MENTOR MemoryGel Xtra Breast Implant SHPX465Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00081317025290), received between Jun 6, 2019 and Mar 20, 2026 — classified as 107 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 115 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE CONSULTED WITH A MEDICAL PROFESSIONAL AFTER EXPERIENCING AN ENLARGED AND PAINFUL RIGHT BREAST AND WAS DIAGNOSED WITH A RIGHT BREAST SEROMA. ADDITIONALLY, SHE EXPERIENCED SHOOTING PAINS UNDER BOTH ARMPITS, ITCHY, PAINFUL, HOT, RED, AND HEAVY BREASTS WITH RIPPLING, AND A LEFT BREAST THAT FEELS LIKE JELLO. THE RIGHT BREAST BECAME HARD AND SHE HAS DIFFICULTY SLEEPING. AFTER CONSULTING AGAIN, SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Paresthesia; Seroma

  MAUDE report 24654751 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED SHE CONSULTED WITH A MEDICAL PROFESSIONAL AFTER EXPERIENCING AN ENLARGED AND PAINFUL RIGHT BREAST AND WAS DIAGNOSED WITH A RIGHT BREAST SEROMA. ADDITIONALLY, SHE EXPERIENCED SHOOTING PAINS UNDER BOTH ARMPITS, ITCHY, PAINFUL, HOT, RED, AND HEAVY BREASTS WITH RIPPLING, AND A LEFT BREAST THAT FEELS LIKE JELLO. THE RIGHT BREAST BECAME HARD AND SHE HAS DIFFICULTY SLEEPING. AFTER CONSULTING AGAIN, SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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; Local Reaction; Paresthesia; Wrinkling

  MAUDE report 24654745 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS FOUND TO HAVE A MALIGNANT CONDITION. IT WAS ALSO REPORTED THAT THE IMPLANTS WERE REMOVED ON (B)(6) 2026; HOWEVER, INFORMATION ABOUT THE UNDERLYING CONDITION AND THE REASON FOR REMOVAL IS ABSENT. AT THIS TIME, NO PATHOLOGY/CYTOLOGY RESULTS HAVE BEEN PROVIDED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Cancer

  MAUDE report 24517483 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS FOUND TO HAVE A MALIGNANT CONDITION. IT WAS ALSO REPORTED THAT THE IMPLANTS WERE REMOVED ON (B)(6) 2026; HOWEVER, INFORMATION ABOUT THE UNDERLYING CONDITION AND THE REASON FOR REMOVAL IS ABSENT. AT THIS TIME, NO PATHOLOGY/CYTOLOGY RESULTS HAVE BEEN PROVIDED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cancer

  MAUDE report 24517481 ↗
• InjuryFeb 10, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Contracture

  MAUDE report 24307703 ↗
• InjuryJan 8, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24014522 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24012506 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23970360 ↗
• InjuryDec 24, 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 PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 465CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 380CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23889383 ↗
• InjuryDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3), IMPLANT SITE FLUID COLLECTION, AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707996 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23707728 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING 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 22905188 ↗
• InjuryJun 12, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 465CC AND EXPERIENCED DEVICE MIGRATION ON THE LEFT SIDE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22195915 ↗
• InjuryJun 5, 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 SURGERY WITH 465CC MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER ON ONE SIDE, AND WITH 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. THE COMPLAINT IS FOR LABELING ON THE SIZER BOXES ARE NOT CLEARLY DEFINED AS A SIZER AND NEEDS TO BE UPDATED. THE PATIENT HAD TO BE REOPENED AND THE PROPER IMPLANT WAS PLACED. THIS RESULTED IN SURGICAL DELAY (AN ADDITIONAL 20 MINUTES OF SURGERY AND NEAR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153263 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED PAIN AND CAPSULAR CONTRACTURE (BAKER GRADE 3-4) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SHPX465).

  Patient problems: Capsular Contracture

  MAUDE report 22049032 ↗
• InjuryMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDEWRWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22042059 ↗
• InjuryApr 21, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 465CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21875742 ↗
• InjuryMar 28, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYGEL XTRA, 465CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST OPERATION. THE PROBLEM WAS DIAGNOSED VIA ULTRASOUND. AS A RESULT, PATIENT UNDERWENT RIGHT SIDED REPLACEMENT WITH RIGHT CATALOG NUMBER SHPX465, SERIAL NUMBER (B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21724924 ↗
• InjuryMar 19, 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 465CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING 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 21644917 ↗
• InjuryMar 13, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 465CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, MAMMOGRAM/ULTRASOUND SCANS INDICATED THAT THE PATIENT DEVELOPED A CLUSTER CYST IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE RIGHT BREAST PROSTHESIS ON (B)(6) 2024. THE EXPLANTED DEVICE WAS REPLACED WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 465CC GEL BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-12481 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s)

  MAUDE report 21602036 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 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 21367172 ↗
• InjuryFeb 6, 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 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PTOSIS AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21323733 ↗
• InjuryFeb 6, 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 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PTOSIS AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21323732 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 465CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21280308 ↗
• InjuryDec 10, 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 AUGMENTATION REVISION WITH MENTOR MEMORYGEL, 465CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POSTOPERATIVE. THE ISSUE WAS CONFIRMED ON MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20893754 ↗