MENTOR MemoryGel Breast Implant 3505400BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 00081317006947), received between May 30, 2019 and Sep 29, 2026 — classified as 164 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (65 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 25 most recent of 181 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that a patient who underwent a breast reconstruction procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis developed pain in her left breast post implantation. The patient believed that the implant was ruptured and had an MRI performed. MRI results did not indicate rupture but noted that there was a ¿collection¿. As a result, the patient underwent explantation and replacement with a MENTOR MemoryGel Breast Implant gel breast prosthesis. During explant surgery, the surgeon noticed that the prosthesis was intact but had bubbles in the implant.

  Patient problems: Breast Discomfort/Pain; Fluid Discharge

  MAUDE report 50935992 ↗
• InjuryAug 3, 2026Material Rupture

  It was reported that a patient underwent a breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s right breast prosthesis was diagnosed via a physical exam. As a result, the patient underwent explantation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123352 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS 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 SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24878052 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS 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 RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24878040 ↗
• InjuryApr 8, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST PAIN AND ENCAPSULATION. THE PATIENT WAS ALSO DIAGNOSED, VIA MRI, WITH POSSIBLE RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24819930 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 30-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 400CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND A 430CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (AKER GRADE 4 ON THE LEFT AND 3 ON THE RIGHT) 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 24767626 ↗
• InjuryMar 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 24606171 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture; Impaired Healing

  MAUDE report 24418728 ↗
• MalfunctionFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURED IMPLANT OF AN UNDISCLOSED SIDE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337704 ↗
• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24315565 ↗
• InjuryDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23819264 ↗
• InjurySep 17, 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 III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23079108 ↗
• InjurySep 5, 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 IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Capsular Contracture

  MAUDE report 22980774 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 74-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 400CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3505400BC) WITH LOT NUMBER 2070761.

  Patient problems: Capsular Contracture

  MAUDE report 22868250 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES 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: Deformity/ Disfigurement

  MAUDE report 22740019 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 400CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES 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: Deformity/ Disfigurement

  MAUDE report 22740018 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 455CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22341636 ↗
• InjuryJun 24, 2025Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL SAGGING BREASTS ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22320134 ↗
• InjuryJun 17, 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 400CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, DEVICE REPLACEMENT WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 22248372 ↗
• InjuryJun 17, 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 400 CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, DEVICE REPLACEMENT WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 22248323 ↗
• InjuryMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22091744 ↗
• MalfunctionMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT RUPTURE OF TWO (2) MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES WAS OBSERVED DURING A SCHEDULED BREAST AUGMENTATION PROCEDURE. WHEN ONE OF THE DEVICES WAS INTRODUCED, RUPTURE WAS NOTED ON THE DEVICE. THE SURGEON FELT BOTH OF THE BREAST PROSTHESES THAT WERE TO BE USED FOR THE SURGERY AND NOTICED THAT THEY FELT THINNER THAN OTHER BREAST PROSTHESES. AS A RESULT, THE PROCEDURE WAS COMPLETED WITH TWO DIFFERENT MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048940 ↗
• MalfunctionMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT RUPTURE OF TWO (2) MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES WAS OBSERVED DURING A SCHEDULED BREAST AUGMENTATION PROCEDURE. WHEN ONE OF THE DEVICES WAS INTRODUCED, RUPTURE WAS NOTED ON THE DEVICE. THE SURGEON FELT BOTH OF THE BREAST PROSTHESES THAT WERE TO BE USED FOR THE SURGERY AND NOTICED THAT THEY FELT THINNER THAN OTHER BREAST PROSTHESES. AS A RESULT, THE PROCEDURE WAS COMPLETED WITH TWO DIFFERENT MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048939 ↗
• InjuryMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22043167 ↗
• InjuryMay 19, 2025Adverse 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 400CC AND EXPERIENCED SUSPECTED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. UPON EXPLANTATION, THE DEVICE WAS FOUND TO BE INTACT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22043076 ↗