MENTOR MemoryGel Breast Implant 3545507Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00081317000747), received between Feb 9, 2018 and Nov 13, 2025 — classified as 48 injuries.

The most frequently reported specific device problem is “Material Rupture” (29 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND GRADE 2 ON THE RIGHT) POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23544872 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND GRADE 2 ON THE RIGHT) POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23544870 ↗
• InjuryMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A AN UNSPECIFIED MENTOR TEXTURED GEL IMPLANT EXPERIENCED A RUPTURE AND RECURRING BREAST CANCER POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Cancer; Seroma

  MAUDE report 21731804 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 550CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES OF UNKNOWN GRADE POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT. THIS REPORT SPECIFICALLY PERTAINS TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21470773 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL, 550CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES OF UNKNOWN GRADE POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT. THIS REPORT SPECIFICALLY PERTAINS TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21470750 ↗
• InjuryJul 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19757327 ↗
• InjuryJul 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19757326 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18419737 ↗
• InjuryAug 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM AND ULTRASOUND, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE (RIGHT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 9878154 SN: (B)(6) AND (LEFT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 9783584 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17579258 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAMMOGRAM, ULTRASOUND, AND COMPUTED TOMOGRAPHY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Seroma

  MAUDE report 16498736 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 600CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED LEFT SIDED RUPTURE, LEFT SIDED GRANULOMA, LEFT SIDED BREAST PAIN, AND RIGHT SIDED PTOSIS POST PROCEDURE. MAGNETIC RESONANCE IMAGING, MAMMOGRAPHY, AND ULTRASOUND DETECTED THE PRESENCE OF GRANULOMA AND RUPTURE. THE PTOSIS WAS ASSOCIATED WITH A DEFORMITY IN WHICH THE BREAST IMPLANT WAS SITTING HIGH ON THE CHEST WALL. AS A RESULT, EXPLANT IS SCHEDULED FOR (B)(6) 2022. SEE 1645337-2022-14998 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 15971792 ↗
• InjuryDec 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15896140 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 550CC MENTOR SILTEX CLINICAL GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED LUMPS ON THE LOWER SIDE OF THE RIGHT BREAST. UPON CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS CONFIRMED TO HAVE ENLARGED LYMPH NODES. AS A RESULT, SHE HAD A BIOPSY PERFORMED AND IT WAS CONFIRMED THAT THE RIGHT BREAST IMPLANT WAS RUPTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III AND II CAPSULAR CONTRACTURE OF THE RIGHT AND LEFT BREAST, RESPECTIVELY. 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12654 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 15642801 ↗
• InjuryOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 550CC MENTOR SILTEX CLINICAL GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED LUMPS ON THE LOWER SIDE OF THE RIGHT BREAST. UPON CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS CONFIRMED TO HAVE ENLARGED LYMPH NODES. AS A RESULT, SHE HAD A BIOPSY PERFORMED AND IT WAS CONFIRMED THAT THE RIGHT BREAST IMPLANT WAS RUPTURED. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III AND II CAPSULAR CONTRACTURE OF THE RIGHT AND LEFT BREAST, RESPECTIVELY. 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12655 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 15642543 ↗
• InjuryOct 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR MEMORYGEL, 550CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY. THE MRI EXAMINATION CONFIRMED THE ISSUE, AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15555787 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15423385 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15423383 ↗
• InjuryAug 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND BREAST MASS ON HER RIGHT SIDE POSTOPERATIVELY; CONFIRMED VIA MAMMOGRAM AND ULTRASOUND. MRI IS PENDING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 15323163 ↗
• InjuryApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 550CC BREAST IMPLANT EXPERIENCED LEFT-SIDED RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13980717 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY AND BREAST PAIN 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 13578625 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY AND BREAST PAIN 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 13578618 ↗
• InjuryJan 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A MAMMOGRAM AND A PHYSICAL. ADDITIONALLY, BAKER GRADE III CAPSULAR CONTRACTURE IN THE RIGHT BREAST WAS DIAGNOSED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2021. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DISCOVERED DURING EXPLANT SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13366459 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST, SUFFERED LEFT BREAST IMPLANT RUPTURE, POST-PROCEDURE. THE RUPTURE WAS DISCOVERED VIA CT SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12906086 ↗
• InjuryNov 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A MAMMOGRAM AND A PHYSICAL. ADDITIONALLY, BAKER GRADE III CAPSULAR CONTRACTURE IN THE RIGHT BREAST WAS DIAGNOSED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12866231 ↗
• InjuryAug 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC AND SUFFERED BILATERAL GENERALIZED ILLNESS, LOCAL REACTION, LYMPHADENOPATHY, RUPTURE. THE PATIENT EXPERIENCED BREAST SWELLING IN THE LEFT BREAST AND MILK PRODUCTION IN BOTH BREASTS, FATIGUE, DIZZINESS, VERTIGO, FEELING OF NUMBNESS IN ARMS AT TIMES, LYMPH NODES IN GROIN AND LEFT ARM ARE SWOLLEN. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Local Reaction; Swollen Lymph Nodes/Glands

  MAUDE report 12303637 ↗