MENTOR MemoryGel Breast Implant 3541757Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317000624), received between Apr 26, 2019 and Oct 17, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 150CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 175CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12211 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17951283 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 175CC AND EXPERIENCED BILATERAL BREAST PAIN AND ANISOMASTIA 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 16208770 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 175CC AND EXPERIENCED BILATERAL BREAST PAIN AND ANISOMASTIA 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 BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 16208713 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION RECONSTRUCTION REVISION SURGERY WITH A 175CC (LEFT) AND A 200CC (RIGHT) AND MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 14289070 ↗
• InjuryNov 16, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 200CC ON THE RIGHT AND 175CC ON THE LEFT SIDE BREAST IMPLANT EXPERIENCED RIGHT-SIDED RUPTURE, GRANULOMA, WRINKLING, BILATERAL SITE CALCIFICATION, AND BILATERAL LOCAL REACTION POST PROCEDURE. THE MRI EXAMINATION REPORTED SILICONE IN THE LYMPH GLANDS, NIPPLE WAS INVERTED, AND CONFIRMED BILATERAL LOCAL REACTIONS, AND ULTRASOUNDS EXAMINATIONS CONFIRMED BILATERAL IMPLANT SITE CALCIFICATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS. NOTE: ADJACENT STUDY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Capsular Contracture; Local Reaction

  MAUDE report 12824224 ↗
• InjuryDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT AND A 200CC MENTOR MEMORYGEL BREAST IMPLANT AN UNKNOWN DATE EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-16021 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11024536 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED RIGHT-SIDED RUPTURE AND LEFT-SIDED CUTANEOUS CONTOUR DEFORMITY POSTOPERATIVELY. MRI PERFORMED ON (B)(6) 2020 INDICATED RIGHT-SIDED RUPTURE. IN ADDITION, THE HEALTHCARE PROFESSIONAL REPORTED THAT THAT A FEW LEFT FOLDS WERE OBSERVED. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION AND PRE-OP SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS ESTIMATED AS (B)(6) 1998 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Rupture

  MAUDE report 10971988 ↗
• InjuryDec 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 175CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED RIGHT-SIDED RUPTURE AND LEFT-SIDED CUTANEOUS CONTOUR DEFORMITY POSTOPERATIVELY. MRI PERFORMED ON (B)(6) 2020 INDICATED RIGHT-SIDED RUPTURE. IN ADDITION, THE HEALTHCARE PROFESSIONAL REPORTED THAT A FEW LEFT FOLDS WERE OBSERVED. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION AND PRE-OP SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS ESTIMATED AS (B)(6) 1998 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10971919 ↗
• InjuryAug 24, 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 WITH MENTOR MEMORYGEL BREAST IMPLANT 175 CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10444459 ↗
• InjuryOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC AND EXPERIENCED BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2019. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9226077 ↗
• InjuryOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC AND EXPERIENCED BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2019. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9226066 ↗
• InjuryOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 175CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED SILENT RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 325CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9202649 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC (L) AND 175CC (R) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-00154654.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9111760 ↗
• InjuryJun 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 8736837 ↗
• InjuryApr 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESES ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8556000 ↗