MENTOR MemoryGel Xtra Breast Implant SHPX700Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00081317025351), received between Jun 24, 2019 and Apr 9, 2026 — classified as 124 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (33 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 126 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 24835420 ↗
• InjuryMar 10, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL DEVICE MIGRATION ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24559940 ↗
• InjuryMar 4, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT), COMPLICATED BY BILATERAL BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24510537 ↗
• InjuryMar 4, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT), COMPLICATED BY BILATERAL BREAST IMPLANT MALPOSITION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24504271 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 24391522 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL PTOSIS AND CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24325105 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT REPORTED TWO DEVICE SERIAL NUMBERS, 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 24259451 ↗
• InjuryJan 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Capsular Contracture

  MAUDE report 23985491 ↗
• InjuryDec 31, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) , 2025. DURING REMOVAL, THE IMPLANT WAS IDENTIFIED TO HAVE A MILKY COLOR. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23936894 ↗
• InjuryDec 16, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23821161 ↗
• InjuryDec 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 PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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: Capsular Contracture

  MAUDE report 23792959 ↗
• InjuryOct 20, 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 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 23341340 ↗
• InjuryOct 16, 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 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND RIGHT BREAST INFECTION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23311533 ↗
• InjurySep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. 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 23089011 ↗
• InjuryJul 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED DEVICE EXTRUSION AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO MENTIONED THAT THE PATIENT HAD BREAST PAIN AND HARDNESS AFTER THE INITIAL IMPLANTION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SHPX595) WITH SERIAL NUMBER (B)(6).

  Patient problems: Pocket Erosion

  MAUDE report 22485366 ↗
• InjuryJun 10, 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 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED 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 22173785 ↗
• InjuryApr 28, 2025Material Rupture; Material Rupture

  HCP REPORT SOURCE: WAS YOUR PATIENT IMPLANTED IN THE UNITED STATES? YES. WHAT IS YOUR PATIENT EXPERIENCING? RUPTURE. WHICH SIDE IS THIS HAPPENING ON? BILATERAL. IF DEFLATION/RUPTURE WAS EVENT SPONTANEOUS OR DID YOU EXPERIENCE ANY TRAUMA? NO TRAUMA ANY PRE-OP SCANS AVAILABLE? NO. IF CAPSULAR CONTRACTURE, WHAT IS THE BAKER GRADE? N/A. DOES YOUR PATIENT HAVE PRIOR HISTORY OF CAPSULAR CONTRACTURE? N/A. WAS A SHARP INSTRUMENT USED DURING THE REMOVAL OF THE DEVICES? UNKNOWN. HAVE YOU CONSULTED WITH YOUR PATIENT? YES. HOW WAS THE MATTER DIAGNOSED? DURING SURGERY. IMPLANT INFORMATION: LEFT CATALOG NUMBER: SHPX595. LEFT SERIAL NUMBER: (B)(6). RIGHT CATALOG NUMBER: SHPX700. RIGHT SERIAL NUMBER: (B)(6). ARE THE DEVICES SMOOTH OR TEXTURED? SMOOTH. DID PATIENT HAVE IMPLANT REPLACEMENTS: YES. WAS PATIENT REPLACED WITH MENTOR GEL? YES. IF IMPLANTS REMOVED, DID THE SYMPTOMS IMPROVE? UNKNOWN AT THIS TIME. NEW DEVICES INFORMATION: LEFT CATALOG NUMBER: SHPB685. LEFT SERIAL NUMBER: (B)(6). RIGHT CATALOG NUMBER: SHPB775. RIGHT SERIAL NUMBER: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21919690 ↗
• InjuryMar 26, 2025Adverse 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 A MENTOR MEMORYGEL XTRA BREAST IMPLANT 700CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S 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 21700934 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE, AND WITH 755CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. 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. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21474620 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION USING MENTOR MEMORYGEL XTRA 700CC SILICONE PROSTHESIS EXPERIENCED A LEFT-SIDED SILENT RUPTURE, AND RIGHT SIDED WRINKLING AFTER IMPLANTATION. THIS COMPLICATION WAS IDENTIFIED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH REPLACEMENT OF LEFT BREAST IMPLANT WITH SERIAL # (B)(6), AND DERMAL FILLER TO RIGHT BREAST CONTOUR IRREGULARITY ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Wrinkling

  MAUDE report 21423188 ↗
• InjuryFeb 6, 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 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG: SHPX700, LOT: 9984148, SN: (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 21328910 ↗
• InjuryJan 23, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA700CC SILICONE PROSTHESIS EXPERIENCED A RIGHT-SIDED DEVICE SILENT RUPTURE FOLLOWING IMPLANTATION. THIS COMPLICATION WAS CONFIRMED THROUGH A CT EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION REGARDING THE EXPLANTATION OR AN ANTICIPATED EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21219798 ↗
• InjuryJan 22, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION USING MENTOR MEMORYGEL XTRA 700CC SILICONE PROSTHESIS EXPERIENCED A LEFT-SIDED SILENT RUPTURE AFTER IMPLANTATION. THIS COMPLICATION WAS IDENTIFIED THROUGH A THOROUGH PHYSICAL EXAMINATION. SUBSEQUENTLY, THE PATIENT WAS ADVISED TO UNDERGO BILATERAL REPLACEMENTS, WHICH WERE PERFORMED USING CAT: SHPX700 ON (B)(6) 2025, TO ADDRESS THE RUPTURE AND RESTORE THE DESIRED AESTHETIC OUTCOMES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21208945 ↗
• InjuryDec 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 700CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 700CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20857831 ↗
• InjuryNov 12, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 45-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED A RUPTURE AND IMPLANT MALPOSITION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SHPX700) WITH SERIAL NUMBER (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20670014 ↗