MENTOR MemoryGel Breast Implant 3508001BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00081317000389), received between Apr 5, 2018 and Sep 11, 2026 — classified as 165 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (95 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 167 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed via mammogram. As a result, the patient is scheduled for removal on (b)(6), 2026.This report is for the right breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735831 ↗
• InjurySep 10, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715690 ↗
• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL SUSPECTED RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. UPON EXPLANTATION, THE LEFT BREAST PROSTHESIS WAS FOUND TO BE INTACT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25203679 ↗
• InjuryMay 1, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25059764 ↗
• InjuryApr 24, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24990746 ↗
• InjuryMar 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24631492 ↗
• InjuryMar 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24631327 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED PAIN, KNOTS, AND SWELLING IN HER RIGHT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 24497861 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24369934 ↗
• InjuryNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT, LEFT BREAST CAPSULAR CONTRACTURE (A BAKER GRADE RATING WAS NOT PROVIDED), AND LEFT BREAST ANIMATION DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23525899 ↗
• InjuryNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT AND DURING SURGERY. THE PATIENT MENTIONED SHE HAD FALLEN AT WORK. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 23504021 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT 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 23337629 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800C MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WERE NOTICED FOLLOWING A CAR ACCIDENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23303142 ↗
• InjuryJul 21, 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 PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A REDUCTION IN BREAST VOLUME WITH FIRM AND HARD BREASTS. ULTRASOUND, MAMMOGRAM, AND MAGNETIC RESONANCE IMAGING WAS PERFORMED; HOWEVER A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS NOT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22561058 ↗
• InjuryJun 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RUPTURED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM AND USING MAMMOGRAM AND ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22180702 ↗
• InjuryApr 21, 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 PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS WAS DISSATISFIED WITH THE OUTCOME OF THE PROCEDURE. IT WAS REPORTED THAT THE WRONG PROFILE IMPLANT WAS USED. PATIENT WAS IMPLANTED WITH A MODERATE PROFILE 800CC IMPLANT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC HIGH PROFILE GEL IMPLANT IN (B)(6) 2019.

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

  MAUDE report 21874495 ↗
• InjuryMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DRAINAGE/DISCHARGE FROM THE INCISIONAL SITES OF BOTH BREASTS. DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL, THE FLUID OF THE RIGHT BREAST WAS DESCRIBED AS GELATINOUS DRAINAGE WHILE THE LEFT WAS A CLEAR LIQUID. THE RIGHT FLUID WAS DETERMINED TO BE SEROUS FLUID. AS A RESULT, THE PATIENT UNDERWENT REVISION OF THE BILATERAL BREASTS FOR EVALUATION ON (B)(6) 2025. DURING THE EXPLORATORY SURGERY, THE PATIENT WAS DISCOVERED TO HAVE A RUPTURED RIGHT BREAST IMPLANT WITH SEEPING SILICONE AND NO PROBLEMS WERE OBSERVED WITH THE LEFT IMPLANT. AS A RESULT, THE RIGHT BREAST IMPLANT WAS REPLACED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT WITHOUT REPLACEMENT OF THE LEFT. WOUND CULTURES WERE TAKEN FROM BOTH BREASTS TO RULE OUT ANY IMPENDING INFECTIONS. CULTURE RESULTS INDICATED THERE WAS BACTERIAL GROWTH OF THE LEFT SAMPLE WITHOUT GROWTH FROM THE RIGHT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Impaired Healing; Seroma

  MAUDE report 21657651 ↗
• InjuryMar 20, 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 AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DRAINAGE/DISCHARGE FROM THE INCISIONAL SITES OF BOTH BREASTS. DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL, THE FLUID OF THE RIGHT BREAST WAS DESCRIBED AS GELATINOUS DRAINAGE WHILE THE LEFT WAS A CLEAR LIQUID. THE RIGHT FLUID WAS DETERMINED TO BE SEROUS FLUID. AS A RESULT, THE PATIENT UNDERWENT REVISION OF THE BILATERAL BREASTS FOR EVALUATION ON (B)(6) 2025. DURING THE EXPLORATORY SURGERY, THE PATIENT WAS DISCOVERED TO HAVE A RUPTURED RIGHT BREAST IMPLANT WITH SEEPING SILICONE AND NO PROBLEMS WERE OBSERVED WITH THE LEFT IMPLANT. AS A RESULT, THE RIGHT BREAST IMPLANT WAS REPLACED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT WITHOUT REPLACEMENT OF THE LEFT. WOUND CULTURES WERE TAKEN FROM BOTH BREASTS TO RULE OUT ANY IMPENDING INFECTIONS. CULTURE RESULTS INDICATED THERE WAS BACTERIAL GROWTH OF THE LEFT SAMPLE WITHOUT GROWTH FROM THE RIGHT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21657648 ↗
• InjuryMar 14, 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 PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH AN 800 CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY PAIN AND THE DEVICE SITTING HIGH. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21608410 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED HAVING SEVERE PAIN AND DISCOMFORT ON THE LOWER LEFT SIDE OF THE BREAST AND AROUND THE BREAST. THE PATIENT HAS NOT BEEN ABLE TO WEAR WIRE OR SPORT'S BRA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21527048 ↗
• InjuryFeb 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND LOCAL REACTION SINCE PAIN AND SWELLING WAS REPORTED POSTOPERATIVELY. RUPTURE WAS CONFIRMED VIA ULTRASOUND. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.

  Patient problems: Local Reaction

  MAUDE report 21306540 ↗
• InjuryDec 3, 2024Adverse 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 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20839655 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM, AND MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024 THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20723165 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM, AND MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20723065 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20669662 ↗