MENTOR MemoryShape Breast Implant 3341204Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317024224), received between Jun 23, 2021 and Mar 17, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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.

• InjuryMar 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR GEL IMPLANT (RIGHT) AND A 430CC MENTOR MEMORYSHAPE BREAST IMPLANT (LEFT) EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE DISCOVERED DURING EXPLANT. AS A RESULT, REPLACEMENT WITH MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21617859 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (B)(4):. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION PRIMARY SURGERY WITH 485CC MENTOR MEMORYSHAPE BREAST IMPLANT MENTOR GLOW STUDY GEL DEVICE ON (B)(6) 2020. ADVERSE EVENT # 1. INFECTION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2022; DATE OF EXPLANT: (B)(6) 2022). ON (B)(6) 2022, SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL, AND REPLACEMENT ON (B)(6) 2022. ADVERSE EVENT # 2. HEMATOMA, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6)2022). SURGERY WITH 430CC MENTOR MEMORYSHAPE BREAST IMPLANT MENTOR GLOW STUDY GEL DEVICE ON (B)(6) 2022. ON (B)(6) 2022, SHE PRESENTED WITH HEMATOMA, WHICH REQUIRED EVACUATION OF RIGHT BREAST HEMATOMA ON (B)(6) 2022. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE ADVERSE EVENT #2.

  Patient problems: Cancer; Hematoma; Post Operative Wound Infection; Seroma

  MAUDE report 15800006 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 430CC MENTOR MEMORY SHAPE BREAST IMPLANTS AND EXPERIENCED PERSISTENT SLEEP DISORDERS ON POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 15567851 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 430CC MENTOR MEMORY SHAPE BREAST IMPLANTS AND EXPERIENCED PERSISTENT SLEEP DISORDERS ON POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 15567138 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 485CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15175784 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT AND A 430CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED ASYMMETRIC APPEARANCE WITH BOTH IMPLANTS POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2020. THIS PATIENT WAS IN A CLINICAL STUDY. SEE 1645337-2021-07157 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12054528 ↗