MENTOR MemoryGel Breast Implant 3507501BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00081317003854), received between Aug 28, 2018 and Apr 7, 2026 — classified as 72 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (41 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 74 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED PTOSIS ON THE LEFT SIDE ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24802582 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS WAS POSSIBLY RUPTURED BY THE SURGEON, BUT THE REPORTER WAS UNSURE. THE EVENT OCCURRED PRE-OPERATIVELY WITHOUT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324959 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS HAD A SLIT IN IT WHEN PULLED FROM CONSIGNMENT. THE EVENT OCCURRED PRE-OPERATIVELY WITHOUT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324942 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22413778 ↗
• InjuryJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22285765 ↗
• InjuryJan 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM/SONOGRAM AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 21134101 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 750CC AND EXPERIENCED ANISOMASTIA ON THE RIGHT SIDE AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21103659 ↗
• InjuryNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 750CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20798304 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE WAS CREATED TO DOCUMENT THE IMMEDIATE SEND ALERT BREAST-Q AUGMENTATION (POST-OPERATIVE) 1 YEAR FOLLOW-UP. [ADVERSE EVENT REVIEW CLINICAL NOTE AND PATIENT CODING VERIFICATION]: CODING WAS VERIFIED ON MAY-31-2024 PER 100553403 AND 100553401 WITH THE AVAILABLE INFORMATION ABOUT THE REPORTABLE EVENT. DURING THE 1 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST PAIN AND BREAST RIPPLING (WRINKLING).

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 19478703 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING WEIRD SENSATIONS AND CONSTRICTIONS ASSOCIATED WITH HER BREASTS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01283 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 18647227 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING WEIRD SENSATIONS AND CONSTRICTIONS ASSOCIATED WITH HER BREASTS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01285 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 18647225 ↗
• InjuryJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 750CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18609924 ↗
• InjuryNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. 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: Deformity/ Disfigurement

  MAUDE report 18142693 ↗
• InjuryNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. 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 18142691 ↗
• InjurySep 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICE WAS A 750CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3507501BC LOT: 9435607 SN: (B)(6)).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17828994 ↗
• InjurySep 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WITHOUT REPLACEMENT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 17819456 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST IMPLANTATION SURGERY WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, ONE OF THE PATIENT'S UNSPECIFIED BREAST LOOKED AND SAT DIFFERENT FROM THE OTHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SINCE IT WAS NOT SPECIFIED WHICH BREAST HAS THE COMPLICATION, BOTH THE RIGHT AND LEFT SERIAL NUMBERS WERE PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE CLARIFICATION IS RECEIVED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17637037 ↗
• InjuryJul 11, 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 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 800CC (LEFT) AND A 750CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT AND MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6)2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17301671 ↗
• InjuryApr 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED FEELING A LUMP AND SLOWLY WAS GETTING LARGER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16820141 ↗
• InjuryApr 17, 2023Migration; Migration

  IT WAS REPORTED THAT A 34-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A DEVICE MIGRATION ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE 4 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

  MAUDE report 16752725 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 750CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 16630071 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN 800CC (LEFT), 750CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3-4 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: Capsular Contracture

  MAUDE report 16584533 ↗
• InjuryFeb 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 750CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS (RIGHT DEVICE) AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING INFLAMMATION, ELEVATED RA LEVELS, FATIGUE, BODY ACHES, JOINT PAIN, PAIN ON THE LEFT SIDE UNDER THE RIBCAGE AREA, AND UNSPECIFIED AUTOIMMUNE DISORDERS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT BREAST PROSTHESIS RUPTURED AND THAT THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. THE PATIENT CAN FEEL THE FOLD OF HER LEFT BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

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

  MAUDE report 16342105 ↗
• InjuryFeb 1, 2023Migration; Migration

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 750CC GEL BREAST PROSTHESES THAT BOTH MIGRATED POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT¿S BREASTS WERE FALLING DOWN TO HER STOMACH AND INTO HER ARMPITS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 585CC GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16279941 ↗
• InjuryFeb 1, 2023Migration; Migration

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 750CC GEL BREAST PROSTHESES THAT BOTH MIGRATED POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT¿S BREASTS WERE FALLING DOWN TO HER STOMACH AND INTO HER ARMPITS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 585CC GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16279939 ↗