPECTED THAT THERE IS A RUPTURED RIGHT BREAST IMPLANT. MAGNETIC RESONANCE IMAGING WAS RECOMMENDED TO CONFIRM THE RUPTURE AS THE SURGEON COULD NOT CONFIRM THE RUPTURE AT THE TIME. 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; Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 16778024 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 360CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN IN HER LEFT BREAST AND NOTED THAT IT FELT BUMPY. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS NOT BEEN CONDUCTED. 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 16519345 ↗
• InjuryMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A LEFT-SIDED UNSPECIFIED MENTOR GEL BREAST IMPLANT AND A 360CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS AND A POSSIBLE RUPTURE OF HER LEFT PROSTHESIS, WHICH WERE IDENTIFIED VIA MAGNETIC RESONANCE IMAGING. 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. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02751 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16516429 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 360CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE, AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND A BREAST MASS ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 15382273 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 360CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE, AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND A BREAST MASS ON THE RIGHT SIDE POST-OPERATIVELY. 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: Breast Discomfort/Pain

  MAUDE report 15382128 ↗
• InjuryJan 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A (LEFT) 375CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 360CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT SELF-DIAGNOSED A LEFT BREAST LUMP AND A RIGHT BREAST CYST. AS A RESULT, THE PATIENT UNDERWENT A SERIES OF EXAMINATIONS. ULTRASOUND FOUND MICROCALCIFICATIONS ON BOTH BREASTS, AND NODULES IN THE LEFT BREAST WHICH WERE REPORTED TO BE POSSIBLE SILICONE IN THE LEFT AXILLARY LYMPH NODES. THERE IS ALSO SUSPICION OF BILATERAL BREAST IMPLANT RUPTURES. THE PATIENT UNDERWENT EXCISION OF THE MASS FROM THE LEFT AXILLA. PATHOLOGY SHOWED PRESENCE OF SILICONE MATERIAL WITHIN THE AXILLARY LYMPH NODES BUT THERE IS NO EVIDENCE OF MALIGNANCY. THERE IS HOWEVER EVIDENCE OF ENLARGEMENT OF CHRONIC INFLAMMATORY REACTION OCCURRING IN THE AXILLARY AREA. THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST PTOSIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Calcium Deposits/Calcification; Capsular Contracture; Cyst(s)

  MAUDE report 13232465 ↗
• InjuryNov 16, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 550CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 360CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III/IV CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED THROUGH A PHYSICAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-12748 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 12824977 ↗
• InjuryAug 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 360CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE. MRI AND MAMMOGRAM PERFORMED ON (B)(6) 2021 INDICATED THE LEFT-SIDED RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Pain; Seroma

  MAUDE report 12350651 ↗
• InjuryAug 20, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 360CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8912147 ↗
• InjuryAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 360CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8912145 ↗
• InjuryJun 7, 2019Adverse 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 WHO UNDERWENT VERTICAL MASTOPEXY AND PRIMARY BREAST AUGMENTATION WITH TWO 360CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2018, HAD RECURRENT PROBLEMS WITH CELLULITIS OF THE LEFT BREAST WHICH APPARENTLY RESPONDED TO CIPRO AND KEFLEX ON TWO OCCASIONS. THE PATIENT HAD RECURRENT ERYTHEMA AND SWELLING OF THE LEFT BREAST THAT OCCURRED APPROXIMATELY (B)(6) 2019. THE PATIENT WAS AGAIN TREATED WITH CIPRO AND KEFLEX. A NEEDLE WAS STUCK INTO THE AREA OF MAXIMUM INDURATION AND THE RESULTS OF THIS ARE UNKNOWN. SINCE THAT TIME, THE PATIENT HAD FEVERS, SWELLING, PAIN AND ERYTHEMA, OF THE LEFT BREAST. THE PATIENT WAS SEEN IN THE ER WHERE SHE WAS NOTED TO BE STABLE BUT PRESENTED WITH A HOT, TENDER, PAINFUL AND SWOLLEN LEFT BREAST. THE PATIENT HAD A WBC OF 11,000. PER REPORTER, THE INFECTION WAS ALSO SPREADING TO THE PATIENT'S LEFT EYE. THERE WAS AN AREA THAT WAS BULGING ALONG THE VERTICAL LIMB ON THE LEFT SIDE WHICH IS WHERE THE SURGEON FELT WAS LIKELY AN ABSCESS THAT WAS ABOUT TO RUPTURE. THE PATIENT UNDERWENT REMOVAL OF THE LEFT INTACT BREAST IMPLANT AND INCISION AND DRAINAGE OF THE 100-150 ML OF A NON FOUL SMELLING YELLOW/BROWN FL

  Patient problems: Abscess; Necrosis; No Code Available; Unspecified Infection

  MAUDE report 8680799 ↗
• InjuryJun 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 360CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) /2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8672148 ↗
• InjuryJun 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 360CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8672145 ↗
• InjuryJan 25, 2019Material Discolored; Peeled/Delaminated; Material Discolored; Peeled/Delaminated

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 360CC. THE DEVICE WAS REPORTED AS ¿CLOUDY OR DELAMINATING¿ UPON VISUAL EXAMINATION BY THE PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 790CC, CATALOG NUMBER SHPX-790, SERIAL NUMBER (B)(4), LOT NUMBER 7629623 (L) AND MENTOR MEMORYGEL BREAST IMPLANT 450CC, CATALOG NUMBER 3504501BC, SERIAL NUMBER (B)(4), LOT NUMBER 7611062 (R) ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8279670 ↗