MENTOR MemoryGel Breast Implant 3507504BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00081317003878), received between May 24, 2018 and Sep 8, 2026 — classified as 192 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (94 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 194 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Material Rupture

  It was reported that a 34-year-old Caucasian female patient underwent revision breast augmentation with 750cc MENTOR MemoryGel Breast Implant on the left side, and with 800cc MENTOR MemoryGel Breast Implant on the right side and experienced bilateral breast implant ruptures postoperatively; diagnosed in the office and via ultrasound. The patient has consulted with the healthcare professional. As a result, the devices were explanted on (b)(6) 2026.This MedWatch report is for the patient¿s left-sided device.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ptosis

  MAUDE report 50671105 ↗
• InjuryJun 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25476600 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A VGEL BREAST PROSTHESIS SUFFERED FROM SWELLING OF THE LEFT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 24879195 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN 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: Breast Discomfort/Pain

  MAUDE report 24861088 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24861054 ↗
• InjuryApr 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE II (LEFT BREAST) AND III (RIGHT BREAST) BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. FURTHERMORE, DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED WHICH RESULTED IN A 30-MINUTE DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES/HARMS DUE TO THE FINDING. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24834449 ↗
• MalfunctionApr 9, 2026No Apparent Adverse Event

  A 750 CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 24831553 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL DEVICE EXTRUSION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pocket Erosion

  MAUDE report 24705803 ↗
• InjuryMar 26, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND DEVICE MIGRATION 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24705067 ↗
• InjuryMar 7, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE AND LYMPH NODE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 24540428 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 750CC 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 EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24524956 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, MAMMOGRAM RESULTS INDICATED BENIGN TYPE BREAST CALCIFICATIONS BILATERALLY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES ON (B)(6) 2025. DURING EXPLANT SURGERY, IT WAS NOTED THAT THE RIGHT BREAST PROSTHESIS WAS FOLDED OVER. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-12407 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24382180 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A VIRTUAL EXAM AS THE PATIENT EXPERIENCED A FIRM, HARD, AND HIGH RIDING LEFT IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24215931 ↗
• InjuryJan 15, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING MAMMOGRAM AND MAGNETIC RESONANCE 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: Deformity/ Disfigurement

  MAUDE report 24084663 ↗
• InjuryJan 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT WITH A DEPLOYED AIR BAG AND DEVELOPED IRREGULAR SHAPED BREASTS, BREAST PAIN, AND BURNING SENSATION. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Crushing Injury; Deformity/ Disfigurement; Paresthesia

  MAUDE report 24060616 ↗
• InjuryJan 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT WITH A DEPLOYED AIR BAG AND DEVELOPED IRREGULAR SHAPED BREASTS, BREAST PAIN, AND BURNING SENSATION. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Crushing Injury; Deformity/ Disfigurement; Paresthesia

  MAUDE report 24060614 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH SIENTRA (NON-MENTOR) IMPLANTS ON (B)(6) 2025, FOR A SIZE EXCHANGE AND PTOSIS. HOWEVER, DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PATIENT HARMS, CONSEQUENCES, OR PROCEDURAL DELAYS DUE TO THE FINDING.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23658708 ↗
• InjuryNov 24, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 750CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD CONCERNS OF FEELING THE LEFT IMPLANT. DURING A PHYSICAL EXAM, THE EXAMINER STATED THE LEFT IMPLANT WAS FLIPPED AND THE AREA OF CONCERN WAS POSSIBLY THE FILL PORT OF THE IMPLANT. THE PATIENT WANTED TO INQUIRE AS SHE DOESN'T BELIEVE HER IMPLANT HAS A FILL PORT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23639290 ↗
• InjuryNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 750CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA 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; Deformity/ Disfigurement

  MAUDE report 23612748 ↗
• InjuryNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A CT SCAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23610432 ↗
• InjuryNov 19, 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 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A MALIGNANT NEOPLASM AND A BREAST CYST ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Breast Cancer; Cyst(s)

  MAUDE report 23597682 ↗
• InjuryNov 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 23533404 ↗
• InjurySep 17, 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 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23073854 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN. THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22401327 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN. THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22401326 ↗