MENTOR MemoryGel Xtra Breast Implant TMPX525Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317025535), received between Sep 11, 2019 and Nov 30, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18238432 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. AIR BUBBLE FEELING IN THE LEFT BREAST, BLOODY STOOL, SKIN RASH ON FACE, EXTREME FATIGUE, JOINT PAIN, DIZZINESS, LOSS OF BALANCE, DIFFICULTY CONCENTRATING, ANXIETY, AND HAIR LOSS WERE NOTED. ADDITIONALLY, THE DEVICE WAS THOUGHT TO HAVE POSSIBLY FLIPPED ON THE LEFT SIDE. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-12426 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 17971201 ↗
• InjuryOct 19, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. AIR BUBBLE FEELING IN THE LEFT BREAST, BLOODY STOOL, SKIN RASH ON FACE, EXTREME FATIGUE, JOINT PAIN, DIZZINESS, LOSS OF BALANCE, DIFFICULTY CONCENTRATING, ANXIETY, AND HAIR LOSS WERE NOTED. ADDITIONALLY, THE DEVICE WAS THOUGHT TO HAVE POSSIBLY FLIPPED ON THE LEFT SIDE. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-12427 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 17971200 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH TWO 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 8995001 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH TWO 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL CUTANEOUS CONTOUR DEFORMITY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 8995000 ↗