MENTOR MemoryGel Xtra Breast Implant THPX470Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317025733), received between Sep 12, 2019 and Nov 15, 2021 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 470CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS AND EXPERIENCED RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6)2021. THE PRODUCT CODE OF THE REPLACEMENT DEVICE IS EITHER SHPX465, SHPX490, RSZSHPX-465S, OR RSZSHPX490S. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2021 BASED ON AVAILABLE INFORMATION.

  Patient problems: Capsular Contracture

  MAUDE report 12817001 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 470CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED GRADE IV CAPSULAR CONTRACTURE AND BILATERAL PTOSIS POSTOPERATIVELY. DURING THE CONSULTATION HELD ON (B)(6) 2020, THE PATIENT'S PHYSICIAN STATED THAT THE RIGHT BREAST APPEARED TO BE HIGHER THAN THE LEFT SIDE, AND THE PATIENT EXPERIENCED RIGHT DOUBLE BUBBLE DEFORMITY AND DEVICE MIGRATION DUE TO THE CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL MASTOPEXY AND UNILATERAL REMOVAL AND REPLACEMENT WITH A 470CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (RIGHT CATALOG #: THPX470, RIGHT SERIAL #: (B)(4)) FOR THE RIGHT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11389107 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 470CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESES AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED GRADE IV CAPSULAR CONTRACTURE AND BILATERAL PTOSIS POSTOPERATIVELY. DURING THE CONSULTATION HELD ON (B)(6) 2020, THE PATIENT'S PHYSICIAN STATED THAT THE RIGHT BREAST APPEARED TO BE HIGHER THAN THE LEFT SIDE, AND THE PATIENT EXPERIENCED RIGHT DOUBLE BUBBLE DEFORMITY AND DEVICE MIGRATION DUE TO THE CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL MASTOPEXY AND UNILATERAL REMOVAL AND REPLACEMENT WITH A 470CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG #: THPX470, RIGHT SERIAL #: (B)(4)) ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11290187 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 470CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-00511889.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9007631 ↗