MENTOR MemoryGel Breast Implant 3545001Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00081317000921), received between May 9, 2019 and Jul 27, 2026 — classified as 66 injuries.

The most frequently reported specific device problem is “Material Rupture” (36 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A female patient who underwent Breast Augmentation Primary with a MENTOR MemoryGel , 500cc Silicone Breast implant experienced bilateral capsular contractures unknown grade post operation. The issue was diagnosed through physical examination. As a result, the patient scheduled for bilateral removal surgery on (b)(6) 2026. This report relates to the right side.

  Patient problems: Capsular Contracture

  MAUDE report 50039435 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A female patient who underwent Breast Augmentation Primary with a MENTOR MemoryGel , 500cc Silicone Breast implant experienced bilateral capsular contractures unknown grade post operation. The issue was diagnosed through physical examination. As a result, the patient scheduled for bilateral removal surgery on (b)(6) 2026. This report relates to the left side.

  Patient problems: Capsular Contracture

  MAUDE report 50039226 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND A RUPTURE 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 25303589 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND A RUPTURE 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 25303453 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23761035 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23753744 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2) ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2005, AND REPLACED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3505501BC) WITH SERIAL NUMBER (B)(6) (LEFT) AND (B)(6) (RIGHT). THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21923227 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2) ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2005 AND REPLACED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3505501BC) WITH SERIAL NUMBER (B)(6) (LEFT) AND (B)(6) (RIGHT). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21923226 ↗
• InjurySep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL REPORT, THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH SX MPP GEL 500CC MENTOR GEL BREAST IMPLANTS ON BOTH SIDES ON (B)(6) 2006. THE PATIENT EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, BILATERAL SWOLLEN LYMPH NODES, AND LEFT SIDE IMPLANT SITE FLUID COLLECTION. BREAST CANCER WAS OBSERVED ON OR ABOUT (B)(6) 2024 FROM CYTOLOGY FINDINGS ¿ ¿LEFT BREAST PERI-IMPLANT, CYTOLOGY WITH CELL BLOCK: MONOCLONAL CDL0 POSITIVE B CELL POPULATION AS PER FLOW CYTOMETRIC ANALYSIS¿. PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement; Swollen Lymph Nodes/Glands

  MAUDE report 20203781 ↗
• InjurySep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL REPORT, THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH SX MPP GEL 500CC MENTOR GEL BREAST IMPLANTS ON BOTH SIDES ON (B)(6) 2006. THE PATIENT EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, BILATERAL SWOLLEN LYMPH NODES, AND LEFT SIDE IMPLANT SITE FLUID COLLECTION. BREAST CANCER WAS OBSERVED ON OR ABOUT (B)(6) 2024 FROM CYTOLOGY FINDINGS ¿ ¿LEFT BREAST PERI-IMPLANT, CYTOLOGY WITH CELL BLOCK: MONOCLONAL CDL0 POSITIVE B CELL POPULATION AS PER FLOW CYTOMETRIC ANALYSIS¿. PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Breast Cancer; No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 20203204 ↗
• InjurySep 4, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED A DEVICE MIGRATION AND BREAST CYST ON THE LEFT SIDE AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s)

  MAUDE report 20140257 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED A DEVICE MIGRATION AND BREAST CYST ON THE LEFT SIDE AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20140104 ↗
• InjuryJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE CONFIRMED DURING EXPLANT. EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6), 2024. SEE 1645337-2024-01091 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18610941 ↗
• InjuryJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE CONFIRMED DURING EXPLANT. EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024. SEE 1645337-2024-01092 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18610938 ↗
• InjuryJan 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. MASTOPEXY AND EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2024-00225 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18452087 ↗
• InjuryJan 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. MASTOPEXY AND EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2024-00226 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18450110 ↗
• InjuryDec 14, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC EXPERIENCED A RUPTURE AND A LOCAL REACTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Local Reaction

  MAUDE report 18325996 ↗
• InjuryDec 14, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18325802 ↗
• InjuryDec 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY RECONSTRUCTION SURGERY WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE OF AN UNSPECIFIED BAKER GRADE AND A RUPTURE OF HER LEFT PROSTHESIS, WHICH WERE IDENTIFIED USING THE PATIENT¿S SYMPTOMS AND CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14519 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 18297478 ↗
• InjuryNov 22, 2023Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (R) AND MENTOR MEMORYGEL BREAST IMPLANT 500CC (L) AND EXPERIENCED GEL BLEED ON THE RIGHT SIDE AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-12497 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18194412 ↗
• InjuryOct 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 500CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17986622 ↗
• InjurySep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, MAMMOGRAM, AND ULTRASOUND, WITH SPONTANEOUS RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17726825 ↗
• InjuryAug 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON BOTH SIDES POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 17540016 ↗
• InjuryAug 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON BOTH SIDES POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 17540013 ↗
• InjuryJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17172395 ↗