MENTOR MemoryGel Breast Implant 3544707MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317004479), received between Oct 24, 2019 and Jul 8, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 470CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED OBSERVED ROUND BALLS AROUND HER ARMPIT AND THE SIDE OF HER RIGHT BREAST. ULTRASOUND WAS PERFORMED AND CONFIRMED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. 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.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 19697047 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 470CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18803599 ↗
• InjuryMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 470CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING MAGNETIC RESONANCE IMAGING. 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 1645337-2023-02525 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 16492316 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 470CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE II CAPSULAR CONTRACTURE OF THE LEFT BREAST DURING AN IN-PERSON VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16452973 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WHITE HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A 470CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST, HAD TO UNDERGONE REMOVAL AND REPLACEMENT BECAUSE THE IMPLANT WAS TOO BIG, POST-PROCEDURE. IT WAS REPORTED TO BE DUE TO INCORRECT INFORMATION REGARDING THE SIZE. THE REVISION SURGERY WAS ON (B)(6) 2016 AND THE REPLACEMENT DEVICE WAS A 445CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3544457MC, LOT: 7282478, SN: (B)(4)).

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

  MAUDE report 12523888 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A REVISION BREAST RECONSTRUCTION WITH A 470CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND A 275CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) EXPERIENCED POSTOPERATIVE RIGHT-SIDED CAPSULAR CONTRACTURE ( GRADE UNKNOWN) AND TIREDNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT PROSTHESIS. MANUFACTURER REPORT NUMBER FOR CONTRALATERAL SIDE: 1645337-2019-22302.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9235841 ↗