MENTOR MemoryGel Xtra Breast Implant TMPX405Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317025498), received between Nov 25, 2020 and May 7, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED HIGH AND FIRM BREASTS. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-05381 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 19263234 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED HIGH AND FIRM BREASTS. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-05380 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 19263221 ↗
• InjurySep 27, 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 AUGMENTATION SURGERY WITH A 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A HEMATOMA IN HER RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS 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: Hematoma

  MAUDE report 17825917 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 405CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III, BILATERAL SEROMA, AND BILATERAL INFECTION POST-OPERATIVELY. THE PATIENT REQUIRED ASPIRATION OF THE BREASTS DUE TO THE SEROMA FORMATION. THE PATIENT DEVICE UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-08390 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Post Operative Wound Infection; Seroma

  MAUDE report 17328126 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 405CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III, BILATERAL SEROMA, AND BILATERAL INFECTION POST-OPERATIVELY. THE PATIENT REQUIRED ASPIRATION OF THE BREASTS DUE TO THE SEROMA FORMATION. THE PATIENT DEVICE UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-08393 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Post Operative Wound Infection; Seroma

  MAUDE report 17327543 ↗
• InjuryDec 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT HAD UNDERGONE A BILATERAL BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF TWO 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESES. POST-OPERATIVELY, THE PATIENT OBSERVED THAT THEIR LEFT BREAST WAS HIGHER THAN THE RIGHT. A RUPTURE TO THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021. REFER TO MANUFACTURING REPORT NUMBER 1645337-2021-12981 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13053479 ↗
• InjuryNov 22, 2021Adverse 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 HAD UNDERGONE A BILATERAL BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF TWO 405CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESES. POST-OPERATIVELY, THE PATIENT OBSERVED THAT THEIR LEFT BREAST WAS HIGHER THAN THE RIGHT. AFTER A PHYSICAL EXAMINATION, THE HCP DIAGNOSED THE LEFT BREAST WITH BAKER GRADE IV CAPSULAR CONTRACTURE BY AN UNDISCLOSED METHODOLOGY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12858192 ↗
• InjuryNov 26, 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 BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 405CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 10908771 ↗
• InjuryNov 25, 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 BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 405CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 10906943 ↗