MENTOR MemoryGel Breast Implant 3545007Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00081317000730), received between Mar 7, 2018 and Jan 9, 2026 — classified as 104 injuries.

The most frequently reported specific device problem is “Material Rupture” (87 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 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM AND MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24023890 ↗
• InjuryJan 9, 2026Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM AND MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24023887 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 69-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM AND MAMMOGRAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23782602 ↗
• InjurySep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 530CC GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22965533 ↗
• InjuryApr 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE AND RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. DIAGNOSIS WAS MADE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21769711 ↗
• InjuryApr 3, 2025Material 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE AND RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. DIAGNOSIS WAS MADE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21769703 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3505001BC). THE PATIENT REPORTED TWO DEVICE SERIAL NUMBERS, HOWEVER, IT IS UNKNOWN WHICH SERIAL NUMBER BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 20919719 ↗
• InjuryNov 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20676039 ↗
• InjuryAug 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19943194 ↗
• InjuryFeb 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18722836 ↗
• InjuryFeb 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18722835 ↗
• InjuryJan 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18488374 ↗
• InjuryDec 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18421144 ↗
• InjuryDec 21, 2023Material Rupture; Material Rupture

  T WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 500CC MENTOR SILTEX ROUND MODERATE PROFILE MEMORYGEL BREAST IMPLANT ON (B)(6) 2002 EXPERIENCED EXTRACAPSULAR RUPTURE OF THE LEFT IMPLANT WITH LEFT AXILLAL LYMPH NODES CONTAINING SILICONE. THIS WAS FOUND DURING A MAMMOGRAM ON (B)(6) 2015, AND (B)(6) 2018. THE PATIENT HAD AN MRI ON (B)(6) 2018 THAT CONFIRMED THE RUPTURE. THE PATIENT ALSO HAS LYMPH NODE PAIN AND ITCHINESS IN LEFT BREAST AROUND THE NIPPLE AREA. THE PATIENT WILL HAVE LYMPH NODES REMOVED. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2023. NOTE: MENTOR RECEIVED TWO RUPTURED DEVICES WITH NO LOT NUMBERS, MENTOR INVESTIGATED BOTH DEVICES IN ORDER TO BE THROUGH AND CONSERVATIVES OF ALL POSSIBLE ISSUES MIGHT HAVE HAPPENED TO THE PATIENT. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 18377604 ↗
• InjuryDec 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 500CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE REPORTED DATE OF IMPLANTATION IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE SECOND OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2023-14945 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 18375715 ↗
• InjuryDec 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 500CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE REPORTED DATE OF IMPLANTATION IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE FIRST OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2023-14946 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 18367080 ↗
• InjurySep 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN UNSPECIFIED SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT REPORTED THE EVENT VIA SOCIAL MEDIA. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17814259 ↗
• InjuryAug 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A BREAST IMPLANT RUPTURE ON THE RIGHT SIDE CONFIRMED BY ULTRASOUND AND COMPLICATED BY A SILICONE GRANULOMA FORMATION IN THE RIGHT AXILLA REGION. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Granuloma

  MAUDE report 17495464 ↗
• InjuryAug 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-09187 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17476709 ↗
• InjuryAug 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-09186 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17476707 ↗
• InjuryJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-07514 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 17198258 ↗
• InjuryJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. 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 1645337-2023-07513 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 17198257 ↗
• InjuryMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16587680 ↗
• InjuryMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16587414 ↗
• InjuryFeb 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED GRANULOMA AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED GRANULOMA AND BREAST IMPLANT GEL BLEED ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 16297421 ↗