MENTOR MemoryGel Xtra Breast Implant SMPX645Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00081317025153), received between Aug 27, 2019 and Sep 18, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Breast Cancer; Capsular Contracture

  MAUDE report 50829255 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT IMPLANT WHICH WAS IDENTIFIED USING MAGNETIC RESONANCE IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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: Deformity/ Disfigurement

  MAUDE report 24747991 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 645CC 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) 2025. THE REPLACEMENT DEVICES WERE TWO NON-MENTOR DEVICES. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23708936 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 645CC 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) 2025. THE REPLACEMENT DEVICES WERE TWO NON-MENTOR DEVICES. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23708935 ↗
• InjuryApr 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED SWOLLEN LYMPH NODES ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 21752861 ↗
• InjuryMar 26, 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 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Pocket Erosion; Post Operative Wound Infection; Seroma

  MAUDE report 21699122 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL XTRA, 645CC SILICONE PROSTHESIS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL CAPSULOTOMY AND BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT:SMPX-645, LEFT SN (B)(6), RIGHT CAT:SMPX-645 SN (B)(6), ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 20506895 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 30-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20427163 ↗
• InjurySep 18, 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 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3-4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20248324 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 645CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. 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 20207876 ↗
• InjuryMar 23, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL XTRA, 645CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18965211 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST, SUFFERED RIGHT BREAST THAT HAS GOTTEN LARGER, FIRMER AND SORE, POST-OPERATIVELY. THE PATIENT WAS GIVEN AN UNSPECIFIED MEDICATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15432363 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15380937 ↗
• InjuryApr 20, 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 UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 645 CCC SILICONE BREAST IMPLANT HAS EXPERIENCED BILATERAL BREAST PAIN, AND SKIN REACTION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE ONE OF THE TWO PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Skin Inflammation/ Irritation

  MAUDE report 14161513 ↗
• InjuryApr 20, 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 UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL 645 CCC SILICONE BREAST IMPLANT HAS EXPERIENCED BILATERAL BREAST PAIN, AND SKIN REACTION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE ONE OF THE TWO PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Skin Inflammation/ Irritation

  MAUDE report 14161467 ↗
• InjuryMar 25, 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 UNDERWENT BREAST RECONSTRUCTION WITH A (RIGHT) 800CC MENTOR MEMORYGEL BREAST IMPLANT AND A (LEFT) 645CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST DEFORMITIES AND LEFT BREAST SENSORY NEUROMA. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT SURGERY ON (B)(6), 2022. DURING SURGERY, IT WAS DISCOVERED THAT THE RIGHT BREAST IMPLANT WAS RUPTURED. SUBSEQUENTLY, BOTH IMPLANTS WERE REPLACED WITH THE FOLLOWING: (RIGHT) 500CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE CATALOG: SDC135H LOT: 9587144 SN: (B)(4) AND (LEFT) 500CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE CATALOG: SDC135H LOT: 9632963 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 13911874 ↗
• InjuryAug 25, 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 AUGMENTATION WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED GRADE IV CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG #: SMPX645, RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021. THE PATIENT¿S SYMPTOMS WERE IMPROVED AFTER THE REVISION SURGERY.

  Patient problems: Capsular Contracture

  MAUDE report 12368674 ↗
• InjuryApr 23, 2021Adverse 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 UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED UNSPECIFIED COMPLICATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT SIDE DEVICE. THE PATIENT UNDERWENT INTERVENTION FOR CAPSULAR CONTRACTURE PRIOR TO EXPLANTATION, WHICH FOR THE LEFT SIDE DEVICE WAS CAPTURED UNDER MANUFACTURER REPORT NUMBER 1645337-2021-04398.

  Patient problems: Insufficient Information

  MAUDE report 11720442 ↗
• InjuryApr 23, 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED UNSPECIFIED COMPLICATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT SIDE DEVICE. THE PATIENT UNDERWENT INTERVENTION FOR CAPSULAR CONTRACTURE PRIOR TO EXPLANTATION, WHICH FOR THE LEFT SIDE DEVICE WAS CAPTURED UNDER MANUFACTURER REPORT NUMBER 1645337-2021-04399.

  Patient problems: Insufficient Information

  MAUDE report 11720428 ↗
• InjuryApr 23, 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 CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. PATIENT REPORTED DEFORMATION IN BOTH BREASTS, AND STATED THEY WERE VERY PAINFUL. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 11712857 ↗
• InjuryApr 23, 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 CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 645CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. PATIENT REPORTED DEFORMATION IN BOTH BREASTS, AND STATED THEY WERE VERY PAINFUL. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 11712850 ↗
• InjuryDec 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 645CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT-SIDED IMPLANT RUPTURE POSTOPERATIVELY. RUPTURE WAS CONFIRMED BY CT SCAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2020.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11069999 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 645CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED RIGHT BREAST CANCER POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. DURING THE EXPLANTATION SURGERY, THE LEFT BREAST IMPLANT WAS DISCOVERED TO HAVE RUPTURED. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cancer; No Code Available

  MAUDE report 10830566 ↗
• InjuryNov 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT, WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 645CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED RIGHT BREAST CANCER POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. DURING THE EXPLANTATION SURGERY, THE LEFT BREAST IMPLANT WAS DISCOVERED TO HAVE RUPTURED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 10830525 ↗
• InjuryOct 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 645CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT IS PLANNED FOR (B)(6) 2020. SEE 1645337-2020-13810 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement; No Code Available

  MAUDE report 10751924 ↗