MENTOR MemoryGel Breast Implant 3505800BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00081317007036), received between May 14, 2019 and Sep 28, 2026 — classified as 157 injuries.

The most frequently reported specific device problem is “Material Rupture” (51 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 157 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  It was reported that a patient underwent a Breast Reconstruction Revision Surgery with implantation of an 800cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with a ruptured right implant by a medical professional. As a result, the patient underwent bilateral implant removal without replacements on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916334 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT PRESENTED FOR A PHYSICAL EXAM AND STATED SHE HAD DEVELOPED A LEFT BREAST HEMATOMA FOLLOWING THE IMPLANT SURGERY WITH THE SUSPECT DEVICE WHICH SHE BELIEVES RELATED TO THE DEVELOPMENT OF THE LEFT BREAST CAPSULAR CONTRACTURE. SHE WAS THEN EVALUATED AND DIAGNOSED WITH BAKER GRADE III (LEFT BREAST) AND II (RIGHT BREAST - SOFT CAPSULE) CAPSULAR CONTRACTURE. THE HEMATOMA HAD RESOLVED BY THE TIME OF THE PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026. THERE WAS NO INTERVENTION PERFORMED ON THE RIGHT SIDE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25488638 ↗
• InjuryApr 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED ASYMMETRY ON THE LEFT SIDE AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25001618 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2-3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24748956 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2-3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24748946 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST ITCHING, CONICAL SHAPED BREAST, LEFT IMPLANT RUPTURE, AND BILATERAL BREAST IMPLANTS MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT. FOR THE RIGHT IMPLANT, 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: Deformity/ Disfigurement

  MAUDE report 24723783 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CYST AND DEVICE EXPOSURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Cyst(s); Pocket Erosion

  MAUDE report 24693178 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BREAST CYST AND DEVICE EXTRUSION 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: Cyst(s); Pocket Erosion

  MAUDE report 24664006 ↗
• InjuryMar 2, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE 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) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24488668 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A SMOOTH 1240CC MENTOR GEL IMPLANT EXPERIENCED LEFT SIDED RUPTURE AND RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THE RIGHT BREAST WAS TIGHTENED. THE RUPTURE WAS DETECTED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT AND REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE LEFT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2025-11793. ON FEBRUARY 3, 2025. I RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24443103 ↗
• InjuryFeb 17, 2026Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24372100 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24326671 ↗
• InjuryFeb 5, 2026Migration

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT A BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT MENTIONED THAT THE BREAST PROSTHESIS WERE FALLING UNDER THE ARMPIT AS WELL AS THE DESCRIBING THE PROSTHESES AS SOFT AND HARD. 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 24273655 ↗
• InjuryFeb 5, 2026Migration

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT A BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT MENTIONED THAT THE BREAST PROSTHESIS WERE FALLING UNDER THE ARMPIT AS WELL AS THE DESCRIBING THE PROSTHESES AS SOFT AND HARD. 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 24273647 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24210712 ↗
• InjuryDec 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. THE PATIENT HAD TRAUMA TO THE PECTORAL MUSCLE THAT IS CAUSING MUSCLE SPASM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) , 2026.

  Patient problems: Breast Discomfort/Pain; Crushing Injury

  MAUDE report 23938584 ↗
• InjuryNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23524131 ↗
• InjurySep 16, 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 LEFT 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 23067915 ↗
• InjurySep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23012102 ↗
• InjuryAug 27, 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 SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 22908860 ↗
• InjuryAug 27, 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 SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 22908859 ↗
• InjuryAug 8, 2025Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. MRI RESULTS INDICATED RIGHT BREAST PROSTHESIS RUPTURE AND SHOWED BUBBLES IN THE LEFT BREAST PROSTHESIS. THE DOCTOR WANTED TO GET THE MRI RESULTS REVIEWED FOR ¿MICRO RUPTURE¿ IN THE LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6) 2025 . THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22766242 ↗
• InjuryJul 31, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 800CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED SILENT RUPTURE POSTOPERATIVE. THE MAMMOGRAM EXAMINATION CONFIRMED THE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH R) REF: 3505800BC SN: (B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22682594 ↗
• InjuryMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT ELECTED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2025. DURING THE SURGERY, THE IMPLANTS WERE BOTH IDENTIFIED TO BE RUPTURED. SUBSEQUENTLY, THEY WERE REPLACED WITH TWO NON-MENTOR IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22115806 ↗
• InjuryMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT ELECTED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2025. DURING THE SURGERY, THE IMPLANTS WERE BOTH IDENTIFIED TO BE RUPTURED. SUBSEQUENTLY, THEY WERE REPLACED WITH TWO NON-MENTOR IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22115804 ↗