MENTOR MemoryGel Breast Implant 3544007Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 00081317000716), received between Apr 10, 2018 and Sep 14, 2026 — classified as 166 injuries.

The most frequently reported specific device problem is “Material Rupture” (140 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 166 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 400cc 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 bilateral exchange with Mentor gel implants on (b)(6), 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759428 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM AND ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES AND ABNORMAL LYMPH NODES. 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: Swollen Lymph Nodes/Glands

  MAUDE report 23660326 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM AND ULTRASOUND, WITH BILATERAL BREAST IMPLANT RUPTURES AND ABNORMAL LYMPH NODES. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 23660324 ↗
• InjuryOct 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 400CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED RIGHT IMPLANT. MAGNETIC RESONANCE IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL HAVE BEEN 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 23314793 ↗
• InjuryAug 20, 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 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND A 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. THE PATIENT MENTIONED BREAST HARDENING AND DISCOMFORT WITH INTENSE PAIN ON THE LEFT SIDE. 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: Capsular Contracture

  MAUDE report 22852031 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22800713 ↗
• InjuryJul 24, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT AND DEVELOPED A SILICONE GRANULOMA WITH PAIN IN THE RIGHT AXILLA REGION MOST LIKELY CAUSED BY THE MICROSCOPIC DIFFUSION OF SILICONE GEL THROUGH THE SHELL OF THE RIGHT SILICONE BREAST IMPLANT (GEL BLEED). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Granuloma

  MAUDE report 22591894 ↗
• InjuryJun 30, 2025Use 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 59-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. SYMPTOMS OF BREAST SHAPE CHANGE WAS REPORTED ON BOTH SIDES. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. MENTOR IS AWARE OF THE DISCREPANCY BETWEEN THE DATE OF IMPLANT AND EXPIRATION DATE. MENTOR WILL FOLLOWED UP TO CLARIFY THIS INFORMATION. FOR THIS REASON, THE MEDICAL DEVICE PROBLEM CODE OF "USE OF DEVICE PROBLEM¿ (A23) HAS BEEN ADDED. IF ADDITIONAL INFORMATION IS RECEIVED CLARIFYING THE DATES DISCREPANCY, A SUPPLEMENTAL REPORT WILL BE SENT. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22366654 ↗
• InjuryJun 30, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ANISOMASTIA ON THE RIGHT SIDE POST-OPERATIVELY. SYMPTOMS OF BREAST SHAPE CHANGE WAS REPORTED ON BOTH SIDES. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. MENTOR IS AWARE OF THE DISCREPANCY BETWEEN THE DATE OF IMPLANT AND EXPIRATION DATE. MENTOR WILL FOLLOWED UP TO CLARIFY THIS INFORMATION. FOR THIS REASON, THE MEDICAL DEVICE PROBLEM CODE OF "USE OF DEVICE PROBLEM¿ (A23) HAS BEEN ADDED. IF ADDITIONAL INFORMATION IS RECEIVED CLARIFYING THE DATES DISCREPANCY, A SUPPLEMENTAL REPORT WILL BE SENT. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22364832 ↗
• InjuryApr 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A FALL. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21915120 ↗
• InjuryApr 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A FALL. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21915119 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND BILATERAL BREAST PAIN POSTOPERATIVELY. MRI CONFIRMED RUPTURE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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: Breast Discomfort/Pain

  MAUDE report 21515755 ↗
• InjuryFeb 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21415351 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A CT SCAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20508785 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400 CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A CT SCAN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20508614 ↗
• InjurySep 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 400CC AND EXPERIENCED BILATERAL RUPTURE ALONG WITH BILATERAL GRANULOMAS POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Granuloma

  MAUDE report 20157916 ↗
• InjurySep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA AN IN-OFFICE EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20131557 ↗
• InjuryJul 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 400CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. A 30 MINUTE DELAY WAS REPORTED, ALTHOUGH, NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DELAY. AN EVENT DATE PRIOR TO THE EXPLANTATION DATE WAS PROVIDED. FOLLOW-UPS WERE CONDUCTED. THE SURGEON INDICATED THERE WERE NO ACCOMPANYING SYMPTOMS PRIOR TO THE SURGERY AND DID NOT DISCLOSE A REASON FOR THE REPLACEMENT SURGERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19651739 ↗
• InjuryJul 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 400CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. A 30 MINUTE DELAY WAS REPORTED, ALTHOUGH, NO PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DELAY. AN EVENT DATE PRIOR TO THE EXPLANTATION DATE WAS PROVIDED. FOLLOW-UPS WERE CONDUCTED. THE SURGEON INDICATED THERE WERE NO ACCOMPANYING SYMPTOMS PRIOR TO THE SURGERY AND DID NOT DISCLOSE A REASON FOR THE REPLACEMENT SURGERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19651692 ↗
• InjuryJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED DURING A ROUTINE LDCT SCREENING. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19610532 ↗
• InjuryMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO UNSPECIFIED MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT RUPTURE ON ONE UNSPECIFIED BREAST AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN, ON THE OTHER BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19355738 ↗
• InjuryMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19290216 ↗
• InjuryMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS INITIALLY REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED A BURNING SENSATION IN HER RIGHT BREAST. IT WAS LATER REPORTED THAT MAMMOGRAM & ULTRASOUND RESULTS INDICATED THAT THE RIGHT BREAST PROSTHESIS WAS INTACT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED LEFT BREAST PROSTHESIS WAS RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2023-14300 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18991764 ↗
• InjuryMar 12, 2024Adverse 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 PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT BREAST PROSTHESIS POSSIBLY RUPTURED. LASTLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED BILATERAL WRINKLING ON THE BREASTS IN MAY 2002. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-02240 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 18888745 ↗
• InjuryFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT BREAST PROSTHESIS POSSIBLY RUPTURED. AS A RESULTS, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18764012 ↗