MENTOR MemoryGel Breast Implant 3545650Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317007203), received between May 16, 2019 and Sep 2, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING AUTOIMMUNE ISSUES, RASHES, PAIN, AND FEELING SICK POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 22940783 ↗
• InjurySep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING AUTOIMMUNE ISSUES, RASHES, PAIN, AND FEELING SICK POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 22940064 ↗
• InjuryOct 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505650BC, LOT: 9994016, SN: (B)(6) AND (RIGHT) 650CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505650BC, LOT: 9994016, SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20579645 ↗
• InjuryJun 27, 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 WITH MENTOR MEMORYGEL BREAST IMPLANTS 650CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19624421 ↗
• InjuryMar 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A MENTOR GEL BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18899800 ↗
• InjuryMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 650CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DIAGNOSED AT THE PHYSICIAN¿S OFFICE AND INDICATED THROUGH ULTRASOUND. ADDITIONALLY, ULTRASOUND IDENTIFIED THAT A 3.3CM BENIGN SILICONE GRANULOMA WAS NOTED WITHIN THE RIGHT AXILLARY LYMPH NODE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 750CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-05085 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Granuloma

  MAUDE report 14287363 ↗
• InjuryMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 650CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DIAGNOSED AT THE PHYSICIAN¿S OFFICE AND INDICATED THROUGH ULTRASOUND. ADDITIONALLY, ULTRASOUND IDENTIFIED THAT A 3.3CM BENIGN SILICONE GRANULOMA WAS NOTED WITHIN THE RIGHT AXILLARY LYMPH NODE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 750CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-05084 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14287265 ↗
• InjuryMay 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SILTEX UHP 650CC, DATE OF IMPLANT (B)(6) 2016) DEVELOPED LATE-ONSET SEROMA IN BOTH BREASTS AND ALSO HAS EXPERIENCED ASYMMETRY AND SWELLING OF THE LEFT BREAST. DURING EXPLANTATION ON (B)(6) 2021 HCP FOUND BILATERALLY RUPTURED IMPLANTS, ALONG WITH GROWTHS/TUMORS ON RIBS, A BIOPSY OF GROWTHS WAS PERFORMED AND SENT TO PATHOLOGY. PER THE PROVIDED PATHOLOGY RESULT, NO TUMOR WAS CONFIRMED, HISTIOCYTIC REACTION TO HYDROPHOBIC FOREIGN MATERIAL, AND NONSPECIFIC CHRONIC INFLAMMATION WAS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Breast Mass; Seroma

  MAUDE report 11845669 ↗
• InjuryMay 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42(B)(6) FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SILTEX UHP 650CC, DATE OF IMPLANT (B)(6) 2016) DEVELOPED LATE-ONSET SEROMA IN BOTH BREASTS AND ALSO HAS EXPERIENCED ASYMMETRY AND SWELLING OF THE LEFT BREAST. DURING EXPLANTATION ON (B)(6) 2021 HCP FOUND BILATERALLY RUPTURED IMPLANTS, ALONG WITH GROWTHS/TUMORS ON RIBS, A BIOPSY OF GROWTHS WAS PERFORMED AND SENT TO PATHOLOGY. PER THE PROVIDED PATHOLOGY RESULT, NO TUMOR WAS CONFIRMED, HISTIOCYTIC REACTION TO HYDROPHOBIC FOREIGN MATERIAL, AND NONSPECIFIC CHRONIC INFLAMMATION WAS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Breast Mass; Deformity/ Disfigurement; Seroma

  MAUDE report 11842996 ↗
• InjuryNov 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. THE PATIENT HAD AN ULTRASOUND PERFORMED DUE TO OBSERVED LUMPS AND FINDINGS SHOWED RIGHT BREAST PROSTHESIS RUPTURE. THE ULTRASOUND ALSO SHOWED THAT THE PATIENT DEVELOPED AREAS OF FAT NECROSIS ON HER RIGHT BREAST AS WELL AS A BENIGN, PALPABLE OIL CYST. ADDITIONALLY, THE RUPTURE WAS DIAGNOSED BY A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s); Necrosis

  MAUDE report 10833491 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED FOLD AND FLUID LOSS POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH LIKE DEVICE ON (B)(6) 2020.

  Patient problems: Local Reaction; No Code Available; Wrinkling

  MAUDE report 10757257 ↗
• InjuryMay 16, 2019Adverse 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 REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 650CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BRAIN FOG, CHRONIC IBS, AND FATIGUE. THE PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE AND DEVICE RUPTURE ON THE LEFT SIDE. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8615875 ↗
• InjuryMay 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 650CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BRAIN FOG, CHRONIC IBS, AND FATIGUE. THE PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE AND DEVICE RUPTURE ON THE LEFT SIDE. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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.

  Patient problems: No Code Available

  MAUDE report 8615868 ↗