MENTOR MemoryShape Breast Implant 3341107Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317004912), received between Aug 22, 2022 and Mar 1, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (1 report).

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.

• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SYMPTOMS INCLUDING ARTHRITIS, PAIN, DRY EYES, DRY MOUTH POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18818303 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SYMPTOMS INCLUDING ARTHRITIS, PAIN, DRY EYES, DRY MOUTH POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Autoimmune Disorder

  MAUDE report 18818298 ↗
• InjuryMay 26, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A 52-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON MAY 3, 2023. UPON REMOVAL, THERE WAS BLACK DOTS ON THE IMPLANT AND THEY WERE SUSPICIOUS OF MOLD. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING: (LEFT) 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB340 LOT: 9770626 SN: (B)(6) AND (RIGHT) 340CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB340 LOT: 9860600 SN: (B)(6).

  Patient problems: Capsular Contracture

  MAUDE report 17015287 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BREAST MASSES, AND IMPLANT SITE FLUID COLLECTION BILATERALLY POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Mass; Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849560 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BREAST MASSES, AND IMPLANT SITE FLUID COLLECTION BILATERALLY POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Mass; Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847210 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 225CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III (L) AND BAKER GRADE UNKNOWN (R) POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15266888 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 225CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III (L) AND BAKER GRADE UNKNOWN (R) POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15266879 ↗