MENTOR MemoryShape Breast Implant 3341457Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317004981), received between Nov 10, 2022 and Feb 28, 2023 — 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.

• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: 982-023). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 515CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE POST-OPERATIVELY. ON (B)(6) 2018, SHE PRESENTED WITH WRINKLING, STEP OFF RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: Wrinkling

  MAUDE report 16452537 ↗
• InjuryNov 10, 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 AN BREAST AUGMENTATION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC ON THE LEFT, AND MENTOR MEMORYSHAPE 515CC SILICONE BREAST IMPLANT ON THE RIGHT SIDE HAS EXPERIENCED BILATERAL BREAST PAIN POSTOPERATIVE. PATIENT HAS NOT YET BEEN INTO OFFICE FOR EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHTPROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15771885 ↗