MENTOR MemoryGel Breast Implant 3541507Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317000617), received between Dec 22, 2018 and Oct 17, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 150CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 175CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. 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 1645337-2023-12210 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17950781 ↗
• InjuryAug 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, AN EXPLANT IS SCHEDULED FOR (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15188852 ↗
• InjuryMay 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH AN MENTOR MEMORYGEL, 150CC BREAST IMPLANT EXPERIENCED RIGHT SIDED SILENT RUPTURE POSTOPERATIVELY. THE CT SCAN CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED MENTOR SILICONE IMPLANTS ON (B)(6) 2022. THIS IS RELATED TO ADJUNCT STUDY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14496337 ↗
• InjuryAug 18, 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 PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS DEVELOPED A LUMP IN THE LOWER PART OF HER RIGHT BREAST. THE LUMP HAS GOTTEN LARGER OVER TIME. THE LUMP HAS BEEN ASSESSED BY A HEALTHCARE PROFESSIONAL AND IT WAS DETERMINED THAT IT IS NON-MALIGNANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 12339850 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 150CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST, SUFFERED BREAST ASYMMETRY AND FIRMNESS, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9837495 ↗
• InjuryOct 10, 2019Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE, DEVICE MIGRATION AND GRANULOMA POST-OPERATIVELY. THE RUPTURES WERE CONFIRMED WITH AN MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Granuloma; No Code Available

  MAUDE report 9176039 ↗
• InjuryOct 10, 2019Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 150CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE, DEVICE MIGRATION AND GRANULOMA POST-OPERATIVELY. THE RUPTURES WERE CONFIRMED WITH AN MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Granuloma; No Code Available

  MAUDE report 9175813 ↗
• InjuryDec 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED SIENTRA BREAST IMPLANTS ON (B)(6) 2018. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 8206174 ↗
• InjuryDec 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 150CC AND EXPERIENCED BILATERAL RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED SIENTRA BREAST IMPLANTS ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 8206173 ↗
• InjuryDec 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE RIGHT BREAST PROSTHESIS WAS CONFIRMED BY MRI. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8193010 ↗