MENTOR MemoryGel Breast Implant 3505215BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317006879), received between Sep 1, 2021 and Feb 20, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 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 215CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES CLASSIFIED AS GRADE IV FOLLOWING IMPLANTATION. THE PATIENT PRESENTED WITH ULTRASOUND RESULTS AND REPORTED BREAST DISCOMFORT, CONFIRMING THE GRADE IV CONTRACTURE. CONSEQUENTLY, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: RIGHT SIDE WITH CATALOG NUMBER 350-5185BC/(B)(6), AND LEFT SIDE WITH CATALOG NUMBER 350-5185BC/(B)(6) ON (B)(6) 2024. THIS REPORT SPECIFICALLY RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21428510 ↗
• InjuryFeb 20, 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 215CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURES CLASSIFIED AS GRADE IV FOLLOWING IMPLANTATION. THE PATIENT PRESENTED WITH ULTRASOUND RESULTS AND REPORTED BREAST DISCOMFORT, CONFIRMING THE GRADE IV CONTRACTURE. CONSEQUENTLY, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: RIGHT SIDE WITH CATALOG NUMBER 350-5185BC/9994925-031, AND LEFT SIDE WITH CATALOG NUMBER 350-5185BC/9994925-024 ON (B)(6)2024. THIS REPORT SPECIFICALLY RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 21428484 ↗
• InjuryFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE, BREAST PAIN ON THE LEFT SIDE, AND A BREAST CYST ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s)

  MAUDE report 21365999 ↗
• MalfunctionApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT 215CC MENTOR MEMORYGEL BREAST IMPLANTS BEING USED FOR A BREAST AUGMENTATION MAMMOPLASTY PROCEDURE RUPTURED INTRAOPERATIVELY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116135 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 24-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 1-2) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 16281467 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 24-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 16029186 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 215CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15675311 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 215CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR POST PROCEDURE. SURGICAL INTERVENTION OF AN UNSPECIFIED NATURE WAS PERFORMED BILATERALLY ON AN UNSPECIFIED DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-09811 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12411189 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 215CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR POST PROCEDURE. SURGICAL INTERVENTION OF AN UNSPECIFIED NATURE WAS PERFORMED BILATERALLY ON AN UNSPECIFIED DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2021-09813 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 12411188 ↗