MENTOR MemoryGel Breast Implant 3541751Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317000815), received between Sep 10, 2019 and Nov 14, 2025 — classified as 18 injuries.

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.

• InjuryNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL RUPTURE 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23557660 ↗
• InjuryNov 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL RUPTURE 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23557656 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3503004BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502504BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21536672 ↗
• InjuryDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATENT UNDERWENT BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18314774 ↗
• InjuryApr 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. IT WAS REPORTED THAT THE GEL BLEED IS WORSE ON THE RIGHT SIDE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE DIAGNOSIS WAS CONFIRMED DURING BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507190MC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3507235MC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16664893 ↗
• InjuryApr 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY. IT WAS REPORTED THAT THE GEL BLEED IS WORSE ON THE RIGHT SIDE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE DIAGNOSIS WAS CONFIRMED DURING BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507190MC; SERIAL NUMBER :(B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3507235MC; SERIAL NUMBER: (B)(4) ON THE RIGHT SIDE ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16664891 ↗
• InjuryNov 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, REMOVAL WITHOUT REPLACEMENT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15839167 ↗
• InjuryFeb 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH A MENTOR MEMORYGEL, 350CC ON THE LEFT SIDE, AND 175CC O THE RIGHT SIDE, SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED RUPTURE, HEADACHES, JOINT PAIN, BREAST PAIN, HAIR LOSS, HORMONE IMBALANCE, AND BRAIN FOG. THE MAMMOGRAMS AND ULTRASOUND EXAMINATIONS WERE NEGATIVE. THE PATIENT STATED THAT RADIOLOGIST STATED LEAKAGE (RIGHT AXILLARY LINDEN) PRESENT IN THE ULTRASOUND. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

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

  MAUDE report 13587994 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 125CC MENTOR MEMORYGEL LEFT BREAST IMPLANT AND A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO UNSPECIFIED MEMORY GEL XTRA BREAST IMPLANTS ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11098979 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A REVISION BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 225CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. ON (B)(6) 2020, ULTRASOUND WAS PERFORMED, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2020. AFTER THE REVISION SURGERY, THE PATIENT HAS FULLY RECOVERED. THE DATE OF IMPLANTATION WAS ESTIMATED AS (B)(6) 2013 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11084709 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A REVISION BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 225CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. ON (B)(6) 2020, ULTRASOUND WAS PERFORMED, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2020. AFTER THE REVISION SURGERY, THE PATIENT HAS FULLY RECOVERED. THE DATE OF IMPLANTATION WAS ESTIMATED AS (B)(6) 2013 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11066773 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS ON AN UNKNOWN DATE EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2020. SEE 1645337-2020-16017 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 11024491 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS ON AN UNKNOWN DATE EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2020. SEE 1645337-2020-16018 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 11024488 ↗
• InjurySep 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10518359 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE III) IN BOTH BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE 2ND OF TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9114193 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE III) IN BOTH BREASTS. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE 1ST OF TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9114192 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN-AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Wrinkling

  MAUDE report 8984771 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN-AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Wrinkling

  MAUDE report 8984770 ↗