MENTOR MemoryGel Xtra Breast Implant SMHX700Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10081317027925), received between Oct 6, 2021 and Aug 18, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. 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.

  Patient problems: Capsular Contracture

  MAUDE report 22826357 ↗
• InjuryNov 8, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC (LEFT) AND A 630CC (RIGHT) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE AND MALPOSITION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20644407 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH AN EARLY ONSET SEROMA OF THE LEFT BREAST BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022.

  Patient problems: Pocket Erosion; Post Operative Wound Infection; Seroma

  MAUDE report 16938634 ↗
• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT WAS FOUND TO BE RUPTURED WHEN IT WAS REMOVED FROM THE BOX. NO ADVERSE EVENT NOR ANY PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288773 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL 700CC, SILICONE BREAST IMPLANT EXPERIENCED RIGHT-IMPLANT HEMATOMA, AND WOUND INFECTION POST PROCEDURE. THE PATIENT EXPERIENCED RIGHT BREAST INFECTION AND HEMATOMA, INCREASED TIGHTNESS, AND PAIN. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022.

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 14279335 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO HAD 700CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE, RIGHT SIDED IMPLANT EXPOSURE, AND THE PRESENCE OF A HYPERTROPHIC SCAR POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2021-11187 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Pocket Erosion

  MAUDE report 12587305 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO HAD 700CC MENTOR MEMORYGEL BREAST IMPLANTS PLACED EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE, RIGHT SIDED IMPLANT EXPOSURE, AND THE PRESENCE OF A HYPERTROPHIC SCAR POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2021-11188 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Scar Tissue

  MAUDE report 12587270 ↗