MENTOR MemoryGel Breast Implant 3544175Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317000990), received between Jun 16, 2021 and Nov 15, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 175CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18141845 ↗
• InjuryMay 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 175CC MENTOR MEMORYGEL BREAST IMPLANT IMPLANT AND EXPERIENCED UNKNOWN SIDE RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16875456 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 175CC MENTOR MEMORYGEL, BREAST IMPLANT ON THE RIGHT SIDE, AND 200CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY AFTER CONSULTATION WITH A MEDICAL PROFESSIONAL. MAMMOGRAM WAS TAKEN HOWEVER, UNSURE IF THE RESULTS CONFIRMED THE DIAGNOSIS. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 13501960 ↗
• InjuryJun 16, 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'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A (LEFT) 175CC MENTOR MEMORYGEL BREAST IMPLANT AND A (RIGHT) 250CC MENTOR MEMORYGEL BREAST IMPLANT, SUFFERED POSSIBLE RIGHT BREAST IMPLANT RUPTURE, BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE I ON THE LEFT), BREAST PAINT AND ROTATING IMPLANT, POST-PROCEDURE. THE COMPLICATIONS WERE DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION AND POSSIBLE REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 12014165 ↗