MENTOR MemoryGel Breast Implant 3543207MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317004400), received between Sep 10, 2020 and May 7, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Appropriate Device Problem Term/Code Not Available

  A 320CC MENTOR MEMORYGEL BREAST IMPLANT WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 25118992 ↗
• InjuryApr 1, 2026Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 320 CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 300 CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24756960 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23899506 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. MRI SCAN WAS TAKEN. ON (B)(6) 2025, MENTOR BECAME AWARE THAT THE PATIENT ALSO SUFFERED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III/IV IN ADDITION TO LEFT SIDE RUPTURE AND DEVICES WERE EXPLANTED ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE LEFT SIDE REPLACEMENT DEVICE USED WAS CATALOG NUMBER SMPB450, SERIAL NUMBER (B)(6). THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23619204 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE 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: Capsular Contracture

  MAUDE report 22138390 ↗
• InjuryMar 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. MRI SCAN WAS TAKEN. 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 21532750 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 320CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY. MAMMOGRAM CONFIRMED RUPTURE. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507300MC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND CATALOG NUMBER 3507300MC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE ON (B)(6) 2025. ON (B)(6) 2025, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED RIGHT SIDE IMPLANT SITE CALCIFICATION IN ADDITION TO LEFT SIDE RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 21295719 ↗
• InjuryJul 2, 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 WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 320CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19659234 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. THE PATIENT HAD PUCKERING IN THE IMPLANTS AND PAIN. 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 18664320 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. THE PATIENT HAD PUCKERING IN THE IMPLANTS AND PAIN. 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 18664309 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 320CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT LEFT SIDED CAPSULECTOMY AND CAPSULOTOMY, AND UNILATERAL REPLACEMENT WITH LEFT CATALOG NUMBER 3507320MC, SERIAL NUMBER (B)(4) ON (B)(6) 2019. PLEASE SEE CURRENT EVENT IN MANUFACTURER REPORT NUMBER: 1645337-2023-02912.

  Patient problems: Capsular Contracture

  MAUDE report 16649669 ↗
• InjuryMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT BOTH OF THE PATIENT¿S BREAST PROSTHESES RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16584549 ↗
• InjuryMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 320CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT BOTH OF THE PATIENT¿S BREAST PROSTHESES RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16584548 ↗
• InjuryJun 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14569465 ↗
• InjuryJun 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 14569462 ↗
• InjurySep 13, 2021Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 320CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND LEFT-SIDED IMPLANT RUPTURE POSTOPERATIVELY. THE PATIENT REPORTED DISCOMFORT NEAR THE LEFT UNDERARM, AND RUPTURE WAS CONFIRMED BY MAMMOGRAM AND ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12461281 ↗
• InjuryOct 14, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED THE FOLLOWING: ON (B)(6) 2020 MAMMOGRAM FOUND INFLAMED LYMPH NODE IN THE PATIENT'S RIGHT ARMPIT, ON (B)(6) 2020 THE PATIENT HAD AN ULTRASOUND, ON (B)(6) 2020 THE PATIENT HAD NEED BIOPSY AND WHITING THICK LIQUID ATYPICAL CELLS KILLED OFF LYMPH NODE, ON (B)(6) 2020, THE LYMPH NODE WAS REMOVED SURGICALLY AND FINALLY ON (B)(6) 2020, A FOLLOW UP BIOPSY DISCOVERED THAT THERE WAS SILICONE IN THE LYMPH NODE. THE PATIENT WAS SCHEDULED FOR MRI ON (B)(6) 2020. THE PATIENT ALSO SUFFERED RIGHT BREAST IMPLANT RUPTURE, BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND LEFT IMPLANT FOLDING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT EXPLANTATION SURGERY ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10681009 ↗
• InjurySep 10, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 320CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED THE FOLLOWING: ON (B)(6) 2020 MAMMOGRAM FOUND INFLAMED LYMPH NODE IN THE PATIENT'S RIGHT ARMPIT, ON (B)(6) 2020 THE PATIENT HAD AN ULTRASOUND, ON (B)(6) 2020 THE PATIENT HAD NEED BIOPSY AND WHITING THICK LIQUID ATYPICAL CELLS KILLED OFF LYMPH NODE, ON (B)(6) 2020, THE LYMPH NODE WAS REMOVED SURGICALLY AND FINALLY ON (B)(6) 2020, A FOLLOW UP BIOPSY DISCOVERED THAT THERE WAS SILICONE IN THE LYMPH NODE. THE PATIENT WAS SCHEDULED FOR MRI ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Granuloma; No Code Available

  MAUDE report 10518348 ↗