MENTOR MemoryGel Breast Implant 3546001Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317000945), received between Jul 11, 2018 and Feb 25, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 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 600CC 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 21460825 ↗
• InjuryJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 600CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH A POSSIBLY RUPTURED LEFT BREAST IMPLANT USING 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 19515917 ↗
• InjurySep 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL 600CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SILENT RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH ULTRASOUND/ MRI EXAMINATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17737496 ↗
• InjuryAug 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A POSSIBLY RUPTURED BREAST IMPLANT; HOWEVER, THE AFFECTED SIDE WAS NOT PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION AND EVENT WERE NOT PROVIDED TO MENTOR. 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 17547348 ↗
• InjuryAug 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. MENTOR HAS FOLLOWED UP TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT, HOWEVER, HAS RECEIVED NO ADDITIONAL INFORMATION AT THIS TIME. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17470845 ↗
• InjuryMay 7, 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 AFRICAN AMERICAN FEMALE WHO HAD 600CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL IMPAIRED WOUND HEALING AND LEFT SIDED RUPTURE POST PROCEDURE. IN (B)(6) OF 2022 THE PATIENT UNDERWENT MASTOPEXY AND BREAST AUGMENTATION WITHOUT REPLACEMENT. THE LEFT SIDED DEVICE WAS REPLACED WITH A NEW 600CC MENTOR MEMORYGEL BREAST IMPLANT DUE TO RUPTURE IN (B)(6) 2020. BILATERAL PTOSIS, BILATERAL LOCAL REACTION, BILATERAL LYMPHADENOPATHY, RIGHT SIDED CAPSULAR CONTRACTURE, RIGHT SIDED RUPTURE, AND LEFT SIDED BREAST MASS WAS NOTED WITH THE NEW SET OF BREAST IMPLANTS. THE RIGHT SIDED RUPTURE AND BILATERAL LOCAL REACTION WAS DETECTED THROUGH MAGNETIC RESONANCE IMAGING. THE PRESENCE OF PERI IMPLANT EFFUSION WAS NOTED. THE LYMPHADENOPATHY WAS NOTED THROUGH ULTRASOUND WHICH DETECTED PROMINENT LYMPH NODES. THE ULTRASOUND ALSO DETECTED A BENIGN BREAST MASS ON THE LEFT SIDE. AS A RESULT, REPLACEMENT WITH 525CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. THE RIGHT SIDED IMPLANTED WAS REPORTED INITIALLY UNDER 1645337-2021-12569 ON (B)(6) 2021. THE LEFT SIDED DEVICE EXPLANTED ON (B)(6) 2020, WAS REPORTED UNDER 1645337-2021-12568 ON (B)(6

  Patient problems: Breast Mass; Deformity/ Disfigurement; Local Reaction; Swollen Lymph Nodes/Glands

  MAUDE report 14319289 ↗
• InjuryNov 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE WHO HAD 600CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE LEFT SIDED DEVICE WAS REPLACED WITH A NEW HAD 600CC MENTOR MEMORYGEL BREAST IMPLANT DUE TO RUPTURE IN NOVEMBER 2020. THE RIGHT IMPLANT WAS FOUND TO BE RUPTURED ON (B)(6) 2021. THIS IMPLANT IS SCHEDULED FOR EXPLANT ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2021-12569 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement; Impaired Healing

  MAUDE report 12797848 ↗
• InjuryNov 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE WHO HAD 600CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE LEFT SIDED DEVICE WAS REPLACED WITH A NEW HAD 600CC MENTOR MEMORYGEL BREAST IMPLANT DUE TO RUPTURE IN (B)(6) 2020. THE RIGHT IMPLANT WAS FOUND TO BE RUPTURED ON (B)(6) 2021. THIS IMPLANT IS SCHEDULED FOR EXPLANT ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2021-12568 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Impaired Healing; Local Reaction; Swollen Lymph Nodes/Glands

  MAUDE report 12797704 ↗
• InjuryOct 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III AND THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE RUPTURES WERE DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2021-12066 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 12716614 ↗
• InjuryOct 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 600CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE AND BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III AND THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE RUPTURES WERE DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2021-12067 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 12716613 ↗
• InjuryMar 2, 2020Adverse 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 PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A 600CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED BREAST PAIN, ALONG WITH RUPTURE OF LEFT IMPLANT, AND RIGHT-SIDED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. RUPTURE WAS CONFIRMED BY ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9774086 ↗
• InjuryMar 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A 600CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED BREAST PAIN, ALONG WITH RUPTURE OF LEFT IMPLANT, AND RIGHT-SIDED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. RUPTURE WAS CONFIRMED BY ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available; Pain

  MAUDE report 9774084 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A 600CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE, CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH 605CC TEXTURED MENTOR MEMORYGEL XTRA BREAST IMPLANT, CATALOG # TMPX605, RIGHT SERIAL # (B)(4) ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9753735 ↗
• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED GRADE 3 CAPSULAR CONTRACTURE. THE PATIENT EXPERIENCED PAIN AND TIGHTNESS, AND CAPSULAR CONTRACTURE WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3546001, SERIAL # (B)(4) ON (B)(6) 2018.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9170309 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL 600CC SILICONE BREAST IMPLANTS WHICH PATIENT EXPERIENCING SEROMA AND CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AFTER THE IMPLANTATION. ON (B)(6) 2019 PHYSICIAN REMOVED THE CAPSULE PUT THE IMPLANT BACK IN. ON (B)(6) 2019, PHYSICIAN DRAINED SEROMA. INFLAMMATION ALSO REPORTED. PATIENT HAD ULTRASOUND SHOWING FLUID COLLECTION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 8803517 ↗
• InjuryJun 26, 2019Adverse 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 PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III THE LEFT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8737903 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL SX MPP GEL 400 CC, GEL BREAST IMPLANT ON THE LEFT AND ON THE RIGHT MENTOR MEMORYGEL SILTEX ROUND MODERATE PROFILE 600 CC WHICH THE LEFT SIDE RUPTURED, AND ISSUE WITH CAPSULAR CONTRACTURE BILATERALLY AFTER IMPLANTATION. THE ISSUE WAS DIAGNOSED DURING THE SURGERY. AS A RESULT PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH ALLERGAN DEVICES AS FOLLOW: RIGHT CATALOG NUMBER SSM-640, SERIAL (B)(4), AND LEFT REPLACED WITH CATALOG NUMBER SSM640, SERIAL (B)(4) ON (B)(6) 2018. THIS REPORT IS FOR THE RIGHT.

  Patient problems: Capsular Contracture

  MAUDE report 7677733 ↗