MENTOR MemoryGel Breast Implant 3545590Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317007197), received between Feb 28, 2020 and Feb 25, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT RUPTURE ON THE LEFT SIDE CONFIRMED BY MRI AND COMPLICATED BY PAIN AND SILICONE MIGRATION TO THE LEFT AXILLARY REGION. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE IN THE LEFT BREAST. ADDITIONALLY, PERI IMPLANT FLUID REPORTED FOR BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442186 ↗
• InjuryDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873836 ↗
• InjuryDec 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23843291 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE ALONG WITH BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22309623 ↗
• InjuryMar 4, 2025Adverse 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 REVISION SURGERY WITH IMPLANTATION OF A 590 CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE 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 21518376 ↗
• InjuryJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19516091 ↗
• InjuryJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 590CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND LEFT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE IV. AS A RESULT, BILATERAL BREAST IMPLANT REMOVAL WITH EN BLOC CAPSULECTOMY WAS PERFORMED ON (B)(6) 2023. THE PATIENT¿S CONDITION IS IMPROVED. SEE 1645337-2023-06810 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 17083891 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 590CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND LEFT SIDED RUPTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE IV. AS A RESULT, BILATERAL BREAST IMPLANT REMOVAL WITH EN BLOC CAPSULECTOMY WAS PERFORMED ON (B)(6) 2023. THE PATIENT¿S CONDITION IS IMPROVED. SEE 1645337-2023-06809 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17083887 ↗
• InjuryMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 590CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-06417 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17035081 ↗
• InjuryMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 590CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-06418 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17035080 ↗
• InjuryMar 6, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III/IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED PERI-IMPLANT FLUID IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2023. PATHOLOGY AND CYTOLOGY REPORTS WERE REQUESTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 16492097 ↗
• InjurySep 12, 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 REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 590CC AND EXPERIENCED SUSPECTED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. DURING EXPLANTATION ON (B)(6) 2022, BOTH DEVICES WERE FOUND TO BE INTACT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15403053 ↗
• InjuryMar 4, 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 REVISION BREAST AUGMENTATION WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT-SIDED LOCAL REACTION AND IMPAIRED HEALING POSTOPERATIVELY. THE PATIENT HAS BEEN UNSATISFIED WITH THE BREAST AUGMENTATION OUTCOME. THE PATIENT STATES THAT HER LEFT BREAST IS LARGER THAN HER RIGHT BREAST, AND SHE DEVELOPED A FISTULA IN HER LEFT BREAST THREE MONTHS AFTER THE IMPLANTATION SURGERY. EVEN AFTER THE SWELLING WENT AWAY, HER LEFT BREAST REMAINS LARGER THAN HER RIGHT BREAST. 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.

  Patient problems: Impaired Healing; Local Reaction

  MAUDE report 11418007 ↗
• InjuryMay 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 590CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS. IN ADDITION, AN MRI CONFIRMED RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED SALINE BREAST PROSTHESES ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 10094543 ↗
• InjuryMay 27, 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 PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 590CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS. IN ADDITION, AN MRI CONFIRMED RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED SALINE BREAST PROSTHESES ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 10094542 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED UNSPECIFIED COMPLICATIONS, DIFFICULTY, AND RIGHT BREAST CAPSULAR CONTRACTURE; BAKER GRADE II, POST-OPERATIVELY. 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: Capsular Contracture; No Code Available

  MAUDE report 9770742 ↗
• InjuryFeb 28, 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 AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED UNSPECIFIED COMPLICATIONS, DIFFICULTY, AND RIGHT BREAST CAPSULAR CONTRACTURE; BAKER GRADE II, POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9770731 ↗