MENTOR MemoryGel Breast Implant 3542257Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00081317000648), received between Feb 12, 2019 and Apr 23, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Material Rupture” (32 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24968706 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE AND A SMALL AMOUNT OF PERI IMPLANT FLUID ON BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606345 ↗
• InjuryMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED A RUPTURED RIGHT BREAST IMPLANT AND UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 235CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2025. THE INFORMATION DID NOT SPECIFY IF THE REVISION PROCEDURE WAS A RESULT OF THE RUPTURE OR THE RUPTURE WAS DISCOVERED DURING THE PROCEDURE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21636083 ↗
• InjurySep 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249482 ↗
• InjurySep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 225CC AND EXPERIENCED RUPTURE ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION WITH SAME VOLUME ENGRAVED ON THE PATCH. SINCE IT IS UNKNOWN WHICH DEVICE IS THE REPORTED IMPACTED PRODUCT, AND BOTH DEVICES WERE FOUND DAMAGED (NO INSTRUMENT DAMAGE) PER ANALYSIS FINDINGS, BOTH DEVICES WILL BE CONSERVATIVELY REPORTED FOR DEFLATION. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20126491 ↗
• InjuryJun 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 225 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND ASYMMETRY OF THE RIGHT BREAST. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING COMPUTERIZED TOMOGRAPHY 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.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 19607343 ↗
• InjuryMay 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 225CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. 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 19439307 ↗
• InjuryMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19372833 ↗
• InjuryFeb 2, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 225CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2023-15342. ON JANUARY 25, 2024 INVESTIGATION OF THE RETURNED DEVICE REVEALED POSSIBLE RUPTURE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18634738 ↗
• InjuryDec 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION, ULTRASOUND, AND MAMMOGRAM. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18421974 ↗
• InjuryNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 18235683 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 225CC 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 17958732 ↗
• InjuryOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST AS WELL AS A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WERE CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 17869653 ↗
• InjurySep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17684238 ↗
• InjurySep 1, 2023Migration; Migration

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED DEVICE MIGRATION AND BACK PAIN POST PROCEDURE. THE IMPLANT APPEARS TO HAVE FLIPPED CAUSING AN IRREGULAR CURVATURE IN HER CLEAVAGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 17674645 ↗
• InjuryJun 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED 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 17139643 ↗
• InjuryMar 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 225CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16659577 ↗
• InjuryAug 17, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED AUTOIMMUNE-LIKE SYMPTOMS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A BREAST MASS/LUMP AND THAT THERE WAS BILATERAL RUPTURE OF THE BREAST PROSTHESES POST IMPLANTATION. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15243249 ↗
• InjuryAug 17, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED AUTOIMMUNE-LIKE SYMPTOMS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A BREAST MASS/LUMP AND THAT THERE WAS BILATERAL RUPTURE OF THE BREAST PROSTHESES POST IMPLANTATION. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15243243 ↗
• InjuryMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE PAIN AND BREAST IMPLANT RUPTURE POSTOPERATIVELY. IT WAS REPORTED THAT THE PATIENT HAD A FALL. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6), 2022.

  Patient problems: Breast Discomfort/Pain; Crushing Injury

  MAUDE report 13685805 ↗
• InjuryFeb 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD A PHYSICAL EXAM AND MAMMOGRAM IMAGING PERFORMED. THEIR HEALTH PROFESSIONAL STATED THAT THE PATIENTS LEFT BREAST IMPLANT FELT AMORPHOUS AND IT WAS DIFFICULT TO FEEL THE EDGES OF THE IMPLANT. AS SUCH, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13473621 ↗
• InjuryAug 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12334741 ↗
• InjuryAug 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12334740 ↗
• InjuryJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST, SUFFERED LEFT BREAST IMPLANT RUPTURE, SHAPE CHANGE, AND INTERMITTENT HARDENING, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12094434 ↗
• InjuryNov 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING REPLACEMENT SURGERY. BILATERAL REPLACEMENT WITH 240CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED WITH EXPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10888937 ↗