MENTOR MemoryShape Breast Implant 3341059Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317005049), received between Feb 10, 2020 and Nov 4, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23472127 ↗
• InjurySep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 235CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. RUPTURE WAS DIAGNOSED VIA MRI. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20208285 ↗
• InjurySep 12, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 235CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. RUPTURE WAS DIAGNOSED VIA MRI. 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.

  Patient problems: Breast Mass; Deformity/ Disfigurement

  MAUDE report 20207992 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 225CC (LEFT) AND 235CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING NON-RHEUMATOLOGIC DEGENERATIVE ARTHRITIS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232178 ↗
• InjuryJan 22, 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 235CC AND SUFFERED FROM A CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND BAKER GRADE II ON THE RIGHT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture; Wrinkling

  MAUDE report 11212381 ↗
• InjuryJan 22, 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 235CC AND SUFFERED FROM A CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND BAKER GRADE II ON THE RIGHT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2021. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 11212338 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 235CC MENTOR MEMORYSHAPE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE BILATERAL LATE-ONSET SEROMA, AND UNEXPLAINED SYSTEMIC SYMPTOMS OF HAIR LOSS AND LUMPS ON BREAST AND ARMPITS. PATIENT REPORTED EXPERIENCING LOTS OF FLUID AND SWELLING. HER RIGHT SIDE IS SWOLLEN AND PAINFUL. HER LEFT SIDE INCREASED IN SIZE AND HOT TO THE TOUCH. SHE HAS CONSULTED A MEDICAL PROFESSIONAL AND WAS ADVISED TO HAVE THE IMPLANTS REMOVED AND THE FLUID TESTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available; Seroma

  MAUDE report 9685459 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 235CC MENTOR MEMORYSHAPE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE BILATERAL LATE-ONSET SEROMA, AND UNEXPLAINED SYSTEMIC SYMPTOMS OF HAIR LOSS AND LUMPS ON BREAST AND ARMPITS. PATIENT REPORTED EXPERIENCING LOTS OF FLUID AND SWELLING. HER RIGHT SIDE IS SWOLLEN AND PAINFUL. HER LEFT SIDE INCREASED IN SIZE AND HOT TO THE TOUCH. SHE HAS CONSULTED A MEDICAL PROFESSIONAL AND WAS ADVISED TO HAVE THE IMPLANTS REMOVED AND THE FLUID TESTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: No Code Available; Seroma

  MAUDE report 9685455 ↗