MENTOR MemoryGel Xtra Breast Implant SMHX330Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10081317027734), received between Sep 24, 2022 and Sep 16, 2026 — classified as 93 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 99 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 35-year-old female patient underwent a primary breast augmentation with a 330cc (Left) MENTOR MemoryGel Xtra Breast Implant and a 310cc (Right) MENTOR MemoryGel Xtra Breast Implant and experienced bilateral capsular contracture (baker grade 4) post-operatively. As a result, the patient underwent explantation on (b)(6)2026, and replaced with two 400cc MENTOR MemoryGel Xtra Breast Implants.This report is for the left side device.

  Patient problems: Capsular Contracture

  MAUDE report 50793175 ↗
• MalfunctionSep 8, 2026Material Rupture

  It was reported that a 330cc MENTOR MemoryGel Xtra Breast Implant prosthesis was found ruptured during a Primary Breast Augmentation Surgery prior to being implanted into the patient. However, the surgery commenced without any reported delays and a new implant was used to complete the implantation. There were no reported patient consequences/harms.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673375 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION 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 AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24559797 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 24488756 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. THE BREAST WAS FIRM AND SITTING HIGHER THAN THE CONTRALATERAL SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A MENTOR BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24475534 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24458401 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED LOCAL REACTION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX330; SERIAL NUMBER (B)(6) ON (B)(6) 2025.

  Patient problems: Local Reaction

  MAUDE report 24304998 ↗
• MalfunctionJan 13, 2026Material Rupture

  IT WAS REPORTED THAT A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION RUPTURED BEFORE BEING PLACED ON THE PATIENT. 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 24062911 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23980564 ↗
• InjuryDec 30, 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 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE WITH ASSOCIATED PAIN AND DISCOMFORT. 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 23931195 ↗
• InjuryDec 23, 2025Adverse 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 AUGMENTATION WITH TWO 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST SEROMAS POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BREAST CYSTS AND HAD A BREAST MASS ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Mass; Cyst(s); Seroma

  MAUDE report 23881059 ↗
• InjuryDec 23, 2025Adverse 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 AUGMENTATION WITH TWO 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST SEROMAS POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BREAST CYSTS AND HAD A BREAST MASS ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Seroma

  MAUDE report 23881040 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX350; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMHX350; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23790728 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER SMHX350; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMHX350; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23790723 ↗
• InjuryDec 11, 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 A 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23775502 ↗
• InjuryNov 26, 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 23659173 ↗
• InjuryNov 26, 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 23659170 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL XTRA BREAST IMPLANT 330CC GEL BREAST PROSTHESIS WAS NOTICED TO BE RUPTURED. THE RUPTURE WAS OBSERVED PRIOR TO SURGERY. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633430 ↗
• InjurySep 10, 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 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 23017669 ↗
• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SCHEDULED PRIMARY BREAST AUGMENTATION PROCEDURE, A MENTOR MEMORYGEL XTRA BREAST IMPLANT 330CC GEL BREAST PROSTHESIS WAS OBSERVED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MENTOR MEMORYGEL XTRA BREAST IMPLANT 330CC GEL BREAST PROSTHESIS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955852 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA, 330CC SILICONE PROSTHESIS EXPERIENCE RIGHT SIDED CAPSULAR CONTRACTURE GRADE III POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL 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 22905577 ↗
• InjuryAug 27, 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 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22904727 ↗
• InjuryAug 19, 2025Migration; Migration

  IT WAS REPORTED THAT A 49-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT, AND WITH 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY. ON (B)(6) 2025, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL DEVICE MALPOSITION IN ADDITION TO RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. THE DEVICES WERE EXPLANTED ON (B)(6) 2025. PER INFORMATION RECEIVED, THE RIGHT SIDE WAS REPLACED WITH SERIAL NUMBER (B)(6). THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22840076 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22796132 ↗
• InjuryAug 11, 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 330CC 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 22777594 ↗