MENTOR MemoryGel Breast Implant 3507510MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00081317004240), received between Jun 13, 2019 and Sep 11, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Material Rupture” (28 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 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast reconstruction revision with a 510cc MENTOR MemoryGel Breast Implant on the left breast. Post-operatively, the patient developed left breast hematoma. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement device was a Mentor gel implant.

  Patient problems: Hematoma

  MAUDE report 50733202 ↗
• InjuryMar 2, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III), BILATERAL BREAST PTOSIS, BILATERAL ENCAPSULATION, BILATERAL IMPLANT DISPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24492398 ↗
• InjuryFeb 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (RIGHT) EXPERIENCED A RUPTURE ON THE LEFT SIDE, AND SWOLLEN LYMPH NODES AND CAPSULAR CONTRACTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24419800 ↗
• InjuryNov 28, 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 BREAST AUGMENTATION REVISION WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Capsular Contracture

  MAUDE report 23674685 ↗
• InjuryNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) 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 23501117 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED IMPLANT SITE FLUID COLLECTION AND BREAST PAIN (DULL) ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. AS THIS IS NOT POSSIBLE, MENTOR ASSOCIATES REACHED OUT FOR FURTHER INFORMATION, YET MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. IF NEW INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT.

  Patient problems: Breast Discomfort/Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569687 ↗
• InjuryJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. 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: Deformity/ Disfigurement

  MAUDE report 22285490 ↗
• InjuryJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. 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: Deformity/ Disfigurement

  MAUDE report 22285489 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20263654 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20263179 ↗
• InjuryJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 510CC SILICONE PROSTHESIS EXPERIENCED BILATERAL SILENT RUPTURE POST OPERATION. THE PATIENT WENT INTO SURGERY FOR A BIGGER SET OF IMPLANTS AND DURING SURGERY THE MD/SURGEON DISCOVERED BILATERAL RUPTURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3505700BC, SERIAL NUMBER (B)(6), RIGHT CATALOG NUMBER 3505700BC, SERIAL NUMBER (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19762224 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 490CC AND 510CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19521965 ↗
• InjuryMar 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED A RIGHT BREAST THAT HAS BECOME DROOPY, SAGGY, AND FELT LIKE IT HAS LOST SOME SOLUTION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18821705 ↗
• InjuryFeb 27, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 470CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL IMPLANT DISPLACEMENT AND BREAST PTOSIS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 650CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2024. HOWEVER, DURING THE SURGERY, A RUPTURED LEFT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02400 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18791344 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE MEDICAL PROFESSIONAL. IT WAS ALSO REPORTED THAT THE RIGHT SIDE WAS OUT OF PLACE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH NON-MENTOR ALLERGAN DEVICES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18696938 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE MEDICAL PROFESSIONAL. IT WAS ALSO REPORTED THAT THE RIGHT SIDE WAS OUT OF PLACE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH NON-MENTOR ALLERGAN DEVICES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18696929 ↗
• InjuryOct 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA ULTRASOUND AND MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12203 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17940864 ↗
• InjuryOct 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 510CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA ULTRASOUND AND MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12202 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17940861 ↗
• InjurySep 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST CONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 510CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17687329 ↗
• InjuryJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 510CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE LEFT IMPLANT ALSO FOLDED. THE RUPTURE WAS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-07617 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17213870 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 510CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE LEFT IMPLANT ALSO FOLDED. THE RUPTURE WAS CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-07616 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17213869 ↗
• InjuryMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST DROPPING AND RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (RIGHT) 350CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503501BC LOT: 9636204 SN: (B)(4) AND (LEFT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503001BC LOT: 9861691 SN: (B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16857891 ↗
• InjuryDec 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15951070 ↗
• InjuryNov 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL , 510CC SILICONE BREAST IMPLANT EXPERIENCED LEFT-SIDED SILENT RUPTURE POSTOPERATIVELY. THE MATTER WAS DIAGNOSED THROUGH MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15890164 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 510CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. 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: Deformity/ Disfigurement

  MAUDE report 15601209 ↗