MENTOR MemoryGel Breast Implant 3542757MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00081317004387), received between Mar 14, 2018 and Nov 18, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Material Rupture” (19 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LOCAL REACTION AND 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: Local Reaction

  MAUDE report 23586791 ↗
• InjuryNov 14, 2025Material Discolored; Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Discolored; Material Rupture; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH AN UNKNOWN MENTOR SILICONE PROSTHESIS EXPERIENCES UNKNOWN SIDED SILENT SYMMETRY POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement; Seroma

  MAUDE report 23560401 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23077263 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED VIA MAMMOGRAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024. ON APRIL 18, 2024, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN IN ADDITION TO LEFT SIDE RUPTURE, AND UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507255MC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3507275MC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19168726 ↗
• InjuryMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED VIA MAMMOGRAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024. LEFT SERIAL NUMBER: (B)(6). RIGHT SERIAL NUMBER: (B)(6).

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19000641 ↗
• InjuryJan 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 275CC ON THE LEFT, AND 300CC ON THE RIGHT SIDE, SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN IMPLANTS ON AN UNSPECIFIED DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18427023 ↗
• InjuryNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18239722 ↗
• InjuryNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18238938 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16629824 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED ANISOMASTIA ON THE LEFT SIDE AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WERE CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16339243 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15420480 ↗
• InjuryMay 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14318736 ↗
• InjuryFeb 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE, AND WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT (DATE OF IMPLANT: (B)(6) 2014) AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY GRANULOMA FORMATION IN THE RIGHT AXILLA REGION CONFIRMED BY BIOPSY PERFORMED DURING SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE; BAKER GRADE II ON THE LEFT, AND BAKER GRADE III ON THE RIGHT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED LATE ONSET SEROMA, THE FLUID WAS SENT FOR PATHOLOGY, AT THIS TIME, THE RESULTS OF THE PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH BILATERAL NEW SALINE IMPLANTS ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Granuloma; Seroma

  MAUDE report 13472409 ↗
• InjuryFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13416000 ↗
• InjuryDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST IMPLANT RUPTURES, POST-PROCEDURE. THE RUPTURES WERE DIAGNOSED VIA AN ULTRASOUND EXAMINATION. AS A RESULT, THE PATIENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2021. THE REPLACEMENT DEVICES WERE: (LEFT) 190CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507190MC LOT: 9594306 SN: (B)(4) AND (RIGHT) 190CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507190MC LOT: 9594306 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12929317 ↗
• InjuryDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED BILATERAL BREAST IMPLANT RUPTURES, POST-PROCEDURE. THE RUPTURES WERE DIAGNOSED VIA AN ULTRASOUND EXAMINATION. AS A RESULT, THE PATIENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2021. THE REPLACEMENT DEVICES WERE: (LEFT) 190CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507190MC LOT: 9594306 SN: (B)(4) AND (RIGHT) 190CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507190MC LOT: 9594306 SN: 9594306-004. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12929054 ↗
• InjurySep 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12485756 ↗
• InjuryJul 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 275CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT (SERIAL NUMBER (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12130003 ↗
• InjuryApr 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED RIGHT BREAST SEROMA AND RIGHT BREAST IMPLANT RUPTURE, POST-PROCEDURE. THE PATIENT INITIALLY SELF DIAGNOSED THE CHANGES ON THE RIGHT BREAST AND EVENTUALLY WAS ELECTED TO HAVE AN ULTRASOUND WITH ASPIRATION ON (B)(6) 2021. 90CC OF FLUID WAS COLLECTED FROM THE RIGHT BREAST AND IT WAS TESTED FOR BIA-ALCL, WHICH CAME BACK NEGATIVE FOR CD30. IMAGING RESULTS SUSPECTED INTRACAPSULAR RUPTURE ON THE RIGHT IMPLANT. AS A RESULT, THE PATIENT WENT FOR REVISION SURGERY ON (B)(6) 2021. UPON REMOVAL OF THE RIGHT IMPLANT, IT WAS CONFIRMED TO HAVE A SMALL RUPTURE. SUBSEQUENTLY, THE PATIENT UNDERWENT BILATERAL REMOVAL, BILATERAL COMPLETE CAPSULECTOMIES AND BILATERAL REPLACEMENT WITH THE FOLLOWING DEVICES: (RIGHT) 240CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX240 LOT: 9532961 SN: (B)(4) AND (LEFT) 240CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX240 LOT: 9534058 SN: (B)(4).

  Patient problems: Seroma

  MAUDE report 11611520 ↗
• InjuryMar 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN VIA A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11506892 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 27CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11305498 ↗
• InjuryMay 13, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH MENTOR MEMORYGEL, 275CC SILICONE BREAST IMPLANTS WHICH THE PATIENT REPORTED THE FOLLOWING: HAVING FEWER, HAIR LOSS, HER IMPLANT HAS CHANGED SHAPE AND DISTORTED AND ITS MOVING AROUND JUST A LITTLE BIT AND SHE CAN NOTICED IT SOMETIMES WHEN SHE SLEEPS HER BRA ISN'T AS COMFORTABLE AS IT USED TO BE AND IT HURTS A LITTLE BIT, AND IT HAS GOTTEN LOWER THAN BEFORE. SHE INDICATED RED SCARRING, AND THAT ALL HER SYMPTOMS ARE HAPPENING ON THE LEFT SIDE WHERE SHE HAD CANCER. PATIENT ALSO INDICATED THAT SHE HAD DOUBLE MASTECTOMY, AND HAD RECONSTRUCTION DONE BECAUSE THE IMPLANTS DIDN¿T LOOK GOOD, SO THE SURGEON SWITCHED THE IMPLANT AND TRIED TO DROP THE IMPLANT LOWER, BUT IT WASN¿T LIKE THE ORIGINAL RECONSTRUCTION. THE ISSUE HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. 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.

  Patient problems: No Code Available; Wound Dehiscence; Wrinkling

  MAUDE report 10052131 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC AND EXPERIENCED BILATERAL BREAST PAIN AND SYMPTOMS INCLUDING JOINT PAIN, URINARY TRACT INFECTIONS, ANXIETY, BRAIN FOG, RASH, DECREASED VISION, FATIGUE, BODY PAIN, AND WEIGHT GAIN POST-OPERATIVELY. 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: No Code Available; Pain

  MAUDE report 9898244 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC AND EXPERIENCED BILATERAL BREAST PAIN AND SYMPTOMS INCLUDING JOINT PAIN, URINARY TRACT INFECTIONS, ANXIETY, BRAIN FOG, RASH, DECREASED VISION, FATIGUE, BODY PAIN, AND WEIGHT GAIN POST-OPERATIVELY. 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: No Code Available; Pain

  MAUDE report 9898241 ↗
• InjuryMar 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES. MRI CONFIRMED THAT THE LEFT BREAST PROSTHESIS HAD RUPTURED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7340153 ↗