MENTOR MemoryGel Breast Implant 3507680MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317004288), received between Nov 3, 2021 and Apr 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24875427 ↗
• InjuryFeb 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE FIRST OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2024-02559 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18812996 ↗
• InjuryFeb 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE SECOND OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2024-02558 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18812992 ↗
• InjuryJan 9, 2024Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 680CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL DEVICE MIGRATION WITH ASYMMETRY POST PROCEDURE. THE BREASTS WERE CROOKED, ONE WAS BIGGER THAN THE OTHER, AND THE BREASTS WERE OUT OF THE POCKET. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022. THE PATIENT HAD EVENTS WITH HER PREVIOUSLY SET OF IMPLANTS REPORTED UNDER 1645337-2021-12235 AND 1645337-2021-12177. THE LEFT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2022-03131. ON DECEMBER 19, 2023 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18480474 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 35-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 680CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 4 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: Capsular Contracture

  MAUDE report 17173390 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 680CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 4 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: Capsular Contracture

  MAUDE report 17173381 ↗
• InjurySep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 680CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITH NO REPLACEMENT ON AUGUST 23, 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15415185 ↗
• InjurySep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 680CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITH NO REPLACEMENT ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15415184 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 680CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED AT THE PHYSICIAN¿S OFFICE. AS A RESULT, UNILATERAL REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL IMPLANT WAS PERFORMED ON (B)(6) 2022. THE PATIENT HAD EVENTS WITH HER PREVIOUSLY SET OF IMPLANTS REPORTED UNDER 1645337-2021-12235 AND 1645337-2021-12177.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 13864484 ↗
• InjuryNov 3, 2021Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 680CC MENTOR MEMORYGEL BREAST IMPLANT, AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. ON OCTOBER 14, 2021, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE. UPON EXPLANT, THE LEFT SIDE DEVICE WAS FOUND TO BE SOFT AND INTACT. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH SAME 680CC SMOOTH GEL IMPLANTS ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12746843 ↗
• InjuryNov 3, 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 UNDERWENT REVISION BREAST AUGMENTATION WITH 680CC MENTOR MEMORYGEL BREAST IMPLANT, AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. ON OCTOBER 14, 2021, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE. UPON EXPLANT, THE LEFT SIDE DEVICE WAS FOUND TO BE SOFT AND INTACT. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH SAME 680CC SMOOTH GEL IMPLANTS ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12746842 ↗