MENTOR MemoryGel Breast Implant 3505650BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 00081317007005), received between May 11, 2019 and Sep 28, 2026 — classified as 200 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (92 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 203 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926504 ↗
• InjurySep 14, 2026Material Rupture

  It was reported that a patient underwent a Breast Surgery with implantation of a 650cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient underwent left-sided exchange with a Mentor gel implant on August 13, 2026, for an undisclosed reason. However, after the surgery, the explanted device was observed ruptured. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754417 ↗
• InjuryMay 26, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT, AND SUBSEQUENTLY DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING COMPUTERIZED TOMOGRAPHY IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283430 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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: Capsular Contracture

  MAUDE report 24988568 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED THE FOLLOWING SYMPTOMS, ROCK HARD BREASTS, PAIN, FATIGUE, DRY MOUTH, AND UNSPECIFIED AUTOIMMUNE DISEASE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 24981747 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED THE FOLLOWING SYMPTOMS, ROCK HARD BREASTS, PAIN, FATIGUE, DRY MOUTH, AND UNSPECIFIED AUTOIMMUNE DISEASE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 24981624 ↗
• InjuryFeb 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24445588 ↗
• InjuryJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977319 ↗
• InjuryDec 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED RIGHT IMPLANT. ULTRASOUND IMAGING WAS CONDUCTED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23791194 ↗
• InjuryDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 685CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23735386 ↗
• InjuryDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 685CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23735385 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4 ON THE LEFT AND BAKER GRADE 2 ON THE RIGHT) AND BILATERAL BREAST PTOSIS POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23067423 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4 ON THE LEFT AND BAKER GRADE 2 ON THE RIGHT) AND BILATERAL BREAST PTOSIS POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) , 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23067421 ↗
• InjuryAug 21, 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22867070 ↗
• MalfunctionAug 20, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BREAST IMPLANT APPEARED TO DISPLAY A BROKEN PACKAGING SEAL PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851036 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3506004BC).

  Patient problems: Capsular Contracture

  MAUDE report 22819403 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 650CC SILICONE BREAST IMPLANT HAS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV AND LEFT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POSTOPERATIVELY. THE MATTER WAS DIAGNOSED THROUGH OFFICE VISITATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: SN: L (B)(6) // R: (B)(6), RIGHT SIDED CAPSULECTOMY AND BILATERAL; CAPSULORRHAPHY ON (B)(6) 2025. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 22815728 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION AND CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22667850 ↗
• InjuryJul 30, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION AND CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22667849 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT AN ELECTIVE REVISION SURGERY ON (B)(6) 2025. HOWEVER, DURING THE SURGERY, A RUPTURED RIGHT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE FINDINGS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22500545 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST RIPPLING, DIMPLING, BREAST PAIN, AND RIGHT BURNING SENSATION THAT RADIATED TO THE NIPPLE. THE PATIENT WAS ALSO DIAGNOSED VIA MRI, WITH LEFT BREAST CYST AND LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE: (LEFT) 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB685 LOT: 2021680 SN: (B)(6) AND (RIGHT) 685CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB685 LOT: 2013908 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Wrinkling

  MAUDE report 22433952 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED NEEDLE BIOPSY OF THE LEFT BREAST FOR AN UNDISCLOSED REASON. INCIDENTALLY, THE LEFT BREAST IMPLANT WAS RUPTURED DURING THE PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 280CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21977615 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21701347 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL, 650CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVELY. CONSEQUENTLY, THE PATIENT UNDERWENT A RIGHT-SIDED CAPSULECTOMY ALONG WITH BILATERAL REPLACEMENTS. THE NEW IMPLANTS UTILIZED WERE AS FOLLOWS: LEFT CATALOG NUMBER SHPX490 WITH SERIAL NUMBER (B)(6), AND RIGHT CATALOG NUMBER SHPX490 WITH SERIAL NUMBER (B)(6), BOTH PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21699306 ↗
• InjuryMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21646178 ↗