MENTOR MemoryGel Breast Implant 3544225Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317001010), received between Sep 25, 2019 and Sep 10, 2026 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with a 225cc MENTOR MemoryGel Breast Implant on the right breast. Post-operatively, the patient developed right breast pain and capsular contracture (baker grade IV). As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement device was a Mentor gel implant.

  Patient problems: Capsular Contracture

  MAUDE report 50708443 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Capsular Contracture

  MAUDE report 22588163 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21663271 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21663265 ↗
• InjuryDec 20, 2024Adverse 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 SURGERY WITH IMPLANTATION OF A 225CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST PAIN, HARDNESS, AND DEFORMITY. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. ADDITIONALLY, ULTRASOUND IMAGING INDICATED A RIGHT BREAST RETRO-AREOLAR CYST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 300CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Cyst(s)

  MAUDE report 20993648 ↗
• InjuryAug 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL, 225CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED SILENT RUPTURE POSTOPERATIVE. THE RUPTURE DISCOVERED BY MRI , AND MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT AN EXPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15204138 ↗
• InjuryApr 1, 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 AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC SALINE BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED BREAST IMPLANT ILLNESS SYMPTOMS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

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

  MAUDE report 13972140 ↗
• InjuryApr 1, 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 AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 225CC SALINE BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED BREAST IMPLANT ILLNESS SYMPTOMS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

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

  MAUDE report 13972139 ↗
• InjuryDec 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND RIPPLING ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 13054784 ↗
• InjuryJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 225CC AND SUFFERED FROM A LYMPHADENOPATHY ON THE RIGHT SIDE AND A BILATERAL RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 11197334 ↗
• InjuryJan 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 225CC AND SUFFERED FROM A LYMPHADENOPATHY ON THE RIGHT SIDE AND A BILATERAL RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11197289 ↗
• InjuryDec 21, 2020Adverse 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 A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POSTOPERATIVELY (LEFT GRADE : III, RIGHT GRADE: IV) . THE PATIENT IS EXPERIENCING BILATERAL BREAST PAIN. THE DIAGNOSIS WAS CONFIRMED BASED ON THE PATIENT¿S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDED PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11052598 ↗
• InjuryDec 21, 2020Adverse 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 A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POSTOPERATIVELY (LEFT GRADE : III, RIGHT GRADE: IV) . THE PATIENT IS EXPERIENCING BILATERAL BREAST PAIN. THE DIAGNOSIS WAS CONFIRMED BASED ON THE PATIENT¿S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDED PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11052486 ↗
• InjurySep 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9119328 ↗