MENTOR MemoryGel Xtra Breast Implant THPX765Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317025801), received between Jan 23, 2019 and Oct 29, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 765CC AND EXPERIENCED RASH, BURNING, RASH INCREASED TO SHOULDER/MIDBACK/HIGH BREAST AREA/NECK/FACE, ITCHY/DRY/RED/STINGING EYES, EARS ARE RINGING, ALLERGIC REACTION INSIDE, BRAIN FOG, AND INCREDIBLE ITCH/BURN POST-OPERATIVELY. PATIENT WAS PRESCRIBED DUPIXENT AND CELLCEP. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12723892 ↗
• InjuryOct 29, 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 765CC AND EXPERIENCED RASH, BURNING, RASH INCREASED TO SHOULDER/MIDBACK/HIGH BREAST AREA/NECK/FACE, ITCHY/DRY/RED/STINGING EYES, EARS ARE RINGING, ALLERGIC REACTION INSIDE, BRAIN FOG, AND INCREDIBLE ITCH/BURN POST-OPERATIVELY. PATIENT WAS PRESCRIBED DUPIXENT AND CELLCEP. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12723797 ↗
• InjuryApr 29, 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 FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION ON (B)(6) 2018 WITH A 765CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT SIDE, SUFFERED BREAST INFECTION AND DEVICE EXTRUSION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A NEW 765CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG: THPX765 LOT: 7596016 SN: (B)(4)) ON (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 10012571 ↗
• InjuryJul 18, 2019Adverse 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 765CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED LEFT SIDED BAKER¿S GRADE III CAPSULAR CONTRACTURE AND RIGHT SIDED DROOPING POST PROCEDURE. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. SEE 3006942524-2019-00531 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8804499 ↗
• InjuryJul 18, 2019Adverse 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 765CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED LEFT SIDED BAKER¿S GRADE III CAPSULAR CONTRACTURE AND RIGHT SIDED DROOPING POST PROCEDURE. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. SEE 3006942524-2019-00530 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8804497 ↗
• MalfunctionJan 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR LIKE SUBSTANCE WAS FOUND ON MENTOR MEMORYGEL XTRA, SILTEX HIGH PROFILE, 765CC. NO PATIENT CONTACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271968 ↗