MENTOR MemoryGel Breast Implant 3507150BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00081317000037), received between Aug 15, 2019 and May 26, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION, AS PART OF A CLINICAL STUDY, WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT HAD TO UNDERGO BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY, FOR UNSPECIFIED REASONS, ON (B)(6) 2025. DURING THE SURGERY, BOTH THE LEFT AND RIGHT IMPLANTS WERE IDENTIFIED TO HAVE RUPTURED. SUBSEQUENTLY, THEY WERE REPLACED WITH TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22085232 ↗
• InjuryMar 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18872204 ↗
• InjuryMar 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18872203 ↗
• InjuryDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18345773 ↗
• InjuryNov 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023 FOR AN UNDISCLOSED REASON. DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18084900 ↗
• InjuryOct 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-12801 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18025594 ↗
• InjuryOct 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-12802, FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18025588 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-07806 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17255173 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-07805 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17254950 ↗
• InjuryMar 21, 2023Adverse 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 AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE HAD AN ENCAPSULATED LEFT BREAST. CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, NO BAKER GRADE RATING WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 16584700 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE LEFT SIDE AND 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. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16530781 ↗
• InjuryMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE LEFT SIDE AND 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. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16530764 ↗
• InjuryDec 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD WHITE FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY FOR AN UNDISCLOSED REASON ON (B)(6) 2022. DURING THE SURGERY, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. THERE WERE NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCES REPORTED DUE TO THE RUPTURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 350CC (LEFT-SIDED) AND 450CC (RIGHT-SIDED) MENTOR MEMORYGEL BREAST IMPLANTS. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-14629 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15915387 ↗
• InjuryNov 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST AND SUFFERED LEFT BREAST IMPLANT RUPTURE, 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 15889274 ↗
• InjuryNov 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING A BILATERAL EXPLANTATION SURGERY ON (B)(6) 2022. THE REMOVED BREAST PROSTHESES WERE NOT REPLACED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15718294 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANTS AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED AT AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14684383 ↗
• InjuryMay 13, 2022Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 150CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THAT HER RIGHT IMPLANT WAS MIGRATING UP TOWARDS HER COLLAR BONE. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14397165 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 150CC ON THE LEFT AND 200CC ON THE RIGHT SIDE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POST PROCEDURE. THE MATTER WAS DIAGNOSED THROUGH PHYSICAL EXAMINATIONS. 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.

  Patient problems: Capsular Contracture

  MAUDE report 12829064 ↗
• InjuryJul 28, 2021Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE LEFT SIDE POST-OPERATIVELY, WHICH REQUIRED SURGICAL INTERVENTION. THE ATTENDING SURGEON REMOVED AND REINSERTED THE IMPLANT TO ADJUST THE POCKET, WHICH IS CONSIDERED OFF LABEL USE OF THE DEVICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12240220 ↗
• InjuryJul 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12233764 ↗
• InjuryNov 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED SILENT RUPTURE POST PROCEDURE. A MAGNETIC RESONANCE IMAGING WAS PERFORMED ON (B)(6) 2019 CONFIRMING RIGHT SIDED RUPTURE. 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 9336488 ↗
• InjuryAug 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 150CC MENTOR SMOOTH ROUND MODERATE PROFILE MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. A MAGNETIC RESONANCE IMAGERY WAS PERFORMED IN (B)(6) 2019 WHICH CONFIRMED LEFT SIDE BREAST RUPTURE. AS A RESULT, THE PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8897674 ↗