MENTOR MemoryGel Xtra Breast Implant TMPX325Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317025467), received between Feb 26, 2021 and May 14, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19316068 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19316067 ↗
• InjuryMay 9, 2024Adverse 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 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL LOCAL REACTION POSTOPERATIVELY. IT WAS REPORTED THAT THE PATIENT FELT THAT THE BREASTS WERE INFLAMED, HOT, PAINFUL, SWOLLEN, AND SUPPURATION. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2024. THIS REPORT IS FOR THE IMPLANT ON ONE OF THE TWO EFFECTED SIDES.

  Patient problems: Local Reaction

  MAUDE report 19278306 ↗
• InjuryMay 9, 2024Adverse 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 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL LOCAL REACTION POSTOPERATIVELY. IT WAS REPORTED THAT THE PATIENT FELT THAT THE BREASTS WERE INFLAMED, HOT, PAINFUL, SWOLLEN, AND SUPPURATION. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) , 2024. THIS REPORT IS FOR THE IMPLANT ON ONE OF THE TWO EFFECTED SIDES.

  Patient problems: Local Reaction

  MAUDE report 19278303 ↗
• InjuryMar 15, 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 IMPLANTATION OF A 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III AND IV CAPSULAR CONTRACTURE OF THE LEFT AND RIGHT BREASTS, RESPECTIVELY, DURING A FOLLOW-UP VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02199 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 18916572 ↗
• InjuryFeb 22, 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 IMPLANTATION OF A 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST DURING A FOLLOW-UP VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18760338 ↗
• InjuryJul 24, 2023Adverse 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 AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 295CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 325CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17384242 ↗
• InjuryMay 23, 2023Adverse 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 AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 325CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16989615 ↗
• InjuryMay 23, 2023Adverse 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 AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 325CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16989614 ↗
• MalfunctionFeb 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA, 325CC SILICONE PROSTHESIS EXPERIENCED, LEFT-SIDED RUPTURE INTRAOPERATIVELY. THE RUPTURE HAPPENED DURING SURGERY. NO ADVERSE EVENT OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401005 ↗
• InjuryFeb 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH A MENTOR MEMORYGEL XTRA, 350CC SILICONE PROSTHESIS EXPERIENCED, BILATERAL SILENT RUPTURE POSTOPERATIVE. THE RUPTURE DISCOVERED DURING SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON AN UNKNOWN DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16399545 ↗
• InjuryFeb 26, 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 HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. IN ADDITION, THE PATIENT WAS PUT ON MONTELUKAST MEDICATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2021: (LEFT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX325 LOT: 9518335 SN: (B)(4) AND (RIGHT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX325 LOT: 9529899 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11386897 ↗
• InjuryFeb 26, 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 HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS, SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III), POST-PROCEDURE. THE CAPSULAR CONTRACTURES WERE DIAGNOSED VIA PHYSICAL EXAMINATION. IN ADDITION, THE PATIENT WAS PUT ON MONTELUKAST MEDICATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT WITH THE FOLLOWING DEVICES ON FEBRUARY 12, 2021: (LEFT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX325 LOT: 9518335 SN: (B)(4) AND (RIGHT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX325 LOT: 9529899 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11386837 ↗