MENTOR MemoryGel Xtra Breast Implant SHPX380Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 00081317025269), received between Sep 23, 2019 and Sep 11, 2026 — classified as 147 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (38 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 155 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50737317 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 380cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with left breast Baker Grade IV Capsular Contracture which was thick and painful. As a result, the patient underwent left-sided exchange with a Mentor gel implant on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50674758 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 380cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with left breast Baker Grade III Capsular Contracture during a physical exam. 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.

  Patient problems: Capsular Contracture

  MAUDE report 50116080 ↗
• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25205744 ↗
• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25205727 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS

  Patient problems: Capsular Contracture

  MAUDE report 24682879 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS PLACED EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE AND LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24675390 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS PLACED EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE AND LEFT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24675388 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT WAS SCHEDULED FOR LEFT-SIDED IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24618107 ↗
• InjuryMar 12, 2026Adverse 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 GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24576823 ↗
• InjuryMar 11, 2026Adverse 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 GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24573126 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT HAD TO UNDERGO A RIGHT BREAST MASTOPEXY REVISION ON (B)(6) 2024. IN ADDITION, THE PATIENT ALSO DEVELOPED LEFT BREAST HEMATOMA, WHICH WAS ASPIRATED ON AN UNSPECIFIED DATE. THE PATIENT EVENTUALLY DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT. FOR THE RIGHT IMPLANT, 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: Deformity/ Disfigurement

  MAUDE report 24479742 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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 24326525 ↗
• MalfunctionJan 4, 2026Material Rupture

  IT WAS REPORTED THAT A 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION PROCEDURE 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 23954144 ↗
• InjuryJan 3, 2026Migration

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEVICE MIGRATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A TWO 450CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23953589 ↗
• InjuryJan 3, 2026Migration

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEVICE MIGRATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A TWO 450CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23953588 ↗
• InjuryDec 26, 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 SURGERY WITH IMPLANTATION OF A 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. 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.

  Patient problems: Capsular Contracture

  MAUDE report 23897856 ↗
• 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23889384 ↗
• InjuryAug 15, 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 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST HEMATOMAS DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 22822191 ↗
• InjuryAug 1, 2025Adverse 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 IMPLANTATION OF A MENTOR 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST PAIN, PRESSURE, AND HARDNESS. DURING AN IN-OFFICE VISIT, SHE WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL EXCHANGE ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22689675 ↗
• InjuryJul 21, 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 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 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 22556589 ↗
• InjuryJul 21, 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 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 3 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 22556584 ↗
• InjuryJul 2, 2025Adverse 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 IMPLANTATION OF A 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III-IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2025. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 22391068 ↗
• InjuryJun 10, 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 TWO 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22173693 ↗
• InjuryMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 380CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22043193 ↗