MENTOR MemoryGel Xtra Breast Implant SMHX545Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10081317027895), received between May 19, 2022 and Mar 2, 2026 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (8 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 24489203 ↗
• InjuryDec 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE, BILATERAL DEVICE MALPOSITION, AND HAD A RIGHT SIDED BREAST LUMP. AS A RESULT, EXPLANT AND REPLACEMENT WAS PERFORMED ON WAS PERFORMED ON (B)(6) 2025. THE RIGHT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2025-07437. ON (B)(6) 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23707722 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A 500CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2-3 ON THE RIGHT AND BAKER GRADE 3-4 ON THE LEFT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23373007 ↗
• InjurySep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22947269 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE II 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 22716914 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED EARLY ONSET SEROMA ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED WITH A CT SCAN. THE PATIENT HAD AN INCISION AND DRAINAGE PROCEDURE TO TREAT THE ABSCESS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Abscess; Seroma

  MAUDE report 22680074 ↗
• InjuryJul 30, 2025Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL IMPLANT DISPLACEMENT AND THE PATIENT DESIRED AN INCREASE IN SIZE/VOLUME OF THE LEFT SIDE TO MATCH THE RIGHT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAPSULORRHAPHY, UNILATERAL LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT, AND RIGHT-SIDED IMPLANT REMOVAL AND REIMPLANTATION (B)(6) 2025. FURTHERMORE, DURING THE SURGERY, A RUPTURED LEFT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE FINDINGS. MENTOR MEMORYGEL XTRA BREAST IMPLANTS ARE NOT INTENDED FOR REUSE/REIMPLANTATION, THUS THE USER USED THE DEVICE IN ERROR. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22665638 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 22417114 ↗
• InjuryMay 27, 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 TWO 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22089993 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX375; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMHX375; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21910108 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX375; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMHX375; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6), 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21910101 ↗
• InjuryFeb 24, 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 PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 545CC 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 ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21450463 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS NOTICED THAT THE PLACEMENT OF HER RIGHT BREAST PROSTHESIS WAS NOT EVEN AND THE SIZING WAS DIFFERENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 580CC GEL BREAST PROSTHESIS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21367994 ↗
• InjuryJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21060857 ↗
• InjurySep 25, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 545CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20304771 ↗
• InjuryApr 11, 2024Adverse 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 MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-02355 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19091015 ↗
• InjuryMar 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18952590 ↗
• InjuryFeb 26, 2024Adverse 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 CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18779564 ↗
• MalfunctionFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED FOR A PRIMARY BREAST AUGMENTATION PROCEDURE ON THE LEFT SIDE RUPTURED INTRAOPERATIVELY. NO FUNNEL WAS USED AS WAS MASTOPEXY INCISION. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650331 ↗
• InjuryNov 9, 2023Adverse 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 MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL NIPPLE SCAR INDENTATION. AS A RESULT, ON (B)(6) 2023, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE LEFT BREAST PROSTHESIS AND IT WAS REPLACED WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS. ADDITIONALLY, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REVISE THE RIGHT BREAST NIPPLE SCAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Scar Tissue

  MAUDE report 18102458 ↗
• InjuryNov 9, 2023Adverse 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 MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL NIPPLE SCAR INDENTATION. AS A RESULT, ON (B)(6) 2023, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE LEFT BREAST PROSTHESIS AND IT WAS REPLACED WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 545CC GEL BREAST PROSTHESIS. ADDITIONALLY, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REVISE THE RIGHT BREAST NIPPLE SCAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18102457 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 17740543 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURED RIGHT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. SUBSEQUENTLY, DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS OBSERVED TO HAVE BILATERAL PTOTIC BREASTS/BREAST MOUNDS AND BILATERAL CONTOUR DEFORMITIES OF THE BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH NATRELLE BREAST IMPLANTS ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-05973 FOR THE CONTRALATERAL EVENT.

  Patient problems: Cyst(s); Deformity/ Disfigurement; Wrinkling

  MAUDE report 17542189 ↗
• InjuryJul 11, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT A 50 -YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 545CC MENTOR MEMORYGEL XTRA SILICONE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE IV ON THE RIGHT, AND GRADE II ON THE LEFT SIDE POST PROCEDURE. THE PATIENT SYMPTOMS DIAGNOSED THE ISSUE. AS A RESULT, PATIENT UNDERWENT UNILATERAL RIGHT-SIDE REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17299233 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50 -YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 545CC MENTOR MEMORYGEL XTRA SILICONE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE IV ON THE RIGHT, AND GRADE II ON THE LEFT SIDE POST PROCEDURE. THE PATIENT SYMPTOMS DIAGNOSED THE ISSUE. AS A RESULT, PATIENT UNDERWENT UNILATERAL RIGHT-SIDE REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17270966 ↗