MENTOR MemoryGel Breast Implant 3507490MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00081317004233), received between May 22, 2019 and Sep 11, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (20 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 42 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 capsular contracture Baker Grade III-IV along with bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50735414 ↗
• InjuryMay 19, 2026Migration

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 490CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND A 510CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3), BREAST PTOSIS, AND SWELLING ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL DEVICE MIGRATION; THE RIGHT HAD LOWER POLE STRETCH AND SOME INFERIOR IMPLANT MALPOSITION AND THE LEFT WAS PALPABLE MEDIALLY WITH MILD MIDLINE MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 490CC MENTOR BREAST PROSTHESIS. THE LEFT SIDE BREAST PROSTHESIS WAS NOT REPLACED. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 25223715 ↗
• InjuryJan 29, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 490CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026, FOR AN UNDISCLOSED REASON. BILATERALLY RUPTURED IMPLANTS WERE REPORTED. 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24218057 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING NUMBNESS, AUTOIMMUNE ISSUES, AND ABDOMINAL PAIN. BILATERAL RUPTURE WAS ALSO REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23383347 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING NUMBNESS, AUTOIMMUNE ISSUES, AND ABDOMINAL PAIN. BILATERAL RUPTURE WAS ALSO REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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

  MAUDE report 23383346 ↗
• InjuryMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 490CC 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; Local Reaction

  MAUDE report 22062105 ↗
• InjuryJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 510CC ON THE LEFT, AND 490CC ON THE RIGHT SIDE, 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 JUNE 22, 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19762290 ↗
• InjuryJul 10, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 490CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19714189 ↗
• 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 19521991 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL , 490CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. THE CT SCAN DIAGNOSED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3505750BC, SERIAL NUMBER (B)(6), RIGHT CATALOG 3507510MC, SERIAL NUMBER (B)(6) ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19367075 ↗
• InjuryApr 30, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 490CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. DURING THE REMOVAL SURGERY, THE RIGHT BREAST IMPLANT WAS IDENTIFIED TO BE RUPTURED. SUBSEQUENTLY, THE IMPLANT WAS REPLACED WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3507490MC LOT: 9907673 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19215796 ↗
• InjuryFeb 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 490CC SILICONE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV, RIGHT SIDED SYMPTOMATIC RUPTURE, AND LEFT-SIDED GEL BLEED POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL TOTAL CAPSULECTOMIES, BILATERAL REMOVAL WITHOUT REPLACEMENT, AND LIPOSUCTION OF LATERAL CHEST ON (B)(6)2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 18628151 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 490CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024. SEE 1645337-2023-14283 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18268050 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 490CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR APRIL 11, 2024. SEE 1645337-2023-14284 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 18268042 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT'S LEFT BREAST DID NOT FEEL RIGHT OR NOT AS IT SHOULD BE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 17552924 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 490CC MENTOR MEMORYGEL LEFT BREAST IMPLANT AND A 510CC MENTOR MEMORYGEL RIGHT BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15375300 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 490CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DISCOVERED DURING EXPLANTATION SURGERY ON (B)(6) 2022. THE PATIENT DID NOT REPLACE THE REMOVED BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14681083 ↗
• InjuryJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL BREAST IMPLANT 490CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DISCOVERED DURING EXPLANTATION SURGERY ON (B)(6) 2022. THE PATIENT DID NOT REPLACE THE REMOVED BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14680943 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 490CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT BELIEVES THERE IS AN ISSUE WITH HER IMPLANTS BASED OFF HOW HER BREASTS APPEAR. 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: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 14575002 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 490CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT BELIEVES THERE IS AN ISSUE WITH HER IMPLANTS BASED OFF HOW HER BREASTS APPEAR. 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 LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 14574989 ↗
• InjuryMar 19, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 13826284 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS ON THE LATERAL SIDE WALL. AS A RESULT, BILATERAL CAPSULECTOMY AND EXPLANT WITHOUT REPLACEMENT WAS PERFORMED ON (B)(6) 2021. THE PATIENT IS FULLY RECOVERED. SEE 1645337-2022-00683 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 13322508 ↗
• InjuryJan 21, 2022Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS ON THE LATERAL SIDE WALL. AS A RESULT, BILATERAL CAPSULECTOMY AND EXPLANT WITHOUT REPLACEMENT WAS PERFORMED ON (B)(6) 2021. THE PATIENT IS FULLY RECOVERED. SEE 1645337-2022-00684 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 13322506 ↗
• InjuryDec 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 490CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13012581 ↗
• InjuryNov 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (LEFT: 490CC, RIGHT: 510CC) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (UNKNOWN GRADE) AND RUPTURE POSTOPERATIVELY. DUE TO THE BILATERAL CAPSULAR CONTRACTURE, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES LEFT CATALOG #: 3505501BC, LEFT SERIAL #: (B)(4), RIGHT CATALOG #: 3505751BC, RIGHT SERIAL #: (B)(4) ON (B)(6) 2021. UPON EXPLANTATION, THE IMPLANTS WERE FOUND TO BE RUPTURED. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2020 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12822759 ↗