MENTOR MemoryGel Breast Implant 3507001BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00081317000372), received between Feb 1, 2018 and Sep 11, 2026 — classified as 242 injuries.

The most frequently reported specific device problem is “Material Rupture” (145 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 242 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed via mammogram. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the left breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735818 ↗
• InjuryAug 7, 2026Migration

  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 a ruptured left implant Magnetic Resonance Imaging and bilateral implant malposition during a physical exam. 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: Deformity/ Disfigurement

  MAUDE report 50175047 ↗
• InjuryJul 27, 2026Material Rupture

  It was reported that a patient implanted with two MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50040738 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT ULTRASOUND WITH ASPIRATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24693291 ↗
• InjuryMar 10, 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 UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026, FOR AN UNDISCLOSED REASON. A RUPTURED LEFT IMPLANT WAS REPORTED POST-REPLACEMENT. 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

  MAUDE report 24563377 ↗
• InjuryFeb 27, 2026Adverse 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 24475921 ↗
• InjuryFeb 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24373419 ↗
• InjuryFeb 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED POST IMPLANTATION. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24373417 ↗
• InjuryFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND RIPPLING 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: Wrinkling

  MAUDE report 24264835 ↗
• InjuryJan 14, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24072252 ↗
• InjuryDec 2, 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 RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BREAST PAIN AND RESULTANTLY, DIAGNOSTIC IMAGING WAS PERFORMED WHICH IDENTIFIED MICRO CALCIFICATIONS IN THE LEFT BREAST. SHE WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE II CAPSULAR CONTRACTURE AND A NODULE IN THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025. DURING THE SURGERY, THE SURGEON HAD DIFFICULTY REMOVING THE LEFT IMPLANT AS IT WAS STUCK TO THE CHEST WALL. ADDITIONALLY, THE RIGHT IMPLANT WAS NOTED TO HAVE A DENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Autoimmune Disorder; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23700543 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC 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 23597457 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23381339 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23381332 ↗
• InjurySep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 700CC 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23086479 ↗
• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND AND MRI, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22982653 ↗
• InjuryAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2017, AND REPLACED WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3507501BC) WITH LOT NUMBER 7001166.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22905262 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

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

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22666448 ↗
• InjuryJul 21, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse 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 REPORTED EXPERIENCING A REDUCTION IN BREAST VOLUME WITH FIRM AND HARD BREASTS. ULTRASOUND, MAMMOGRAM, AND MAGNETIC RESONANCE IMAGING WAS PERFORMED; HOWEVER A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS NOT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22561057 ↗
• InjuryJul 10, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV) AND IMPLANT DISPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22465856 ↗
• InjuryMay 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 85-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22119853 ↗
• InjuryMay 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BREAST PAIN AND RUPTURE 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: Breast Discomfort/Pain

  MAUDE report 22020367 ↗
• InjuryMay 14, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22019618 ↗
• InjuryMay 5, 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 CAPSULAR CONTRACTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21963056 ↗
• InjuryApr 2, 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 RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED DEVELOPED RIGHT BREAST INVASIVE DUCTAL CARCINOMA, GRADE 2 (CT1CN0). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND BILATERAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS ON (B)(6) 2025. IT WAS ALSO REPORTED THAT, DURING SURGERY, THE LEFT IMPLANT WAS FOUND TO BE RUPTURED. IT WAS ALSO REPORTED THAT THE PATIENT HAD HISTORY OF 3 ADDITIONAL SURGERIES DUE TO CAPSULAR CONTRACTURE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Cancer; Capsular Contracture

  MAUDE report 21752859 ↗