MENTOR MemoryGel Xtra Breast Implant THPX285Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317025665), received between Sep 1, 2020 and Sep 15, 2026 — classified as 11 injuries.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 285cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with bilateral Baker Grade II (left breast) and IV (right breast) Capsular Contracture by a medical professional. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6)2026.This report is for the left breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50774645 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 285cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with bilateral Baker Grade II (left breast) and IV (right breast) Capsular Contracture by a medical professional. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.This report is for the right breast prosthesis.

  Patient problems: Capsular Contracture

  MAUDE report 50774644 ↗
• InjuryMay 14, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2025, AND REPLACED WITH A 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25177189 ↗
• InjuryMar 13, 2026Adverse 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 GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24593384 ↗
• InjuryOct 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 REVISION PROCEDURE WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 285CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 285CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23439559 ↗
• InjuryJun 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 SURGERY WITH IMPLANTATION OF A 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED REMOVAL AND REPLACEMENT WITH A MENTOR GEL IMPLANT ON (B)(6) 2025. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 22285521 ↗
• InjuryMay 30, 2024Adverse 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 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED HIGH RIDING BREASTS WITH HARDNESS AND PAIN/TENDERNESS. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19424698 ↗
• InjuryMay 30, 2024Adverse 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 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED HIGH RIDING BREASTS WITH HARDNESS AND PAIN/TENDERNESS. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19424696 ↗
• InjuryApr 12, 2021Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 285C AND SUFFERED FROM A BILATERAL DEVICE MIGRATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11649025 ↗
• InjuryApr 12, 2021Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 285C AND SUFFERED FROM A BILATERAL DEVICE MIGRATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2021. THIS MEDWATCH IS FOR THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11649003 ↗
• InjurySep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 285CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available; Pain; Seroma

  MAUDE report 10478600 ↗