MENTOR MemoryGel Breast Implant 3545350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317007128), received between Nov 22, 2021 and Nov 6, 2025 — classified as 2 injuries, 4 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS WAS NOTED TO BE RUPTURED DURING A PRIMARY BREAST RECONSTRUCTION SURGERY AFTER BEING PLACED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT HARMS/CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493243 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22852573 ↗
• MalfunctionOct 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 350CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED BREAST RUPTURE INTRAOPERATIVELY. THE REPORT INDICATED THAT DURING PLACEMENT OF THE IMPLANT INSIDE THE POCKET, BROKE COMPLETELY. NO ADVERSE EVENT, NOR ANY PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17933105 ↗
• MalfunctionSep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A A 350CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED DURING A BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790272 ↗
• InjuryJun 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST PAIN. DURING A PHYSICAL EXAM, SHE WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023. HOWEVER, DURING THE SURGERY, A RUPTURED RIGHT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY.

  Patient problems: Capsular Contracture

  MAUDE report 17143721 ↗
• MalfunctionNov 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED FOR A PRIMARY BREAST AUGMENTATION RUPTURED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE REPLACEMENT DEVICE, 350CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT CATALOG #: 3544350, LEFT SERIAL #: (B)(4)). NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED. AT THE TIME OF THIS REPORT, THERE IS NO EVIDENCE OF A NEED FOR ADDITIONAL SURGICAL INTERVENTION, BUT A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12855183 ↗