MENTOR MemoryGel Xtra Breast Implant SMPX545Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00081317025115), received between Aug 5, 2019 and Aug 6, 2026 — classified as 49 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 52-year-old Caucasian female patient underwent a breast augmentation revision with a 545cc MENTOR MemoryGel Xtra Breast Implant and experienced capsular contracture (baker grade 2) on the right side 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.

  Patient problems: Capsular Contracture

  MAUDE report 50161410 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE 2ND OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 24654468 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24642974 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24641696 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL ON AN UNDISCLOSED DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 24641694 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: Capsular Contracture

  MAUDE report 24627366 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23087443 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6), 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22137575 ↗
• InjuryApr 29, 2025Adverse 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 A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTEXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. ADDITIONAL SYMPTOMS INCLUDE PAIN AND HARDNESS.

  Patient problems: Capsular Contracture

  MAUDE report 21930988 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A BREAST SURGERY WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, EARLY MENOPAUSE, CHRONIC FATIGUE, BRAIN FOG, MEMORY PROBLEMS, JOINT ACHES, MUSCLE ACHES, HAIR LOSS, DIGESTION ISSUES, CHRONIC DRY EYES, SKIN RASHES, CHEST PAIN, AND BREATHING DIFFICULTIES POST-OPERATIVELY. IT WAS ALSO REPORTED THAT IN 2023, THE PATIENT WAS DIAGNOSED WITH DUCTAL CARCINOMA IN SITU (DCIS) IN THE RIGHT BREAST, WHICH WAS ADDRESSED WITH A MASTECTOMY. BREAST IMPLANT REMOVAL SURGERY HAD NOT BEEN PERFORMED ON THE RIGHT SIDE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21914576 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A BREAST SURGERY WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, EARLY MENOPAUSE, CHRONIC FATIGUE, BRAIN FOG, MEMORY PROBLEMS, JOINT ACHES, MUSCLE ACHES, HAIR LOSS, DIGESTION ISSUES, CHRONIC DRY EYES, SKIN RASHES, CHEST PAIN, AND BREATHING DIFFICULTIES POST-OPERATIVELY. IT WAS ALSO REPORTED THAT IN 2023, THE PATIENT WAS DIAGNOSED WITH DUCTAL CARCINOMA IN SITU (DCIS) IN THE RIGHT BREAST, WHICH WAS ADDRESSED WITH A MASTECTOMY. BREAST IMPLANT REMOVAL SURGERY HAD NOT BEEN PERFORMED ON THE RIGHT SIDE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Cancer

  MAUDE report 21914569 ↗
• InjuryMar 21, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21663482 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT SIDE. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21381358 ↗
• InjuryJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED POSSIBLE LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

  Patient problems: Breast Cancer; Cancer; Deformity/ Disfigurement

  MAUDE report 19581690 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT IS PART OF A POST APPROVAL STUDY.

  Patient problems: Capsular Contracture

  MAUDE report 19479115 ↗
• InjuryMar 20, 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 SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18940235 ↗
• InjuryNov 28, 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 A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III TO IV CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 18223494 ↗
• InjuryOct 20, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV), AND RIGHT BREAST IMPLANT SLIGHT BOTTOMING OUT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE RIGHT BREAST IMPLANT WAS OBSERVED TO BE UPSIDE DOWN DURING REMOVAL. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17980112 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV), AND RIGHT BREAST IMPLANT SLIGHT BOTTOMING OUT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE RIGHT BREAST IMPLANT WAS OBSERVED TO BE UPSIDE DOWN DURING REMOVAL. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17980106 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST 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 17686988 ↗
• InjuryAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED VIA REPORT NUMBER 0700280000-2023-8018, RECEIVED THROUGH FDA¿S MEDSUN PROGRAM, THAT A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 545CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2023. THE REPORTED DATE OF IMPLANTATION IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17635048 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17339247 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17313035 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). 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 17313033 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 16895614 ↗