MENTOR MemoryGel Xtra Breast Implant SHPX595Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 00081317025337), received between Aug 5, 2019 and Jun 3, 2026 — classified as 132 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (39 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 138 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 25377227 ↗
• InjuryMay 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BREAST PAIN AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 25303231 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25260111 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 595CC 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 25129383 ↗
• MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY UTILIZING MENTOR MEMORYGEL, XTRA 595CC SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED UNKNOWN SIDED FOREIGN MATTER PREIMPLANTATION. THEY REPORTED THAT DURING THE SURGERY THERE APPEARED TO BE WHITE POWDER DUST ON THE IMPLANT ONCE OPENED, ANOTHER IMPLANT WAS USED AND PROCEDURE COMPLETED. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056970 ↗
• InjuryMar 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026, DUE TO A RUPTURED LEFT IMPLANT. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UPS WERE NOT PERFORMED AS NO REPORTER CONTACT INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24532732 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24446412 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24446408 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES IS ¿FEELING STIMULATION IN THE BREASTS LIKE SHE¿S BREASTFEEDING.¿ ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING ¿SAGGINESS¿ OF THE BREASTS. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Paresthesia

  MAUDE report 24172623 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES IS ¿FEELING STIMULATION IN THE BREASTS LIKE SHE¿S BREASTFEEDING.¿ ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING ¿SAGGINESS¿ OF THE BREASTS. 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 BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Paresthesia

  MAUDE report 24172617 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT'S OPERATIVE REPORTED STATED THERE WAS DOUBLE BUBBLE DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 535CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Wrinkling

  MAUDE report 23587269 ↗
• InjuryNov 17, 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 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED IMPAIRED HEALING ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Impaired Healing

  MAUDE report 23571105 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23369273 ↗
• InjuryJul 7, 2025Material 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 595CC GEL BREAST PROSTHESIS WAS DISSATISFIED WITH THE SIZE OF THE BREAST IMPLANT. THE PATIENT THOUGHT THE IMPLANT WAS TOO SMALL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection

  MAUDE report 22431613 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED IMPAIRED HEALING ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. THE EXACT DATE OF THIS EVENT IS UNKNOWN. THE PATIENT UNDERWENT DEVICE EXPLANTATION ON (B)(6) 2025,

  Patient problems: Impaired Healing

  MAUDE report 22142508 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV 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 22095618 ↗
• 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 21919682 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025,

  Patient problems: Capsular Contracture

  MAUDE report 21874571 ↗
• InjuryMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21549170 ↗
• InjuryMar 3, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST IMPLANT BOTTOMING OUT AND LATERALIZATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. DURING THE SURGERY, IT WAS DISCOVERED THAT THE RIGHT BREAST IMPLANT WAS RUPTURED. SUBSEQUENTLY, THE IMPLANTS WERE REPLACED WITH NON-MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21505129 ↗
• InjuryFeb 18, 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 595CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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 21402029 ↗
• InjuryNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT MENTIONS SHE GOES TO THE CHIROPRACTOR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20667910 ↗
• InjurySep 27, 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 PRIMARY BREAST AUGMENTATION PROCEDURE MENTOR MEMORYGEL XTRA BREAST IMPLANT 595CC GEL BREAST PROSTHESES DEVELOPED PAIN IN BOTH BREASTS POST IMPLANTATION. THE PAIN IN THE RIGHT BREAST SUBSIDED SHORTLY AFTER SURGERY BUT THE LEFT BREAST PAIN CONTINUED. ADDITIONALLY, THERE WAS A LACK OF SYMMETRY WITH THE RIGHT BREAST. IT WAS LATER DISCOVERED THAT THE LEFT BREAST PROSTHESIS HAD MOVED. AS A RESULT, THE PATIENT WAS SCHEDULED TO HAVE THE LEFT BREAST PROSTHESIS REPOSITIONED ON (B)(6) 2024. DURING THE SURGERY, IT WAS DISCOVERED THAT THE LEFT BREAST PROSTHESIS HAD RUPTURED. AS A RESULT, THE SURGEON DECIDED TO EXPLANT BOTH BREAST PROSTHESES AND REPLACE THEM WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-09863 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 20319076 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20306881 ↗
• InjurySep 9, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 595CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. ADDITIONALLY, THE PATIENT¿S LEFT BREAST PROSTHESIS BOTTOMED OUT POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-08262 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20170756 ↗