MENTOR MemoryGel Xtra Breast Implant SHPX180Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317025191), received between Jul 13, 2020 and Jul 29, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (3 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.

• InjuryJul 29, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 180CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III (LEFT-SIDED) AND II (RIGHT-SIDED) CAPSULAR CONTRACTURE DURING A FOLLOW-UP VISIT AS SHE WAS EXPERIENCING A PAINFUL LEFT BREAST, BILATERALLY BREAST DEFORMITY, ELEVATED BREASTS, AND MALPOSITION OF THE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22649683 ↗
• InjuryJul 29, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 180CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III (LEFT-SIDED) AND II (RIGHT-SIDED) CAPSULAR CONTRACTURE DURING A FOLLOW-UP VISIT AS SHE WAS EXPERIENCING A PAINFUL LEFT BREAST, BILATERALLY BREAST DEFORMITY, ELEVATED BREASTS, AND MALPOSITION OF THE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22649681 ↗
• InjuryNov 29, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 180CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST, BOTTOMING OUT OF THE LEFT BREAST, AND BILATERAL BREAST ASYMMETRY. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON DECEMBER 12, 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14089 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18231063 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYGEL, XTRA 180CC SILICONE BREAST PROSTHESIS, EXPERIENCED RIGHT SIDED ASYMMETRY ISSUE POST OPERATION. AS A RESULT, PATIENT UNDERWENT SECONDARY PROCEDURE ON (B)(6) 2020 TO CORRECT THE ISSUE OF ALIGNMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15668633 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A LEFT-SIDED 180CC MENTOR MEMORYGEL BREAST IMPLANT AND A RIGHT-SIDED 200CC MENTOR MEMORYGEL XTRA BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST AND BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 260CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12098 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 15588699 ↗
• InjuryJul 13, 2020Adverse 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 180CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS ACCOMPANIED BY FIRMNESS AND UPPER POLE DEFORMITIES, BOTH OF WHICH WERE MORE PRONOUNCED ON THE RIGHT SIDED. AS A RESULT, CAPSULECTOMY, MASTOPEXIES, AND REPLACEMENT WITH MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-08565 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10266811 ↗
• InjuryJul 13, 2020Adverse 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 180CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS ACCOMPANIED BY FIRMNESS AND UPPER POLE DEFORMITIES, BOTH OF WHICH WERE MORE PRONOUNCED ON THE RIGHT SIDED. AS A RESULT, CAPSULECTOMY, MASTOPEXIES, AND REPLACEMENT WITH MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-08564 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10266763 ↗