MENTOR MemoryShape Breast Implant 3341207Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317004936), received between Jul 27, 2020 and Feb 29, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAFETY_NOTE] SUBJECT ID:(B)(6) THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2016. ADVERSE EVENT # 1. LUMP MEDIAL LEFT BREAST, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: (B)(6 )2016. ON (B)(6) 2018, SHE PRESENTED WITH LUMP MEDIAL LEFT BREAST. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, NOT RELATED TO THE DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: Breast Mass

  MAUDE report 18807993 ↗
• InjuryAug 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 290CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 THE LEFT SIDE AND AN IMPLANT SITE HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. THE HEMATOMA REQUIRED SURGICAL INTERVENTION TO ASPIRATE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Hematoma

  MAUDE report 12374128 ↗
• InjuryJun 30, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 290CC MENTOR MEMORYSHAPE SILICONE BREAST PROSTHESIS EXPERIENCED BILATERAL BAKER¿S GRADE UNKNOWN CAPSULAR CONTRACTURE POST PROCEDURE. TH ISSUE WAS DIAGNOSED THROUGH PATIENTS¿ SYMPTOMS. AS A RESULT, THE PATIENT SCHEDULE FOR BILATERAL REPLACEMENTS ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 12096949 ↗
• InjuryJun 30, 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 WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 290CC MENTOR MEMORYSHAPE SILICONE BREAST PROSTHESIS EXPERIENCED BILATERAL BAKER¿S GRADE UNKNOWN CAPSULAR CONTRACTURE POST PROCEDURE. TH ISSUE WAS DIAGNOSED THROUGH PATIENTS¿ SYMPTOMS. AS A RESULT, THE PATIENT SCHEDULE FOR BILATERAL REPLACEMENTS ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 12096855 ↗
• InjuryJul 27, 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 PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 290CC AND EXPERIENCE CAPSULAR CONTRACTURE, BAKER GRADE 3 THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10330612 ↗