MENTOR MemoryGel Xtra Breast Implant SMPX525Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00081317025108), received between Jun 1, 2019 and Aug 24, 2026 — classified as 63 injuries.

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 63 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a breast reconstruction revision procedure with a MENTOR MemoryGel Xtra Breast Implant gel breast prosthesis developed capsular contracture (Baker Grade unknown) in her right breast post implantation. As a result, the patient underwent explantation and replacement with a MENTOR MemoryGel Xtra Breast Implant gel breast prosthesis

  Patient problems: Capsular Contracture

  MAUDE report 50418994 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED ASYMMETRY POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25319099 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 525 CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL REACTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Local Reaction

  MAUDE report 25057935 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 525 CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL REACTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Local Reaction

  MAUDE report 25057934 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE 1ST OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 24654359 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL XTRA, 525CC SILICONE BREAST PROSTHESIS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POSTOPERATIVE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24641254 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 24446029 ↗
• InjuryDec 9, 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 UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE ON AN UNSPECIFIED BREAST SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23758280 ↗
• InjuryJul 29, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA 525CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED SYMPTOMATIC RUPTURE, CUTANEOUS CONTOUR DEFORMITY, AND PARESTHESIA POST PROCEDURE. THE MRI EXAMINATION CONFIRMED THE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED IMPLANTS ON (B)(6) 2025.

  Patient problems: Nipple Sensation Changes; Paresthesia; Wrinkling

  MAUDE report 22652237 ↗
• InjuryJun 20, 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 TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED) AND RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL RIGHT BREAST IMPLANT REMOVAL ON (B)(6) 2025. FOR THE LEFT BREAST, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22303118 ↗
• InjuryMar 12, 2025Adverse 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 REVISION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED LEFT SIDED FLUID ACCUMULATION AND BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. DIAGNOSIS WAS MADE THROUGH A PHYSICAL EXAMINATION. AS A RESULT, REPLACEMENT WITH MENTOR DEVICES WAS PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 21582673 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS ACCOMPANIED BY PAIN, TIGHTNESS, AND THE RIGHT IMPLANT SITTING HIGHER. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20400969 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 525CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. IT WAS REPORTED THAT BOTH BREASTS WERE SWOLLEN AND ARE HURTING. A HEALTHCARE PROFESSIONAL LATER DIAGNOSED BAKER GRADE IV CAPSULAR CONTRACTURE IN THE LEFT BREAST. THE BAKER GRADE FOR THE RIGHT BREAST IS UNKNOWN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19801951 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 525CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. IT WAS REPORTED THAT BOTH BREASTS WERE SWOLLEN AND ARE HURTING. A HEALTHCARE PROFESSIONAL LATER DIAGNOSED BAKER GRADE IV CAPSULAR CONTRACTURE IN THE LEFT BREAST. THE BAKER GRADE FOR THE RIGHT BREAST IS UNKNOWN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19799969 ↗
• InjuryJul 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 525CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH RUPTURE 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 19690471 ↗
• InjuryJun 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19469349 ↗
• InjuryMar 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 PRIMARY BREAST AUGMENTATION WITH 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL ANISOMASTIA POST PROCEDURE. THE PATIENT NOTED THAT THE SHAPE WAS DIFFERENT, AND THE RIGHT IMPLANT FELT DIFFERENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2024-03201 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18909512 ↗
• InjuryMar 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 PRIMARY BREAST AUGMENTATION WITH 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL ANISOMASTIA POST PROCEDURE. THE PATIENT NOTED THAT THE SHAPE WAS DIFFERENT, AND THE RIGHT IMPLANT FELT DIFFERENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2024-03202 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18909511 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTED EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A VIDEO CALL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18750599 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA IN-OFFICE, WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18430994 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA IN-OFFICE, WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18430993 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED DELAYED WOUND HEALING AND SKIN NECROSIS WITH INFECTION POST PROCEDURE. AS RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Impaired Healing; Necrosis

  MAUDE report 18378519 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND BILATERAL PSEUDOPTOSIS POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMHB635; SERIAL NUMBER (B)(6) THE LEFT SIDE, AND WITH CATALOG NUMBER SMHB635; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17719229 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND BILATERAL PSEUDOPTOSIS POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMHB635; SERIAL NUMBER (B)(6) THE LEFT SIDE, AND WITH CATALOG NUMBER SMHB635; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6), 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17719226 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 525CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT, WITH AN UNSPECIFIED MENTOR GEL IMPLANT, ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16950377 ↗