MENTOR MemoryGel Xtra Breast Implant SMPX685Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00081317025160), received between Sep 25, 2019 and Aug 21, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANT WAS FOUND TO HAVE A HAIR BEFORE IT WAS PLACED ON THE FIELD. NO ADVERSE EVENT WAS EXPERIENCED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868514 ↗
• InjuryApr 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 BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 685CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21754394 ↗
• InjuryMar 10, 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 685CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT 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 21562296 ↗
• InjuryMay 27, 2024Adverse 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 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PALPABLE BREAST MASSES, WHICH WERE IDENTIFIED VIA MAGNETIC RESONANCE IMAGING. IMAGING ALSO INDICATED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Breast Mass

  MAUDE report 19402042 ↗
• InjuryMay 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PALPABLE BREAST MASSES, WHICH WERE IDENTIFIED VIA MAGNETIC RESONANCE IMAGING. IMAGING ALSO INDICATED THAT THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Breast Mass; Deformity/ Disfigurement; Wrinkling

  MAUDE report 19402041 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A SEROMA AND A DEVICE EXTRUSION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Pocket Erosion; Seroma

  MAUDE report 19197147 ↗
• InjuryOct 19, 2023Adverse 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 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. IT WAS REPORTED THAT THE PATIENT HAD SURGERY TO CORRECT HER IMPLANT BECAUSE ONE OF THE IMPLANTS HAD DROPPED. SURGERY HAPPENED A FEW MONTHS AFTER DATE OF ORIGINAL IMPLANT. RIGHT SERIAL NUMBER: (B)(6). LEFT SERIAL NUMBER: (B)(6). MENTOR IS AWARE THAT THE MANUFACTURING DATE (SEPTEMBER 6, 2019) OF LOT 9363779 IS AFTER THE DATE OF EVENT ((B)(6) 2019). MULTIPLE FOLLOW UPS WERE COMPLETED FOR CLARIFICATION. HOWEVER, NO RESPONSE WAS RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE UPDATED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17968667 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 685CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 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 17490696 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED 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 16963133 ↗
• InjuryMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA, 685CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH OFFICE VISITATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16903099 ↗
• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 685CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16569873 ↗
• MalfunctionFeb 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A ¿STRANGE FILM¿ WAS NOTICED ON A MENTOR MEMORYGEL XTRA BREAST IMPLANT 685CC GEL BREAST PROSTHESIS AND THAT THE SURGEON WAS NOT COMFORTABLE IMPLANTING THE DEVICE IN A PATIENT. THE DEVICE DID NOT COME INTO CONTACT WITH ANY PATIENT AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315414 ↗
• InjuryApr 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 685CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 14025447 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 685CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND DEFORMITY ASSOCIATED WITH THE RIGHT BREAST. SUBSEQUENTLY, A MEDICAL PROFESSIONAL DIAGNOSED THE PATIENT WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST. AS A RESULT, THE PATIENT WILL UNDERGO UNILATERAL REMOVAL ON A (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 13698285 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION WITH A 685CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST, SUFFERED IMPLANT EXPOSURE, DEHISCENCE, POST-PROCEDURE. THE COMPLICATION WAS DIAGNOSED DURING A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2021.

  Patient problems: Pocket Erosion

  MAUDE report 13338512 ↗
• InjuryOct 8, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 685CC GEL BREAST PROSTHESIS SUFFERED FROM MIGRATION OF THE LEFT BREAST PROSTHESIS POST IMPLANTATION. IT WAS REPORTED THAT THE LEFT BREAST WAS PUSHED TO THE SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 685CC GEL BREAST PROSTHESIS ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12601392 ↗
• InjuryJul 15, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 685CC MENTOR MMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PATIENTS¿ SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12173356 ↗
• InjuryJul 15, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 685CC MENTOR MMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PATIENTS SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12173242 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 685CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE IV CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BASED ON THE PATIENT¿S SYMPTOMS. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO UNILATERAL EXPLANTATION ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 11164312 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 685CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITH NO REPLACEMENT DEVICE ON (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10658394 ↗
• InjurySep 25, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-00514916. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 685CC GEL BREAST PROSTHESES THAT BILATERALLY RUPTURED AFTER IMPLANTATION. THE PATIENT FIRST NOTICED THE RIGHT PROSTHESIS HAD RUPTURED, THEN LATER NOTICED THE LEFT PROSTHESIS HAD RUPTURED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9118691 ↗