MENTOR MemoryGel Breast Implant 3507125BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317000020), received between Sep 18, 2019 and Oct 3, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. LASTLY, THE PATIENT DEVELOPED A CYST ON HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 350CC GEL BREAST PROSTHESIS ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20364058 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT FEEL UNCOMFORTABLE WITH THE PROJECTION OF THE IMPLANTS AND DISLIKES HOW THEY LOOK FROM THE SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 18496702 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 125CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT FEEL UNCOMFORTABLE WITH THE PROJECTION OF THE IMPLANTS AND DISLIKES HOW THEY LOOK FROM THE SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 18494584 ↗
• InjuryFeb 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 76-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL,125CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POST PROCEDURE. THE MRI SHOWS RUPTURES IN EACH BREAST. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16280737 ↗
• InjuryMar 18, 2022Adverse 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 A BREAST RECONSTRUCTION WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13804244 ↗
• InjuryMar 17, 2020Adverse 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 BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 125CC (LEFT) AND AN UNSPECIFIED MENTOR IMPLANT (RIGHT) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, A RUPTURE ON THE RIGHT SIDE, AND SYMPTOMS INCLUDING DISCOMFORT, BLACK AND BLUE SKIN, AND THE INABILITY TO DO ANY HEAVY LIFTING POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9843132 ↗
• InjuryFeb 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 125CC AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9682651 ↗
• InjuryDec 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 125CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. A MAGNETIC RESONANCE IMAGERY WAS PERFORMED ON (B)(6) 2019 WHICH CONFIRMED RIGHT SIDED RUPTURE. PATIENT ALSO EXPERIENCED RIGHT SIDED SWOLLENNESS. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 9445016 ↗
• InjurySep 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 125CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS. JOINT PAIN, PALPITATIONS, UPPER GASTROINTESTINAL ISSUES, LYMPH NODE REMOVAL, IMPAIRED HEARING, RIGHT SHOULD PAIN, NECK PAIN, LOWER BACK PAIN, CHEST PAIN, ANEMIA, LOW VITAMIN D, BRAIN FOG, PANIC ATTACKS, LEG NUMBNESS, DEPRESSION, SWELLING, WEIGHT GAIN, COLD HANDS, AND LEFT BREAST DROPPING WERE ALL NOTED. A SONOGRAM AND HEART MONITORING WERE PERFORMED, BUT THE RESULTS WERE NOT PROVIDED. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THE DEVICES WERE REMOVED WITHOUT REPLACEMENT ON (B)(6) 2019. SEE 1645337-2019-19585 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 9082178 ↗
• InjurySep 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 HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 125CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS. JOINT PAIN, PALPITATIONS, UPPER GASTROINTESTINAL ISSUES, LYMPH NODE REMOVAL, IMPAIRED HEARING, RIGHT SHOULD PAIN, NECK PAIN, LOWER BACK PAIN, CHEST PAIN, ANEMIA, LOW VITAMIN D, BRAIN FOG, PANIC ATTACKS, LEG NUMBNESS, DEPRESSION, SWELLING, WEIGHT GAIN, COLD HANDS, AND LEFT BREAST DROPPING WERE ALL NOTED. A SONOGRAM AND HEART MONITORING WERE PERFORMED, BUT THE RESULTS WERE NOT PROVIDED. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THE DEVICES WERE REMOVED WITHOUT REPLACEMENT ON (B)(6) 2019. SEE 1645337-2019-19584 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 9082177 ↗