MENTOR MemoryGel Breast Implant 3507800MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317004301), received between Jul 24, 2019 and Oct 15, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 23302755 ↗
• InjuryAug 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, HAD A FALL AND SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 19932652 ↗
• InjuryAug 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, HAD A FALL AND SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 19932605 ↗
• InjuryDec 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 800CC AND EXPERIENCED 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. SEE MANUFACTURER REPORT NUMBER 1645337-2023-15219 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18414899 ↗
• InjuryDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 800CC AND EXPERIENCED 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. SEE MANUFACTURER REPORT NUMBER 1645337-2023-15218 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18404609 ↗
• InjuryOct 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PLACED EXPERIENCED A RUPTURE ON AN UNKNOWN SIDE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE SERIAL NUMBER IS EITHER (B)(6), OR (B)(6). THIS IS REFLECTED IN D4.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 17981211 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD WHITE FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE WOUND INFECTION POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16645227 ↗
• InjurySep 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION FOR REMOVAL AND REPLACEMENT WITH LIKE DEVICE ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10609639 ↗
• InjuryJul 12, 2020Migration; Migration

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS IS EXPERIENCING ISSUES WITH HER RIGHT BREAST PROSTHESIS MIGRATING. THE PATIENT REPORTED THAT HER RIGHT BREAST PROSTHESIS IS SLIPPING AND FOLDING IN HER CHEST AND IT IS CAUSING PAIN. SHE REPORTED THAT THE DEVICE FOLDS NO MATTER IF SHE IS LYING DOWN OR STANDING UP. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain; Wrinkling

  MAUDE report 10262108 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS NOTICED PRESSURE AND FIRMNESS ON THE TOP OF HER LEFT BREAST. THE PATIENT¿S LEFT BREAST IS BIGGER THAN HER RIGHT BREAST. PATIENT WAS LATER DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION AND REPLACEMENT WITH UNKNOWN BREAST PROSTHESES ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9578648 ↗
• InjuryJul 24, 2019Adverse 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 BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800 CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE, CONFIRMED BY PHYSICIAN. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2019.

  Patient problems: Capsular Contracture; Hematoma; No Code Available

  MAUDE report 8822463 ↗