MENTOR MemoryGel Breast Implant 3545320Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317007111), received between Jan 31, 2022 and Dec 12, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 37-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED "FLUID IN THE DEVICE" 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: Breast Discomfort/Pain; Impaired Healing; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794185 ↗
• InjuryAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING COMPUTERIZED TOMOGRAPHY IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 22853571 ↗
• InjuryJul 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 320C MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE, BREAST PAIN, AND A SEROMA ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT VIA SURGICAL WASHING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Seroma

  MAUDE report 22460155 ↗
• InjuryMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 320CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21690047 ↗
• InjuryFeb 19, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE, RIGHT GRANULOMA, BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, AND LEFT SIDED GEL BLEED POST PROCEDURE. THESE FINDINGS WERE DEMONSTRATED THROUGH MAGNETIC RESONANCE IMAGING AND ULTRASOUND. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. THE RIGHT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2024-14384. ON (B)(6) 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21410093 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 20893336 ↗
• MalfunctionSep 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 320CC MENTOR MEMORYGEL BREAST IMPLANT WAS FOUND TO BE RUPTURED DURING AN OPERATION. 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 20334685 ↗
• InjurySep 5, 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 PRIMARY WITH AMENTOR MEMORYGEL, 320CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH MRI EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6), 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20149956 ↗
• InjuryFeb 20, 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 REVISION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL LATE ONSET SEROMA POST PROCEDURE. AS A RESULT, REPLACEMENT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2024-02032 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Seroma

  MAUDE report 18744775 ↗
• InjuryFeb 20, 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 REVISION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL LATE ONSET SEROMA POST PROCEDURE. AS A RESULT, REPLACEMENT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2024-02033 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Seroma

  MAUDE report 18744773 ↗
• InjuryJun 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED BY 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: Deformity/ Disfigurement

  MAUDE report 17219496 ↗
• MalfunctionOct 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 320CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED DURING A PRIMARY BREAST AUGMENTATION. THERE WERE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556652 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. 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-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 13619724 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. 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 13619716 ↗
• InjuryJan 31, 2022Adverse 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 A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE IV IN LEFT BREAST, BAKER GRADE III IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13401621 ↗