MENTOR MemoryGel Xtra Breast Implant SHPX335Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00081317025245), received between Mar 5, 2020 and Mar 19, 2026 — classified as 84 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 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 90 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 A BREAST SURGERY WITH IMPLANTATION OF A 335CC 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 24642897 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A HEMATOMA OF THE LEFT BREAST USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 24309416 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24193435 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24193426 ↗
• InjuryNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE, AND WITH UNKNOWN SIZE UNKNOWN GEL IMPLANT ON THE RIGHT SIDE AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, CAPSULAR CONTRACTURE; BAKER GRADE III, IMPLANT SITE FLUID COLLECTION, AND BILATERAL SWOLLEN LYMPH NODES POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2025. IT WAS FURTHER REPORTED THAT LEFT SIDE REPLACEMENT DEVICE USED WAS CATALOG NUMBER SHPX335; SERIAL NUMBER (B)(6). THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 23604794 ↗
• InjurySep 19, 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 BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23098012 ↗
• InjurySep 19, 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 BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23098010 ↗
• MalfunctionJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS RUPTURED DURING A PRIMARY BREAST AUGMENTATION SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446817 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE WITH BREAST PAIN POST PROCEDURE. THE RIGHT SIDED HAD A BURNING SENSATION WHEN TOUCHED AND FLATTENING. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22413546 ↗
• InjuryJul 7, 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 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED LEFT SIDED BAKER GRADE II CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE WITH BREAST PAIN POST PROCEDURE. THE RIGHT SIDED HAD A BURNING SENSATION WHEN TOUCHED AND FLATTENING. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22413544 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21699287 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21699277 ↗
• InjuryMar 25, 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 REVISION SURGERY WITH IMPLANTATION OF A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF AN UNDISCLOSED SIDE USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2024. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 21690399 ↗
• InjuryMar 20, 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 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21659915 ↗
• MalfunctionFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL XTRA BREAST IMPLANT 335CC BEING USED IN A BREAST AUGMENTATION WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365142 ↗
• InjuryJan 6, 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 335CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21085676 ↗
• InjuryJan 6, 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 335CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21085673 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III), PTOSIS, RIGHT BREAST CAPSULAR CONTRACTURE (UNSPECIFIED BAKER GRADE) AND RIGHT BREAST DROOPING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST LIFT, SCAR REVISION ON THE RIGHT BREAST, AND LEFT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON SEPTEMBER 24, 2024. THE RIGHT BREAST IMPLANT WAS NOT REMOVED OR REPLACED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20690454 ↗
• InjuryNov 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING ULTRASOUND IMAGING AND DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(4) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20593828 ↗
• InjurySep 12, 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 PRIMARY WITH A MENTOR MEMORYGEL, XTRA 335CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE III POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT UNDERWENT RIGHT SIDED CAPSULECTOMY AND REPLACEMENT WITH SN: (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20202827 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 335CC 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) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20147857 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED A CLINICAL STUDY UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NEW UNSPECIFIED BREAST IMPLANTS. THE REASON FOR REMOVAL WAS NOT DISCLOSED TO MENTOR. NO DATE OF EXPLANTATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19461917 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED A CLINICAL STUDY UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NEW UNSPECIFIED BREAST IMPLANTS. THE REASON FOR REMOVAL WAS NOT DISCLOSED TO MENTOR. NO DATE OF EXPLANTATION WAS PROVIDED. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19461916 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19393060 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 335CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19393007 ↗