MENTOR MemoryGel Breast Implant 3541257Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317000600), received between Jul 27, 2020 and Jul 2, 2021 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 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 CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION PRIMARY WITH 125CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVELY. THE PATIENT HAD CAR ACCIDENT FEW YEARS AGO AND SUSPECTED RIGHT-SIDE RUPTURE. THE RIGHT IMPLANT WAS INTACT AT POST-OPERATIVE. THE CAPSULAR CONTRACTURE WAS CONFIRMED WITH A PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT / 3501254BC, SN#: (B)(4), AND RIGHT/ 3501254BC SN#: (B)(4) ON (B)(6) 2021.

  Patient problems: Capsular Contracture; Crushing Injury

  MAUDE report 12109111 ↗
• InjuryOct 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 125CC SILICONE PROSTHESIS EXPERIENCED BILATERAL RUPTURE, AND RIGHT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. MAMMOGRAM AND ULTRASOUND EXAMINATIONS TAKEN ON (B)(6) 2020 CONFIRMED THE ISSUES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT BELONG TO RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10705567 ↗
• InjuryOct 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL 125CC SILICONE PROSTHESIS EXPERIENCED BILATERAL RUPTURE, AND RIGHT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. MAMMOGRAM AND ULTRASOUND EXAMINATIONS TAKEN ON (B)(6) 2020 CONFIRMED THE ISSUES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT BELONG TO LEFT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 10705557 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. IN ADDITION, THE PATIENT DEVELOPED BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 125CC GEL BREAST PROSTHESIS ON (B)(6) 2020. THE LEFT BREAST PROSTHESIS WAS DISCARDED AFTER EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Mass; No Code Available

  MAUDE report 10330182 ↗