MENTOR MemoryGel Xtra Breast Implant SHPX260Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00081317025221), received between Jul 3, 2019 and Aug 25, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse 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 gel breast prostheses developed capsular contracture in both breasts post implantation (Baker Grade III in left breast, Baker Grade IU in right breast). Bilateral capsular contracture was diagnosed via a healthcare professional¿s exam. As a result, the patient is scheduled to undergo explantation.This MedWatch report is for the patient¿s right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50438930 ↗
• InjuryAug 25, 2026Adverse 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 gel breast prostheses developed capsular contracture in both breasts post implantation (Baker Grade III in left breast, Baker Grade IU in right breast). Bilateral capsular contracture was diagnosed via a healthcare professional¿s exam. As a result, the patient is scheduled to undergo explantation.This MedWatch report is for the patient¿s left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50438924 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED UNKNOWN SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25411303 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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 24581797 ↗
• InjuryNov 27, 2025Adverse 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 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT 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 23668517 ↗
• InjuryJul 9, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22459640 ↗
• InjuryJun 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM AND A POSSIBLY RUPTURED RIGHT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL RIGHT-SIDED REMOVAL AND REPLACEMENT WITH A MENTOR GEL IMPLANT ON (B)(6) 2025. THE EXPLANTED DEVICE WAS INSPECTED AND DESCRIBED AS NOT RUPTURED; HOWEVER, THEY WERE NOT ENTIRELY SURE.

  Patient problems: Capsular Contracture

  MAUDE report 22342216 ↗
• InjuryFeb 12, 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 260CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21365217 ↗
• InjuryAug 14, 2024Adverse 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 260CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: Capsular Contracture

  MAUDE report 19982790 ↗
• InjuryAug 14, 2024Adverse 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 WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 260CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: Capsular Contracture

  MAUDE report 19982788 ↗
• MalfunctionJun 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED IN A BREAST AUGMENTATION WAS RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561412 ↗
• InjuryJun 7, 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 PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 260CC GEL BREAST PROSTHESIS DEVELOPED A HEMATOMA IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 19484698 ↗
• InjuryMar 11, 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 AUGMENTATION PROCEDURE WITH A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER SMPX270; SERIAL NUMBER (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18876474 ↗
• InjuryFeb 2, 2024Adverse 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 A BREAST AUGMENTATION REVISION WITH A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHONE CALL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18634702 ↗
• InjuryNov 29, 2023Adverse 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 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST, BOTTOMING OUT OF THE LEFT BREAST, AND BILATERAL BREAST ASYMMETRY. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14091 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 18231060 ↗
• InjuryOct 25, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (LEFT) AND A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (RIGHT) EXPERIENCED A LACTATION DISORDER BILATERAL POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY. SEE 1645337-2023-12680 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Unspecified Reproductive System or Breast Problem

  MAUDE report 18007300 ↗
• InjuryOct 25, 2023Adverse 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 A 200CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (LEFT) AND A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (RIGHT) EXPERIENCED A LACTATION DISORDER BILATERAL POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY. SEE 1645337-2023-12680 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 18007158 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 260CC 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 SIMILAR DEVICES ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 17082795 ↗
• InjuryMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED THE RIGHT BREAST APPEARED DROOPY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023. HOWEVER, DURING THE SURGERY, A RUPTURED RIGHT BREAST IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16853407 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 16269289 ↗
• InjuryDec 8, 2022Adverse 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 SURGERY WITH A 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. TWO DEVICE SERIAL NUMBERS (B)(4), HAVE BEEN DOCUMENTED, HOWEVER, IT IS UNKNOWN WHICH SERIAL NUMBER BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 15946241 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15847479 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-13463 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 15749768 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-13464 FOR CONTRALATERAL PROTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 15749524 ↗
• InjuryAug 11, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A AFRICAN AMERICAN FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL, 560CC ON THE LEFT, AND 260CC ON THE RIGHT SIDE SILICONE BREAST IMPLANT EXPERIENCED BILATERAL SILENT RUPTURE POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L) CAT#:9583050, SN#: (B)(4), R) CAT#:7505373; SN: (B)(4) ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15213705 ↗