MENTOR MemoryGel Xtra Breast Implant SMHX775Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10081317027932), received between Oct 21, 2021 and Sep 23, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Migration

  It was reported that a patient with MENTOR MemoryGel Xtra Breast Implants experienced device migration on the left side and capsular contracture Baker Grade III on the right side. As a result, the patient underwent device removal and replacement of the right breast prosthesis. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date for the left breast prosthesis. This report is for the left breast prosthesis.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50871137 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24634911 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24630847 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 775CC (LEFT) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A 275CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL ANISOMASTIA POST-OPERATIVELY. THE PATIENT UNDERWENT A BREAST LIFT. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 790CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT AND A 235CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24203494 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 775CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2025. THE EXPLANTED BREAST PROSTHESIS WAS REPLACED WITH A NEW MENTOR MEMORYGEL XTRA BREAST IMPLANT 775CC GEL BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23600882 ↗
• InjuryAug 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING COMPUTERIZED TOMOGRAPHY IMAGING. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19983798 ↗
• 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 AUGMENTATION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT'S LEFT BREAST WAS OBSERVED TO BE SITTING HIGH DURING A FOLLOW-UP VISIT WITH A MEDICAL PROFESSIONAL. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL SUGGESTED THE PATIENT MAY HAVE HAD A HEMATOMA OF THE LEFT BREAST AS SHE STATED SHE HAD BRUISING OF THE LEFT BREAST AFTER THE IMPLANTATION SURGERY. ON A SECONDARY FOLLOW-UP VISIT, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 17769457 ↗
• InjurySep 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT AND A RIGHT BREAST MASS USING MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-10542 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17699464 ↗
• InjurySep 7, 2023Adverse 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 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT AND A RIGHT BREAST MASS USING MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-10541 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Mass

  MAUDE report 17699462 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 775CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED FIRMNESS AND TENDERNESS OF THE LEFT BREAST. DURING A FOLLOW-UP VISIT WITH A MEDICAL PROFESSIONAL, SHE WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL 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 17118675 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 32-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 775CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16903954 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 775CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 14651085 ↗
• InjuryNov 3, 2021Adverse 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 SURGERY WITH A 755CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED AN IMPLANT SITE HEMATOMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Hematoma

  MAUDE report 12745779 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 755CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED AN INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12677559 ↗