MENTOR MemoryGel Xtra Breast Implant SHPX650Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00081317025344), received between May 13, 2019 and Sep 30, 2026 — classified as 142 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (31 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 147 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50948540 ↗
• 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25260109 ↗
• InjuryMay 6, 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 IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Capsular Contracture

  MAUDE report 25107569 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE UTILIZING MENTOR MEMORYGEL, XTR 650CC SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE IV ON LEFT AND UNKNOWN GRADE ON THE RIGHT SIDE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST TOTAL CAPSULECTOMY, AND BILATERAL REPLACEMENTS PER FOLLOWING: L: (B)(6) / SHPB-740, R: (B)(6) / SHPB-740 ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 25035772 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III-IV). 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: Capsular Contracture

  MAUDE report 24904910 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III-IV). 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 24899100 ↗
• InjuryApr 15, 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 IV 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24886583 ↗
• InjuryApr 15, 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 IV 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 24886580 ↗
• InjuryApr 2, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24772646 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE WITH SOME ASYMMETRY DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24704736 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN UNSPECIFIED GEL BREAST PROSTHESIS AND EXPERIENCED AN INFECTION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24623545 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24397999 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24326857 ↗
• InjuryDec 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR GEL BREAST PROSTHESIS.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 23938586 ↗
• InjuryDec 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A FLIPPED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) , 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23846488 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, XTRA 650CC ON THE LEFT AND 700CC ON THE RIGHT SIDE, SILICONE PROSTHESIS EXPERIENCE BILATERAL CAPSULAR CONTRACTURE GRADE IV POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2026. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 23707746 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, XTRA 650CC SILICONE PROSTHESIS EXPERIENCE BILATERAL CAPSULAR CONTRACTURE GRADE IV POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REMOVAL SURGERY ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 23707588 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 650CC GEL BREAST PROSTHESIS WHEN THE RIGHT BREAST PROSTHESIS DID NOT DROP AND SETTLE PROPERLY POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT A CORRECTION SURGERY IN (B)(6) 2025. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23639789 ↗
• InjurySep 12, 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 650CC 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 SURGERY ON (B)(6) , 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23043382 ↗
• InjuryAug 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22751593 ↗
• InjuryAug 6, 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 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED HYPERSENSITIVITY ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22729005 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22728645 ↗
• InjuryJun 9, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. DURING THE SURGERY, THE EXPLANTED DEVICES WERE OBSERVED WITH A GREASY RESIDUE COATING THEM. THE SURGEON WAS UNSURE IF THE DEVICES WERE RUPTURED. NO FURTHER INFORMATION WAS PROVIDED. SEVERAL 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172450 ↗
• InjuryJun 9, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. DURING THE SURGERY, THE EXPLANTED DEVICES WERE OBSERVED WITH A GREASY RESIDUE COATING THEM. THE SURGEON WAS UNSURE IF THE DEVICES WERE RUPTURED. NO FURTHER INFORMATION WAS PROVIDED. SEVERAL 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172449 ↗
• InjuryMay 29, 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 SURGERY WITH IMPLANTATION OF A 650CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III-IV DURING A PHYSICAL EXAM AS SHE WAS EXPERIENCING A FIRM, HARD, ELEVATED, AND DISTORTED LEFT BREAST. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22109169 ↗