MENTOR MemoryShape Breast Implant 3341257Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317004943), received between Dec 27, 2019 and May 1, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2024Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. ADDITIONALLY, IT WAS REPORTED THAT THERE IS POSSIBLE BILATERAL RUPTURE OF THE PATIENT¿S BREAST PROSTHESES DUE TO ¿PHYSICAL ABUSE TRAUMA¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-04267 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19221750 ↗
• InjuryApr 9, 2024Gel Leak; Material Rupture; Adverse Event Without Identified Device or Use Problem; Gel Leak; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19074479 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE, 330CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED GRANULOMA AND BILATERAL BREAST PAIN POSTOPERATIVELY. THE ULTRASOUND EXAMINATION CONFIRMED RIGHT SIDED GRANULOMA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAPSULECTOMY AND BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT: SMPX-405, SN: (B)(6), R/ CAT: SMPX-350, SN: (B)(6) ON (B)(6), 2023. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18284624 ↗
• InjuryOct 18, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE, 330CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POSTOPERATIVELY. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Granuloma

  MAUDE report 17962006 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW STUDY# (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT SIDE, AND WITH 370CC MENTOR MEMORYSHAPE BREAST IMPLANT ON RIGHT SIDE ON (B)(6) 2015, AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 10931080 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 9527120 ↗