MENTOR MemoryGel Breast Implant 3545107MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317004493), received between Apr 7, 2021 and Feb 19, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Granuloma

  MAUDE report 24389977 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 510CC 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 23648784 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 510CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED POSSIBLE BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA COMPUTERIZED TOMOGRAPHY SCAN. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04758 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16797779 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED NEEDLE LIKE PAIN IN BOTH BREASTS, HEAT SENSATION, AND ENLARGEMENT THAT IS GOING UP AND VERY NOTICEABLE. 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: Capsular Contracture; Paresthesia

  MAUDE report 14806956 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED NEEDLE LIKE PAIN IN BOTH BREASTS, HEAT SENSATION, AND ENLARGEMENT THAT IS GOING UP AND VERY NOTICEABLE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 14806913 ↗
• InjuryApr 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS (445CC ON THE LEFT AND 510CC ON THE RIGHT) EXPERIENCED BILATERAL IMPLANT RUPTURE POSTOPERATIVELY. RUPTURE WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS, 590CC ON THE LEFT ( LEFT CATALOG # 3505590BC AND LOT-SERIAL # (B)(4)) AND 535CC ON THE RIGHT (RIGHT CATALOG # 3505535BC AND LOT-SERIAL # (B)(4)) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11713595 ↗
• InjuryApr 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND DISCOMFORT ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3505001BC; SERIAL NUMBER (B)(4) ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11628506 ↗