MENTOR MemoryGel Xtra Breast Implant TMPX295Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317025450), received between Apr 13, 2021 and Sep 3, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED A BACKUP DEVICE, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955341 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT RUPTURED DURING A PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776426 ↗
• InjuryMar 20, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 295CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III 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. SEE MANUFACTURER REPORT NUMBER 1645337-2024-03398 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18941630 ↗
• InjuryMar 20, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 295CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON FEB 19, 2024.THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.SEE MANUFACTURER REPORT NUMBER 1645337-2024-03397 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18941625 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 295CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 325CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17384244 ↗
• InjuryApr 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE WITH BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT HAD AN EVENT WITH THE PREVIOUS SET OF IMPLANTS REPORTED UNDER 1645337-2023-04785.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16817343 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16584131 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE RIGHT SIDE 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 16109094 ↗
• InjuryNov 14, 2022Adverse 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 SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. 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: Capsular Contracture

  MAUDE report 15788231 ↗
• InjuryOct 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12573897 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED DISSATISFACTION OF IMPLANT ON AN UNSPECIFIED SIDE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12059617 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON ONE SIDE, AND WITH 325CC MENTOR MEMORYGEL BREAST IMPLANT ON THE OTHER SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE DEVICE WERE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 11789573 ↗
• InjuryApr 28, 2021Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A 295CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST ON (B)(6) 2021, SUFFERED RIGHT BREAST IMPLANT DISPLACEMENT/MIGRATION, POST-PROCEDURE. THE DISPLACEMENT/MIGRATION WAS DIAGNOSED VIA AN ULTRASOUND ON THE SAME DAY ((B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT IMPLANT EXPLANTATION AND REPLACEMENT WITH A 270CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (TMPX270 LOT: 7624729 SN: (B)(4)).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11741856 ↗
• InjuryApr 13, 2021Adverse 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 IMPLANTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 295CC AND SUFFERED FROM AN EARLY ONSET SEROMA ON THE LEFT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: Seroma

  MAUDE report 11658177 ↗