MENTOR MemoryGel Breast Implant 3545430Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317007159), received between Sep 25, 2019 and Dec 12, 2025 — classified as 5 injuries, 3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23795277 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 430CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A PRIMARY BREAST RECONSTRUCTION SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. 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 23007708 ↗
• MalfunctionOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 430 CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED DURING A PRIMARY BREAST AUGMENTATION WHILE BEING INSERTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20572743 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM AND MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18753501 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 430CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED INTRA-OPERATIVELY. THE IMPLANT RUPTURED AFTER IT WAS IMPLANTED. AS A RESULT, ANOTHER IMPLANT, A 400CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3545400 LOT: 9663528 SN: (B)(4) WAS IMPLANTED. NO ADVERSE EVENT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108426 ↗
• InjuryApr 15, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 430CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 480CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED SEVERAL HEALTH ISSUES POST PROCEDURE. BILATERAL CAPSULAR CONTRACTURE, BILATERAL SEROMA, INFECTION, AND AUTOIMMUNE DISORDERS WERE ALL NOTED. AFTER A MAMMOGRAM IDENTIFIED AN ISSUE, AN ULTRASOUND WAS RECOMMENDED. THE ULTRASOUND WAS PERFORMED AT THE END OF (B)(6) 2020 AND REVEALED THAT SEROMAS AND EFFUSIONS WERE SURROUNDING THE IMPLANTS. THE CAPSULAR CONTRACTURE WAS IDENTIFIED BY A PHYSICIAN EXAMINATION. THE PHYSICIAN INDICATED THE DEGREE OF CAPSULAR CONTRACTURE WAS LIKELY BAKER GRADE IV BY STATING THAT THE CONTRACTURE WAS THE HIGHEST SEVERITY. THE PATIENT WAS DIAGNOSED WITH RAYNAUD¿S AND WAS EXPERIENCING PINS AND NEEDLE SENSATIONS IN HER HANDS. ADDITIONALLY, THE PATIENT HAD RASHES OVER HER BODY, INSOMNIA, HER LYMPH SYSTEM WAS UNABLE TO DRAIN, CHRONIC FATIGUE, RED EYES, AND SICKLY APPEARANCE. THE PATIENT WAS UNABLE TO WORK DUE TO THESE ISSUES. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE DEVICES WERE EXPLANTED WITHOUT REPLACEMENT AND THE PATIENT REPORTED AN IMPROVEMENT

  Patient problems: Autoimmune Reaction; Capsular Contracture; No Code Available; Seroma; Unspecified Infection

  MAUDE report 9963881 ↗
• InjurySep 25, 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 PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 430CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING WEIGHT GAIN AND DIFFICULTY LOSING WEIGHT, DRY EYES, VERY FATIGUED, CLOUDY EYES, VISION BURRING VERY QUICKLY, FACE IS ALWAYS PUFFY AND SWOLLEN ON THE LOWER HALF, PHOTOSENSITIVE (RASH ON FACE AND ARMS), BRAIN FOG, LUMPS IN RIGHT BREAST, CALCIFICATION ON THE LEFT BREAST, SHORTNESS OF BREATH AND TIGHTNESS OF CHEST. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9119587 ↗
• InjurySep 25, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 430CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING WEIGHT GAIN AND DIFFICULTY LOSING WEIGHT, DRY EYES, VERY FATIGUED, CLOUDY EYES, VISION BURRING VERY QUICKLY, FACE IS ALWAYS PUFFY AND SWOLLEN ON THE LOWER HALF, PHOTOSENSITIVE (RASH ON FACE AND ARMS), BRAIN FOG, LUMPS IN RIGHT BREAST, CALCIFICATION ON THE LEFT BREAST, SHORTNESS OF BREATH AND TIGHTNESS OF CHEST. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9119586 ↗