MENTOR MemoryGel Breast Implant 3544057MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317004448), received between May 3, 2019 and Jun 7, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• InjuryJun 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 405CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22164184 ↗
• InjurySep 4, 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 405CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY, AND BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20141548 ↗
• InjurySep 4, 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 405CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULECTOMY, AND BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20141493 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 405CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. MRI RESULTS INDICATED RIGHT BREAST PROSTHESIS RUPTURE AS WELL AS HEMATOMA, FLUID AROUND IMPLANT, AND BREAST SWELLING. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST ¿SWELLED UP TO THE SIZE OF A VOLLEYBALL¿. THE RIGHT BREAST IS ¿VERY PAINFUL AND THE MUSCLE IS TEARING AND RIPPING¿. ADDITIONALLY, THE MRI RESULTS INDICATED THAT THERE WAS A TRACE AMOUNT OF PERIIMPLANT FLUID IN THE LEFT BREAST. LASTLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT BREAST BIOPSY IN 2015 AND THE RESULTS WERE BENIGN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2023-12764 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Fluid Discharge

  MAUDE report 18252787 ↗
• InjuryOct 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 405CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. MRI RESULTS INDICATED RIGHT BREAST PROSTHESIS RUPTURE AS WELL AS HEMATOMA, FLUID AROUND IMPLANT, AND BREAST SWELLING. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT BREAST ¿SWELLED UP TO THE SIZE OF A VOLLEYBALL¿. THE BREAST IS ¿VERY PAINFUL AND THE MUSCLE IS TEARING AND RIPPING¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 18017042 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 405CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE EXPERIENCE LYMPH NODE PAIN. UPON A CONSULTATION WITH A MEDICAL PROFESSIONAL, ULTRASOUND, X-RAY, AND MAGNETIC RESONANCE IMAGING, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT WITH ACCOMPANYING PALPABLE LUMPS IN THE RIGHT AXILLA. ADDITIONALLY, THE LEFT BREAST WAS ASYMMETRICAL AND THERE WAS A CYST PRESENT IN THE LEFT BREAST. 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12755 FOR THE CONTRALATERAL EVENT.

  Patient problems: Cyst(s); Deformity/ Disfigurement

  MAUDE report 15827374 ↗
• InjuryOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 31-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 405CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE EXPERIENCE LYMPH NODE PAIN. UPON A CONSULTATION WITH A MEDICAL PROFESSIONAL, ULTRASOUND, X-RAY, AND MAGNETIC RESONANCE IMAGING, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT. 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: Granuloma; Swollen Lymph Nodes/Glands

  MAUDE report 15676025 ↗
• InjuryAug 27, 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 UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANT 405CC AND EXPERIENCED A PAINFUL RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAS EXPERIENCED BILATERAL LATE ONSET SEROMA AND LYMPHADENOPATHY ON THE LEFT SIDE. BIOPSY FOR EVALUATION OF FLUID AROUND THE BREAST IMPLANTS AND ENLARGED NODES WAS PERFORMED ON (B)(6) 2020. NO PATHOLOGY RESULT HAVE BEEN PROVIDED. IT WAS ALSO REPORTED THAT SOME FAT NECROSIS WAS NOTED AROUND BREAST IMPLANT ON THE RIGHT SIDE. THE TISSUE WAS SENT TO PATHOLOGY, BUT NO PATHOLOGY RESULTS HAVE BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Necrosis; No Code Available; Seroma

  MAUDE report 10461475 ↗
• InjuryAug 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANT 405 CC AND EXPERIENCED A PAINFUL RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAS EXPERIENCED BILATERAL LATE ONSET SEROMA AND LYMPHADENOPATHY ON THE LEFT SIDE. BIOPSY FOR EVALUATION OF FLUID AROUND THE BREAST IMPLANTS AND ENLARGED NODES WAS PERFORMED ON (B)(6) 2020. NO PATHOLOGY RESULT HAVE BEEN PROVIDED. IT WAS ALSO REPORTED THAT SOME FAT NECROSIS WAS NOTED AROUND BREAST IMPLANT ON THE RIGHT SIDE. THE TISSUE WAS SENT TO PATHOLOGY, BUT NO PATHOLOGY RESULTS HAVE BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: No Code Available; Pain; Seroma; Swollen Lymph Nodes

  MAUDE report 10461472 ↗
• InjuryMar 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 405CC MENTOR MEMORYGEL BREAST IMPLANT, SUFFERED LEFT BREAST PAIN, BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III, POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION IN (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9779463 ↗
• InjuryMay 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR MEMORYGEL BREAST IMPLANT 405CC AND EXPERIENCED LEFT SIDE RUPTURE NOTICED DURING REVISION SURGERY. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH ON (B)(6) 2019. THE PATIENT HAS A HISTORY OF HYPOMASTIA.

  Patient problems: No Code Available

  MAUDE report 8577546 ↗