MENTOR MemoryGel Breast Implant 3505700BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00081317007012), received between May 3, 2019 and Sep 23, 2026 — classified as 124 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (56 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 126 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent Breast Reconstruction Revision with MENTOR MemoryGel, 650cc on left, 700cc on the right Silicone prosthesis. subsequently the patient experienced bilateral capsular contracture grade III postoperatively. The issue was diagnosed through physical examinations. As a result, the patient underwent bilateral replacements per following: L/ SN: (b)(6), R/ SN: (b)(6) on (b)(6) 2026. This report relates to the right side.

  Patient problems: Capsular Contracture

  MAUDE report 50871418 ↗
• InjurySep 22, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 700cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026, for an undisclosed reason. However, during the surgery, a ruptured right implant was discovered. There were no reported procedural delays or patient consequences/harms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856546 ↗
• InjurySep 2, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567131 ↗
• InjurySep 2, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567130 ↗
• InjurySep 2, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566845 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION (BAKER GRADE III IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. 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: Capsular Contracture

  MAUDE report 24889442 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A RUPTURED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24749474 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A RUPTURED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24749473 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24747363 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24747362 ↗
• InjuryDec 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23933894 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST PTOSIS, BILATERAL BREAST PAIN, AND SWELLING IN THE LEFT BREAST. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 23900953 ↗
• InjuryDec 26, 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 PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST PTOSIS, BILATERAL BREAST PAIN, AND SWELLING IN THE LEFT BREAST. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Local Reaction

  MAUDE report 23900950 ↗
• InjuryNov 10, 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 SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23512815 ↗
• InjuryNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 790CC HIGH PROFILE SILICONE XTRA GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23498612 ↗
• InjurySep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE RUPTURE WAS ALLEGED TO HAVE OCCURRED FOLLOWING A ROUTINE SONOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23019185 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED ASYMMETRY 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: Deformity/ Disfigurement

  MAUDE report 22885225 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22666386 ↗
• InjuryApr 17, 2025Gel Leak; Adverse Event Without Identified Device or Use Problem; Gel Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 700CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING RASHES, HAIR LOSS, SHOOTING PAINS, SWELLING, AND INFLAMMATION. RUPTURE ON THE RIGHT SIDE WAS ALSO REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 21862055 ↗
• InjuryApr 17, 2025Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 700CC AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING RASHES, HAIR LOSS, SHOOTING PAINS, SWELLING, AND INFLAMMATION. RUPTURE ON THE RIGHT SIDE WAS ALSO REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 21861119 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL 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 21638579 ↗
• InjuryJan 29, 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 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE REPORTED ISSUES WERE NOTICED FOLLOWING A CAR ACCIDENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21265826 ↗
• InjuryJan 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE REPORTED ISSUES WERE NOTICED FOLLOWING A CAR ACCIDENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21265802 ↗
• InjuryJan 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED RIGHT BREAST IMPLANT. MAGNETIC RESONANCE IMAGING WAS CONDUCTED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21255291 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 30-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20852716 ↗