MENTOR MemoryGel Breast Implant 3543757Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00081317000709), received between Apr 3, 2018 and Apr 21, 2026 — classified as 114 injuries.

The most frequently reported specific device problem is “Material Rupture” (100 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 114 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS AND HER LEFT BREAST IMPLANT MOVED UP AND IT IS HARD. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24946638 ↗
• 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 LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22852028 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22439052 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22439048 ↗
• InjuryFeb 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE BAKER GRADE 2 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21346237 ↗
• InjuryJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SMHX500).

  Patient problems: Capsular Contracture

  MAUDE report 21278562 ↗
• InjuryJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE DIAGNOSIS WAS MADE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21104201 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED ¿IMPLANT BREAKING DOWN¿ AND KNOT IN THE BREAST WITH RIPPLING POST-OPERATIVELY. IT WAS REPORTED THAT THE MRI AND ULTRASOUND SHOW NO CONFIRMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT PROVIDED NO SPECIFIC AND VERY LIMITED INFORMATION. THE PATIENT ALSO DID NOT WANT TO OPEN A CLAIM AND REMOVED TO PROVIDE ANY ADDITIONAL INFORMATION. IF MENTOR RECEIVES ANY ADDITIONAL INFORMATION REGARDING THE EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 20845116 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375 CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED ¿IMPLANT BREAKING DOWN¿ AND KNOT IN THE BREAST WITH RIPPLING POST-OPERATIVELY. IT WAS REPORTED THAT THE MRI AND ULTRASOUND SHOW NO CONFIRMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT PROVIDED NO SPECIFIC AND VERY LIMITED INFORMATION. THE PATIENT ALSO DID NOT WANT TO OPEN A CLAIM AND REMOVED TO PROVIDE ANY ADDITIONAL INFORMATION. IF MENTOR RECEIVES ANY ADDITIONAL INFORMATION REGARDING THE EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 20844916 ↗
• InjuryJun 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL, 375CC, SILICONE EXPERIENCED RIGHT-SIDED SKIN REACTION, GRANULOMA, AND SYMPTOMATIC RUPTURE POSTOPERATIVE. PATIENTS RIGHT SIDE A LITTLE SMALLER, ITCHES, CT SCAN SHOWED A LUMP ON PATIENT RIGHT LUNG, SKIN BREAKS OUT ALL THE TIME, MAY HAVE SILICONE UNDER HER ARMS ON THE RIGHT SIDE, AND WAS CONFIRMED BY ULTRASOUND EXAMINATION. THE PATIENT EXPLAINED THAT SHE HAS SKIN BREAKOUTS UNDER HER RIGHT BREAST AND AROUND HER RIGHT UNDERARM. SHE SAYS SHE FEELS THIS ITCHINESS FROM THE INSIDE ON HER RIGHT BREAST AND THAT HER RIGHT BREAST WEIGHS LESS AND LOOKS SMALLER. THE PATIENT ALSO CONFIRMED PREVIOUS REPORT OF SILICONE LYMPHADENOPATHY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Granuloma; Skin Inflammation/ Irritation; Swollen Lymph Nodes/Glands

  MAUDE report 19493109 ↗
• InjuryNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 375CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURE, BREAST PAIN, AND PARESTHESIA POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia

  MAUDE report 18121640 ↗
• InjuryNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 375CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SYMPTOMATIC RUPTURE, BREAST PAIN, AND PARESTHESIA POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia

  MAUDE report 18121578 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED AUTOIMMUNE AND GENERALIZED ILLNESS LIKE SYMPTOMS, BILATERAL BREAST PAIN, RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV), FIRMNESS, SEROMA AND IMPLANT LEAKAGE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18007785 ↗
• InjuryOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED AUTOIMMUNE AND GENERALIZED ILLNESS LIKE SYMPTOMS, BILATERAL BREAST PAIN, RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV), FIRMNESS, SEROMA AND IMPLANT LEAKAGE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture

  MAUDE report 18007782 ↗
• InjuryOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 375CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVE. THE ISSUE WAS DIAGNOSED BY HEALTH CARE PROFESSIONAL AND CONFIRMED BY THE MAMMOGRAM EXAMINATIONS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNKNOWN PROSTHESIS ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17878193 ↗
• InjuryOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 375CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURES POSTOPERATIVE. THE ISSUE WAS DIAGNOSED BY HEALTH CARE PROFESSIONAL AND CONFIRMED BY THE MAMMOGRAM EXAMINATIONS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNKNOWN PROSTHESIS ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17878107 ↗
• InjuryAug 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17647025 ↗
• InjuryAug 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2023. THE DATE OF IMPLANTATION AND EVENT WERE NOTE PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17494036 ↗
• InjuryJul 12, 2023Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 375CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND BILATERAL GEL BLEED POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMIES, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SMPB265, SERIAL NUMBER (B)(6) , RIGHT CATALOG NUMBER SMPB265, SERIAL NUMBER (B)(6) ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17307925 ↗
• InjuryJul 12, 2023Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 375CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SYMPTOMATIC RUPTURES AND BILATERAL GEL BLEED POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMIES, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SMPB265, SERIAL NUMBER (B)(6), RIGHT CATALOG NUMBER SMPB265, SERIAL NUMBER (B)(6) ON (B)(6), 2023. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17307868 ↗
• InjuryJun 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS SMOOTH ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND GENERALIZED ILLNESS SYMPTOMS INCLUDING FATIGUE, SICK, COLD INTOLERANCE, BREATHING PROBLEM, AND ABNORMAL SENSATIONS POSTOPERATIVELY. MAMMOGRAM WAS TAKEN. THE PATIENT HAS CONSULTED WITH THE MEDICAL 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 RIGHT-SIDED DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17155083 ↗
• InjuryJun 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS SMOOTH ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND GENERALIZED ILLNESS SYMPTOMS INCLUDING FATIGUE, SICK, COLD INTOLERANCE, BREATHING PROBLEM, AND ABNORMAL SENSATIONS POSTOPERATIVELY. MAMMOGRAM WAS TAKEN. THE PATIENT HAS CONSULTED WITH THE MEDICAL 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17155070 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF BOTH PROSTHESES, WHICH WAS CONFIRMED VIA MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02470 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16482128 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF BOTH PROSTHESES, WHICH WAS CONFIRMED VIA MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6), 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02469 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16482104 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY, WHICH WAS DIAGNOSED IN PERSON AND MRI. THE PATIENT HAD INDENTATION OF BILATERAL LOWER POLE. IT WAS ALSO REPORTED THAT THE PATIENT ALSO EXPERIENCED A RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 16461494 ↗