MENTOR MemoryGel Breast Implant 3544300Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00081317001041), received between Mar 14, 2018 and May 6, 2026 — classified as 53 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (25 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RUPTURES, BREAST PAIN, A GRANULOMA, AND IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095510 ↗
• InjuryMay 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RUPTURES, BREAST PAIN, A GRANULOMA, AND IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

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

  MAUDE report 25095506 ↗
• InjuryMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22004114 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21679184 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21679183 ↗
• InjuryOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20359265 ↗
• InjurySep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED 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: Deformity/ Disfigurement

  MAUDE report 20269033 ↗
• InjuryJun 3, 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 AN UNKNOWN MENTOR SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV POST-OPERATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19449413 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE, BILATERAL BREAST MALPOSITION, BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND UNSPECIFIED BAKER GRADE ON THE LEFT). THE BREASTS WERE TOO HIGH, VERY FIRM BUT WORST ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19310972 ↗
• InjuryMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE, BILATERAL BREAST MALPOSITION, BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND UNSPECIFIED BAKER GRADE ON THE LEFT). THE BREASTS WERE TOO HIGH, VERY FIRM BUT WORST ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19310969 ↗
• InjuryJan 3, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT LEAKS/RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18439653 ↗
• InjuryAug 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 300CC SILICONE IMPLANT EXPERIENCED LEFT-SIDED SILENT RUPTURE POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH UNSPECIFIED MENTOR SILICONE PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17552405 ↗
• InjuryJun 30, 2023Adverse 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 IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT FELL ON HER RIGHT BREAST. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 17240209 ↗
• InjuryJun 7, 2023Adverse 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 AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17083721 ↗
• InjuryJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED EITHER POSSIBLY A BREAST CYST OR RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT REPORTED THAT ¿SILICONE CYSTS¿ WAS FOUND VIA A SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s)

  MAUDE report 17081926 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED BREAST PAIN AND RIPPLING ON THE RIGHT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH A ¿KNOCKING SOUND¿ ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT IS ALSO EXPERIENCING DEPRESSION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6), 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Emotional Changes; Wrinkling

  MAUDE report 16691563 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 300CC AND EXPERIENCED BREAST PAIN AND RIPPLING ON THE RIGHT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH A ¿KNOCKING SOUND¿ ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT IS ALSO EXPERIENCING DEPRESSION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6), 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Emotional Changes

  MAUDE report 16691553 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 300CC MENTOR MEMORYGEL BREAST IMPLANT PLACED EXPERIENCED BILATERAL BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-04019 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16686842 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 300CC MENTOR MEMORYGEL BREAST IMPLANT PLACED EXPERIENCED BILATERAL BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-04018 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16686841 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 370CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023. 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 16631719 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED MENTOR GEL IMPLANT ON THE RIGHT BREAST, WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16628520 ↗
• InjuryFeb 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY; CONFIRMED VIA MAMMOGRAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16303871 ↗
• InjuryFeb 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT AND CAPSULAR CONTRACTURE OF THE RIGHT BREAST. NO BAKER GRADE RATING WAS PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH SIENTRA BREAST IMPLANTS ON (B)(6) 2022. ADDITIONALLY, PERI-IMPLANT FLUID WAS ASPERATED FROM THE RIGHT BREAST AND SENT FOR CULTURE. NO INDICATIONS ABOUT THE FLUID WERE PROVIDED.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279780 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300 CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. THE PATIENT REPORTED PAIN AND TIGHTNESS. 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: Capsular Contracture

  MAUDE report 15067074 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300 CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. THE PATIENT REPORTED PAIN AND TIGHTNESS. 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: Capsular Contracture

  MAUDE report 15067051 ↗