MENTOR MemoryShape Breast Implant 3341455Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317005377), received between May 10, 2019 and Aug 24, 2026 — classified as 13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a breast augmentation revision procedure with a MENTOR MemoryShape Breast Implant gel breast prosthesis developed Baker Grade III capsular contracture in her right breast post implantation. The capsular contracture was diagnosed via a physical exam. As a result, the patient is scheduled to undergo explantation.

  Patient problems: Capsular Contracture

  MAUDE report 50418398 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; 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 585CC GEL BREAST PROSTHESIS DEVELOPED PAIN IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT NOTICED A LARGE LUMP ON HER LEFT BREAST AND IT WAS REPORTED THAT IT IS GETTING LARGER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 17742561 ↗
• InjuryJul 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASOUND AND COMPUTERIZED TOMOGRAPHY SCAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 545CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17397648 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED PAIN, WEIGHT LOSS POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15774849 ↗
• InjuryJan 6, 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 RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE 585CC SILICONE PROSTHESIS EXPERIENCED BILATERAL DISCOMFORT AND LEFT SIDED RUPTURE POST PROCEDURE. THE MRI EXAMINATION CONFIRMED INTRACAPSULAR RUPTURE OF THE LEFT BREAST IMPLANT, AND INTACT RIGHT BREAST IMPLANT WITH STABLE TRACE PERI-IMPLANT FLUID. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH MENTOR SILICONE IMPLANTS ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11127758 ↗
• InjuryJan 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY WITH A MENTOR MEMORYSHAPE 585CC SILICONE PROSTHESIS EXPERIENCED BILATERAL DISCOMFORT AND LEFT SIDED RUPTURE POST PROCEDURE. THE MRI EXAMINATION CONFIRMED INTRACAPSULAR RUPTURE OF THE LEFT BREAST IMPLANT, AND INTACT RIGHT BREAST IMPLANT WITH STABLE TRACE PERI-IMPLANT FLUID. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH MENTOR SILICONE IMPLANTS ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11127733 ↗
• InjuryDec 23, 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 BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 585CC AND EXPERIENCED SEROMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS (SERIAL NUMBERS (B)(4)) ON (B)(6) 2017.

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 11068816 ↗
• InjuryDec 23, 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 BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 585CC AND EXPERIENCED SEROMA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2016.

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 11068769 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE UNITED STATES THAT A FEMALE PATIENT OF AN UNKNOWN AGE AND ETHNICITY WHO HAD A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT PLACED WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL LYMPHOMA OF THE RIGHT BREAST ON AN UNKNOWN DATE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE DEVICE ON (B)(6) 2020. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN MORE IN-DEPTH INFORMATION ON THE SPECIFIC DETAILS OF THIS EVENT, NO ADDITIONAL EVENT DETAILS HAVE BEEN MADE AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL EVENT DETAILS ARE MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Anaplastic Large Cell Lymphoma; No Code Available; Seroma

  MAUDE report 10687794 ↗
• InjuryJun 2, 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 FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 585 CC AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT WOULD UNDERGO EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10110633 ↗
• InjuryJul 22, 2019Adverse 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 WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE RIGHT SIDE, SUFFERED EXTREME TIGHTNESS, LOTS OF PRESSURE, SHARP PAIN UNDERNEATH THE IMPLANT POST-OPERATIVELY. THE PATIENT EXPRESSED THAT THEY FELT LIKE SOMEONE WAS STANDING ON THEIR CHEST FOR FOUR YEARS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 8812727 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN, WHITE & NATIVE AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT. THE PATIENT REPORTED LEFT SIDE DISFIGURED CHEST AND UNCOMFORTABLE FEELING. ON (B)(6) 2016, ULTRASOUND WAS PERFORMED. THE PHYSICIAN STATED THAT THE IMPLANT WAS COMPLETELY RUPTURED. BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN WAS ALSO FOUND. AS A RESULT, PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT ON (B)(6) 2019 WITH CATALOG NUMBER SHPX700; SERIAL NUMBER (B)(4) ON THE LEFT SIDE AND CATALOG NUMBER SHPX700; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8711578 ↗
• InjuryMay 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN, WHITE & NATIVE AMERICAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 585CC MENTOR MEMORYSHAPE BREAST IMPLANT. THE PATIENT REPORTED LEFT SIDE DISFIGURED CHEST AND UNCOMFORTABLE FEELING. ON (B)(6) 2016, ULTRASOUND WAS PERFORMED. THE PHYSICIAN STATED THAT THE IMPLANT WAS COMPLETELY RUPTURED. AS A RESULT, PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT ON (B)(6) 2019 WITH CATALOG NUMBER SHPX700 ; SERIAL NUMBER (B)(4) ON THE LEFT SIDE AND CATALOG NUMBER SHPX700; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8600921 ↗