MENTOR MemoryGel Breast Implant 3544600Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00081317001133), received between Nov 14, 2018 and May 22, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Material Rupture” (35 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING WEIGHT LOSS, HAIR LOSS, THYROID ISSUES, SICKNESS, AND GRANULOMA ON THE RIGHT SIDE. PER THE INFORMATION PROVIDED, "THE GEL IS ON THE RIGHT AND HAS CREATED 2 NODULES GOING UP TO THE RIGHT SIDE OF HER HEAD". NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Granuloma

  MAUDE report 25256871 ↗
• InjuryJan 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH POSSIBLY RUPTURED IMPLANTS (BILATERAL) USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24028975 ↗
• InjuryJan 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH POSSIBLY RUPTURED IMPLANTS (BILATERAL) USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24028973 ↗
• InjuryDec 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23840415 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. RIGHT SERIAL NUMBER: (B)(6). LEFT SERIAL NUMBER: (B)(6). FOLLOW-UPS ARE IN PROGRESS FOR SIDE CONFIRMATION. IF/WHEN THE INFORMATION IS RECEIVED, SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23378398 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SWOLLEN LYMPH NODES AND IMPLANT SITE FLUID COLLECTION ON THE LEFT SIDE, AND BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT THE LEFT SIDE VIA DRAINAGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 23076634 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SWOLLEN LYMPH NODES AND IMPLANT SITE FLUID COLLECTION ON THE LEFT SIDE, AND BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT THE LEFT SIDE VIA DRAINAGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 23076626 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED RUPTURE, RIGHT SIDED CAPSULAR CONTRACTURE, BILATERAL BREAST DISCOMFORT, BILATERAL PTOSIS, AND BILATERAL IMPLANT SITE FLUID POST PROCEDURE. THE RUPTURE WAS DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. A SMALL AMOUNT OF YELLOWISH FLUID WAS FOUND DURING EXPLANT. AS A RESULT, EXCHANGE WAS PERFORMED ON (B)(6) 2025. THE RIGHT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2025-06728. ON AUGUST 25, 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 23052887 ↗
• InjurySep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23041368 ↗
• InjuryJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXCHANGE WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22284228 ↗
• InjuryMar 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT¿S LEFT BREAST ¿DOUBLED IN SIZE¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 21682083 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. 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 21105182 ↗
• InjurySep 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 600CC AND EXPERIENCED RUPTURE ALONG WITH SWELLING ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Local Reaction

  MAUDE report 20213400 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL 600CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SKIN REACTION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19262145 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL 600CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SKIN REACTION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19262048 ↗
• InjuryOct 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A LEFT-SIDED 550CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 600CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE II CAPSULAR CONTRACTURE OF THE LEFT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12505 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17986866 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, INVOLVED IN A CLINICAL TRIAL, UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST MASSES/CYSTS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE THE MASSES/CYSTS. THERE WERE NO REPORTED MANIPULATIONS TO THE BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-00616 FOR THE CONTRALATERAL EVENT.

  Patient problems: Cyst(s)

  MAUDE report 17799528 ↗
• InjurySep 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS SEEN FOR A REVISION SURGERY. DURING THE REVISION, IT WAS DISCOVERED THAT THE PATIENT¿S LEFT PROSTHESIS WAS RUPTURED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED NON-MENTOR BREAST IMPLANT ON (B)(6) 2023. THERE WERE NO ADDITIONAL PATIENT CONSEQUENCES OR PROCEDURAL DELAYS REPORTED DUE TO THE RUPTURE DISCOVERED DURING THE REVISION SURGERY. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17777195 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT AND SUFFERED RIGHT SIDE CHEST INJURY AS SHE BUMPED IN A COUNTER, AND EXPERIENCED RIGHT SIDE NECROSIS, AND WOUND INFECTION, POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6), 2022.

  Patient problems: Necrosis; Post Operative Wound Infection

  MAUDE report 17408438 ↗
• InjuryFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED TENDERNESS IN HER LEFT BREAST. MAGNETIC RESONANCE IMAGING AND AN ULTRASOUND CONFIRMED THAT HER LEFT PROSTHESIS WAS RUPTURED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16376359 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 600CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16009221 ↗
• InjuryAug 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED BILATERAL BREAST IMPLANT RUPTURES, POST-OPERATIVELY. 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: Deformity/ Disfigurement

  MAUDE report 15170190 ↗
• InjuryAug 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED BILATERAL BREAST IMPLANT RUPTURES, POST-OPERATIVELY. 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: Deformity/ Disfigurement

  MAUDE report 15170108 ↗
• InjuryApr 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYGEL, 600CC BREAST IMPLANT HAS EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE POSTOPERATIVELY. THE ULTRASOUND EXAMINATION SHOWED THE RUPTURE, ITS GROWN UP 3 SIZES, WITH PAIN. THE FLUID WAS ASPIRATED FOR TESTING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Local Reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167767 ↗
• InjuryMar 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. THE PATIENT EXPERIENCED A BUMP IN HER RIGHT BREAST, AND MAMMOGRAM PERFORMED ON (B)(6) 2022 INDICATED RIGHT-SIDED RUPTURE. THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL ON (B)(6) 2022, AND A PRE-OPERATIVE CONSULTATION ON (B)(6) 2022. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. UPON EXPLANTATION, BILATERAL RUPTURE WAS OBSERVED. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13878332 ↗