MENTOR MemoryGel Breast Implant 3545557MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317004509), received between Sep 20, 2019 and Jul 14, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST 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 22502297 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 22501303 ↗
• InjuryMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN ULTRASOUND. AS A RESULT, THE PATIENT WAS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 19264501 ↗
• InjuryDec 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD NON-HISPANIC FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 555CC GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. LEFT BREAST PROSTHESIS RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, IT WAS REPORTED THAT THE MRI RESULTS SHOWED FLUID IN BOTH OF THE BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 15925869 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71-YEAR-OLD NON-HISPANIC FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 555CC GEL BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. LEFT BREAST PROSTHESIS RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, IT WAS REPORTED THAT THE MRI RESULTS SHOWED FLUID IN BOTH OF THE BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 15925804 ↗
• InjuryJun 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 555CC MENTOR MEMORYGEL BREAST IMPLANT AND 595CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE AND LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE II. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14637270 ↗
• InjurySep 20, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-IP-00377884. IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION REVISION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANTS ON 12/11/2014 DEVELOPED BILATERAL RUPTURE THAT WAS OBSERVED ON (B)(6) 2018. SEROMA AND GENERALIZED ILLNESS WERE ALSO REPORTED. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH CATALOG NUMBER 3545557MC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE AND WITH CATALOG NUMBER 3545557MC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE ON (B)(6) 2018. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Code Available; Seroma

  MAUDE report 9098079 ↗
• InjurySep 20, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION REVISION WITH 555CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2014 DEVELOPED BILATERAL RUPTURE THAT WAS OBSERVED ON (B)(6) 2018. SEROMA AND GENERALIZED ILLNESS WERE ALSO REPORTED. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH CATALOG NUMBER: 3545557MC; SERIAL NUMBER: (B)(4) ON THE RIGHT SIDE AND WITH CATALOG NUMBER: (B)(4); SERIAL NUMBER: (B)(4) ON THE LEFT SIDE ON (B)(6) 2018. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available; Seroma

  MAUDE report 9098078 ↗