MENTOR MemoryShape Breast Implant 3341005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317005285), received between May 6, 2021 and May 31, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 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 WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 195CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE POSTOPERATIVELY, BAKER GRADE UNKNOWN. THE PATIENT REPORTED THAT THE LEFT BREAST IS HARD, AND THAT SHE HAS CONSULTED WITH A MEDICAL 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 11906144 ↗
• InjuryMay 6, 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 BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 195CC (L) AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (R). THE PATIENT UNDERWENT PROPHYLACTIC REMOVAL OF THE BREAST IMPLANTS ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784709 ↗