MENTOR MemoryGel Breast Implant 3544457MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317004462), received between May 7, 2019 and Mar 28, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• InjuryMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 445CC AND EXPERIENCED BILATERAL RUPTURES. IN ADDITION, THERE WAS SILICONE IN THE LEFT AXILLARY LYMPH NODES AND THE RIGHT AXILLARY LYMPH NODES WERE ABNORMAL (COULD BE SILICONE, BUT IT'S NOT CONFIRMED). AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-00595 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18996438 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 445CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT DESIRED A BILATERAL MASTOPEXY AND LARGER BREAST IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 535CC (LEFT-SIDED) AND 595CC (RIGHT-SIDED) MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2024. 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 RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02037 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18747695 ↗
• InjuryJan 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 445CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 18519337 ↗
• InjuryNov 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 445CC MENTOR MEMORYGEL BREAST IMPLANTS AND MENTIONED HAVING BILATERAL ABNORMALITIES ON THE ¿BACK OF THE IMPLANT¿ POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 SIDE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18221813 ↗
• InjuryNov 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 445CC MENTOR MEMORYGEL BREAST IMPLANTS AND MENTIONED HAVING BILATERAL ABNORMALITIES ON THE ¿BACK OF THE IMPLANT¿ POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 SIDE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18221792 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 445CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED RIGHT BREAST PAIN, DISCOMFORT, AND SORENESS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED; HOWEVER, 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: Breast Discomfort/Pain

  MAUDE report 18052087 ↗
• InjuryAug 1, 2023Gel Leak; Gel Leak

  IT WAS REPORTED THAT A 47-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 445CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE, TWO ENLARGED LYMPH NODES IN THE RIGHT AXILLA, AND RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). THE RIGHT BREAST WAS PALPABLE, HAS VISIBLE DEFORMITY, AND PAIN. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST CYST AND LYMPHADENOPATHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE LEFT BREAST IMPLANT WAS IDENTIFIED TO HAVE A GEL BLEED. THE PATIENT'S IMPLANTS WERE REPLACED BILATERALLY WITH TWO 650CC MENTOR SILICONE IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATIONS ON THE RIGHT BREAST HAVE BEEN REPORTED UNDER MRN: 1645337-2023-05918.

  Patient problems: Cyst(s); Swollen Lymph Nodes/Glands

  MAUDE report 17431783 ↗
• InjuryMay 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 445CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 16955975 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A LEFT-SIDED 510CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED POSSIBLE BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA COMPUTERIZED TOMOGRAPHY SCAN. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04757 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16797776 ↗
• InjurySep 22, 2021Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 445CC GEL BREAST PROSTHESES DEVELOPED BURNING SENSATIONS IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT REPORTED FEELING PINCHING SENSATIONS AND THAT CERTAIN ACTIVITIES WILL ONSET THE BURNING SENSATIONS. 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: Paresthesia

  MAUDE report 12516581 ↗
• InjurySep 22, 2021Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 445CC GEL BREAST PROSTHESES DEVELOPED BURNING SENSATIONS IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT REPORTED FEELING PINCHING SENSATIONS AND THAT CERTAIN ACTIVITIES WILL ONSET THE BURNING SENSATIONS. 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: Paresthesia

  MAUDE report 12516543 ↗
• InjuryApr 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS (445CC ON THE LEFT AND 510CC ON THE RIGHT) EXPERIENCED BILATERAL IMPLANT RUPTURE POSTOPERATIVELY. RUPTURE WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS, 590CC ON THE LEFT ( LEFT CATALOG # 3505590BC AND LOT-SERIAL # (B)(4)) AND 535CC ON THE RIGHT (RIGHT CATALOG # 3505535BC AND LOT-SERIAL # (B)(4)) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11713571 ↗
• InjuryNov 4, 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 UNDERWENT A BREAST RECONSTRUCTION WITH A 445CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE III CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BY THE PATIENT¿S PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 525CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG #:3505251BC , LEFT SERIAL #: (B)(4)) ON (B)(6) 2020. THE DEVICE WAS DISCARDED UPON EXPLANTATION DUE TO COVID-19 CONCERN AND IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10788587 ↗
• InjuryNov 1, 2019Adverse 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 445CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 445CC, CATALOG NUMBER 3507445MC, SERIAL NUMBER (B)(4) (R) AND SERIAL NUMBER (B)(4) (L) ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9267907 ↗
• InjuryAug 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 445CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT¿S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8918971 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 445CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED FATIGUE, BRAIN FOG, MEMORY LOSS, MUSCLE PAIN, JOINT PAIN, PREMATURE AGING, WEIGHT GAIN, INFLAMMATION, VISION CHANGES, HORMONE IMBALANCE, LOW LIBIDO, IRRITABLE BOWEL SYNDROME, HOT FLASHES, DAILY MIGRAINES, HEART PALPITATIONS, BURNING SENSATION UNDER THE SKIN IN BOTH BREASTS, FIBROMYALGIA, ARTHRITIS, AND RANDOM BREAST SORENESS. THERE IS NO INFORMATION INDICATING THIS CASE WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-11265 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Autoimmune Reaction; No Code Available

  MAUDE report 8587827 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 445CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED FATIGUE, BRAIN FOG, MEMORY LOSS, MUSCLE PAIN, JOINT PAIN, PREMATURE AGING, WEIGHT GAIN, INFLAMMATION, VISION CHANGES, HORMONE IMBALANCE, LOW LIBIDO, IRRITABLE BOWEL SYNDROME, HOT FLASHES, DAILY MIGRAINES, HEART PALPITATIONS, BURNING SENSATION UNDER THE SKIN IN BOTH BREASTS, FIBROMYALGIA, ARTHRITIS, AND RANDOM BREAST SORENESS. THERE IS NO INFORMATION INDICATING THIS CASE WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-11258 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Autoimmune Reaction; No Code Available

  MAUDE report 8587821 ↗