MENTOR MemoryShape Breast Implant 3341154Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317024217), received between Mar 25, 2020 and Mar 31, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III/IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24743342 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III/IV POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24743337 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 380CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WAS VERY DISSATISFIED WITH HOW CLOSELY HER BREASTS MATCHED ONE ANOTHER. ADDITIONALLY, THE PATIENT DEVELOPED RIPPLING (WRINKLING) IN BOTH BREASTS. 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; Wrinkling

  MAUDE report 22591678 ↗
• InjuryFeb 19, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 380CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL DEVICE MIGRATIONS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21412569 ↗
• InjuryFeb 19, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 380CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL DEVICE MIGRATIONS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21412568 ↗
• InjuryMay 3, 2024Adverse 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: (B)(6)). IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 380CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT WAS ASKED TO SEE THEIR HEALTHCARE PROVIDER BUT WHEN TO THE EMERGENCY ROOM INSTEAD. ALL LABS RESULTS, INCLUDING XRAY AND AN ULTRA SOUND, WERE NORMAL. THE PATIENT COMPLAINED ABOUT PAIN AND TIGHTNESS ON THE RIGHT SIDE. IT WAS REPORTED THAT THE PATIENT RAN OUT OF FLEXERIL. THE MUSCLE PAIN WAS RESOLVED ON (B)(6) 2020. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, NON-SERIOUS, AND DEFINITE RELATIONSHIP TO THE DEVICE. 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

  MAUDE report 19243032 ↗
• InjuryMay 18, 2022Adverse 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 UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 380CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL EARLY ONSET SEROMA POST-OPERATIVELY. THE PATIENT REPORTED THAT HER BODY WAS REJECTING THE BREAST PROSTHESES AND THAT YELLOW FLUID WAS POURING OUT OF THE BODY. THE PATIENT HAD TO GO TO THE HOSPITAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022 ON THE RIGHT AND EXPLANTATION ON (B)(6) 2022 ON THE LEFT. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Seroma

  MAUDE report 14430952 ↗
• InjuryMay 18, 2022Adverse 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 UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 380CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL EARLY ONSET SEROMA POST-OPERATIVELY. THE PATIENT REPORTED THAT HER BODY WAS REJECTING THE BREAST PROSTHESES AND THAT YELLOW FLUID WAS POURING OUT OF THE BODY. THE PATIENT HAD TO GO TO THE HOSPITAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON APRIL 01, 2022 ON THE RIGHT AND EXPLANTATION ON (B)(6) 2022 ON THE LEFT. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Seroma

  MAUDE report 14430740 ↗
• InjuryApr 28, 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 PRIMARY BREAST AUGMENTATION WITH 380CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED AUTOIMMUNE DISORDER SYMPTOMS INCLUDING LUPUS, HAIR LOSS, SKIN RASHES, TIRED, MEMORY CONFUSION, ANXIETY, DEPRESSION, HEADACHES, BLURRY VISION, AND DRY SKIN POSTOPERATIVELY. 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-SIDED DEVICE.

  Patient problems: Autoimmune Disorder

  MAUDE report 11737385 ↗
• InjuryApr 28, 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 PRIMARY BREAST AUGMENTATION WITH 380CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED AUTOIMMUNE DISORDER SYMPTOMS INCLUDING LUPUS, HAIR LOSS, SKIN RASHES, TIRED, MEMORY CONFUSION, ANXIETY, DEPRESSION, HEADACHES, BLURRY VISION, AND DRY SKIN POSTOPERATIVELY. 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-SIDED DEVICE.

  Patient problems: Autoimmune Disorder

  MAUDE report 11737340 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 380CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE RIGHT SIDE INTRAOPERATIVELY. THE IMPLANT WAS NOT PUT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9881713 ↗