MENTOR MemoryGel Xtra Breast Implant SMPX440Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00081317025078), received between Jun 26, 2019 and Aug 14, 2026 — classified as 141 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 143 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation with a 440cc MENTOR MemoryGel Xtra Breast Implant on the right breast. Post-operatively, the patient developed right breast infection and right breast capsular contracture (baker grade IV). As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement device was a Mentor gel implant.

  Patient problems: Capsular Contracture; Post Operative Wound Infection

  MAUDE report 50255369 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  A female patient underwent primary breast augmentation with a MENTOR MemoryGel Xtra 440 cc silicone implant. She developed a right-sided capsular contracture that progressed to grade IV despite medical therapy. Consequently, on (b)(6) 2026, she underwent unilateral replacement with a right SMPX440 implant (catalog number 2144401-041).

  Patient problems: Capsular Contracture

  MAUDE report 50145327 ↗
• InjuryApr 29, 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 IV IN RIGHT BREAST). ON (B)(6) 2025, THE PATIENT UNDERWENT A PARTIAL CAPSULECTOMY OF THE RIGHT BREAST. THE DEVICE WAS NOTED TO BE INTACT. THE DEVICE WAS DISINFECTED AND REIMPLANTED. 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: Capsular Contracture

  MAUDE report 25035938 ↗
• InjuryApr 29, 2026Use of Device Problem; Adverse 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 IV IN RIGHT BREAST). ON (B)(6) 2025, THE PATIENT UNDERWENT A PARTIAL CAPSULECTOMY OF THE RIGHT BREAST. THE DEVICE WAS NOTED TO BE INTACT. THE DEVICE WAS DISINFECTED AND REIMPLANTED. 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: Capsular Contracture

  MAUDE report 25035928 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2026, AND REPLACED WITH 475CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24721523 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH 475CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24720218 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24683667 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24679700 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 440CC (SIDE A) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A 405CC (SIDE B) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE A SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24646217 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE 1ST OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Capsular Contracture

  MAUDE report 24645741 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24640181 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 400CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24621613 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 400CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 4 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24621611 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 23835131 ↗
• InjuryDec 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS FOUND TO BE RUPTURED. THE PATIENT ALSO REPORTEDLY UNDERWENT A FAT GRAFTING PROCEDURE SEVERAL MONTHS AFTER THE DEVICE WAS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23749817 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A BREAST MASS ON THE LEFT SIDE AND A REACTION 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: Local Reaction

  MAUDE report 23427397 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED A BREAST MASS ON THE LEFT SIDE AND A REACTION 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: Breast Mass

  MAUDE report 23427395 ↗
• InjuryOct 21, 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 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST RIPPLING. 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: Wrinkling

  MAUDE report 23350535 ↗
• InjuryOct 21, 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 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST RIPPLING. 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: Wrinkling

  MAUDE report 23350534 ↗
• InjuryAug 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 440CC GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2025. DURING EXPLANTATION, IT WAS OBSERVED THAT THE REMOVED RIGHT BREAST PROSTHESIS HAD RUPTURED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22709880 ↗
• InjuryApr 3, 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 IMPLANTATION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS 440 CC 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 SIMILAR DEVICES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21765754 ↗
• InjuryMar 31, 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 PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 440CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 440CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21733990 ↗
• InjuryMar 28, 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 RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 440CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 790CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED PAIN IN HER LEFT LATERAL CHEST AND A POORLY HEALED INCISION OF A RIGHT-SIDE VERTICAL DOG EAR POST IMPLANTATION. THE PATIENT ALSO SUFFERED FROM A BURN ON THE LEFT SIDE LATISSIMUS SKIN ISLAND AS WELL AS DISCOMFORT AND HYPERTROPHIC SCARRING ON THE RIGHT SIDE. THE PATIENT UNDERWENT A SURGERY TO REVISE THE SCARRING ON BOTH SIDES ON (B)(6) 2025. DURING THE PROCEDURE, AREAS OF FAT NECROSIS WERE REMOVED FROM THE RIGHT BREAST POCKET. THE RIGHT BREAST PROSTHESIS WAS DISCOVERED TO BE RUPTURED. THE SURGEON EXPLANTED THE RIGHT BREAST PROSTHESIS AND REPLACED IT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 790CC GEL BREAST PROSTHESIS. THE LEFT BREAST PROSTHESIS WAS NOT EXPLANTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21724503 ↗
• InjuryMar 14, 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 RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 440 CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA 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 21607473 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 440CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) 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 21526833 ↗