MENTOR MemoryGel Xtra Breast Implant THPX255Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317025658), received between Jul 28, 2020 and Sep 14, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 255cc MENTOR MemoryGel Xtra Breast Implant experienced bilateral capsular contracture Baker Grade 4 post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50756959 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 255cc MENTOR MemoryGel Xtra Breast Implant experienced bilateral capsular contracture Baker Grade 4 post-operatively. As a result, the patient underwent explantation on (b)(6)2026.

  Patient problems: Capsular Contracture

  MAUDE report 50756958 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 36-year-old Caucasian female patient underwent primary breast augmentation with 255cc MENTOR MemoryGel Xtra Breast Implant and experienced Capsular Contracture; Baker Grade III on her left side postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the device was explanted on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50476554 ↗
• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO 255 CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS BEING USED IN A PRIMARY BREAST AUGMENTATION PROCEDURE WERE FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169999 ↗
• MalfunctionJun 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO 255 CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS BEING USED IN A PRIMARY BREAST AUGMENTATION PROCEDURE WERE FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169998 ↗
• MalfunctionJun 4, 2025Product Quality Problem; Device Contamination with Chemical or Other Material; Product Quality Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE PACKAGING OF A 255CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS DURING A PRIMARY BREAST AUGMENTATION SURGERY. ADDITIONALLY, IT WAS INDICATED THAT THE TWO LAYER PLASTIC PACKAGING WAS DIFFICULT TO OPEN AND SEPARATE FROM ONE ANOTHER WAS SUPER GLUED TOGETHER. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142106 ↗
• MalfunctionJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL XTRA BREAST IMPLANT 255CC GEL BREAST PROSTHESIS RUPTURED DURING A SCHEDULED PRIMARY BREAST AUGMENTATION PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195711 ↗
• InjuryJul 28, 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 REVISION BREAST AUGMENTATION WITH 255CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV, PAIN, UNABLE TO LAY ON STOMACH DUE TO UNCOMFORTABLE FEELING, AND BURNING SENSATION ON BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 10336468 ↗
• InjuryJul 28, 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 REVISION BREAST AUGMENTATION WITH 255CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE IV, PAIN, UNABLE TO LAY ON STOMACH DUE TO UNCOMFORTABLE FEELING, AND BURNING SENSATION ON BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 10336467 ↗