MENTOR MemoryGel Xtra Breast Implant SMHX580Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10081317027901), received between Apr 20, 2022 and Mar 19, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 24640212 ↗
• InjuryJul 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CONTOUR DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS DISCOVERED TO BE RUPTURED AND THE LEFT BREAST IMPLANT TO BE FLIPPED. SUBSEQUENTLY, BOTH IMPLANTS WERE REPLACED WITH TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22528122 ↗
• InjuryJul 17, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CONTOUR DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS DISCOVERED TO BE RUPTURED AND THE LEFT BREAST IMPLANT TO BE FLIPPED. SUBSEQUENTLY, BOTH IMPLANTS WERE REPLACED WITH TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22528121 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. THE PATIENT HAD HARDNESS AND PRESSURE ON THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 580CC MENTOR MODERATE HIGH XTRA WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 21551657 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA, 580CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED BREAST PAIN FOLLOWING IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 21379432 ↗
• InjuryNov 27, 2024Material Discolored; Material Discolored

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL XTRA, 580CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV, AND DISCOLORED IMPLANT POSTOPERATIVE. THE IN OFFICE/ DURING REVISION EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULORRAPHY, AND BILATERAL REPLACEMENT AS FOLLOW; L) SHPX650/ (B)(6), R) SHPX650/ (B)(6) ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20799032 ↗
• InjuryMay 22, 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 PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA, 580CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19376552 ↗
• InjuryMay 22, 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 PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA, 580CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 19376395 ↗
• InjuryMay 15, 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 REVISION SURGERY WITH A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 630CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19324441 ↗
• InjuryMay 13, 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 REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 580CC 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 AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19298190 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18926709 ↗
• InjuryNov 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURED ACCOMPANIED BY DEVICE MALPOSITION POST PROCEDURE. THE RUPTURE WAS DISCOVERED DURING EXPLANT. EXPLANT AND REPLACEMENT WERE PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18242600 ↗
• InjurySep 18, 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 RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HER LEFT BREAST WAS LARGER THAN THE RIGHT AND SHE HAD LOOSE SKIN OF THE LEFT BREAST. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17765802 ↗
• InjuryFeb 14, 2023Defective Device; Material Deformation; Migration; Defective Device; Material Deformation; Migration

  IT WAS REPORTED THAT A 46-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 580CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED BUBBLES IN THE IMPLANT POST PROCEDURE. THE REPORT STATED THAT THERE ARE TWO BUBBLES IN PATIENTS IMPLANT, AND THE DEVICE IS DEFECTIVE. PRIOR TO SURGERY IT WAS THOUGHT THAT THE DEVICE WAS MISPOSITIONED, AFTER THE EXPLANT IT WAS OBSERVED THAT THE IMPLANT HAVE BUBBLES. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH CAT#: SMHX580, SN#: (B)(4) ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16373190 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A LEFT-SIDED 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A RIGHT-SIDED 580CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT HAD DIFFICULTY BREATHING DEEPLY, DIFFICULTY SLEEPING, EXHAUSTION AND SEVERE FATIGUE. THE PATIENT EXPERIENCED BILATERAL BREAST DISCOMFORT AS WELL AS CAPSULAR CONTRACTURE OF AN UNKNOWN BAKER GRADE AND SWELLING OF THE LEFT BREAST. THE PATIENT ALSO REPORTED THAT SHE SUSPECTED THAT HER LEFT BREAST IMPLANT MAY HAVE RUPTURED. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15196 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16010117 ↗
• InjuryNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL XTRA, 580CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH CAT#: SMHX-580, SN#: (B)(4) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15726406 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 580CC (LEFT) AND A 470CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022 FOR THE LEFT SIDE ONLY. SURGICAL INTERVENTION WAS REPORTED ON THE RIGHT. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15205030 ↗
• InjuryAug 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 580 CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST AND SUFFERED RIGHT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15169958 ↗
• InjuryMay 19, 2022Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 580CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14438498 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANTS 580CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14438407 ↗
• InjuryMay 16, 2022Adverse 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 A 580CC SMOOTH MODERATE HIGH PROFILE XTRA AND EXPERIENCED WOUND INFECTION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMHX580; SERIAL NUMBER (B)(4) ON (B)(6) 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14414225 ↗
• InjuryApr 20, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SMOOTH MODERATE HIGH PROFILE XTRA, 580 CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14162549 ↗