MENTOR MemoryShape Breast Implant 3541108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317005438), received between Oct 18, 2019 and Sep 19, 2025 — classified as 7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 215CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT DURING A PHYSICAL EXAM AND CONFIRMED USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23096921 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 215CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT NOTED A FOLD IN THE RIGHT BREAST IMPLANT. SUBSEQUENTLY, SHE EXPERIENCED RIGHT BREAST PAIN/DISCOMFORT, RIGHT BREAST BUMPS, BREAST LYMPHADENOPATHIES, BREAST IMPLANT ILLNESS, HOT FLASHES, HEADACHES, FATIGUE, INSOMNIA, AND IRRITABILITY. AFTERWARDS, SHE WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT ACCOMPANIED BY ABNORMAL BREAST LYMPH NODES USING MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. ADDITIONALLY, SHE HAD A HEMANGIOPERICYTOMA THAT WAS SURGICALLY REMOVED AND RADIATED IN 2022. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08459 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 17343609 ↗
• InjuryJul 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 215CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT NOTED A FOLD IN THE RIGHT BREAST IMPLANT. SUBSEQUENTLY, SHE EXPERIENCED RIGHT BREAST PAIN/DISCOMFORT, RIGHT BREAST BUMPS, BREAST LYMPHADENOPATHIES, BREAST IMPLANT ILLNESS, HOT FLASHES, HEADACHES, FATIGUE, INSOMNIA, AND IRRITABILITY. AFTERWARDS, SHE WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT ACCOMPANIED BY ABNORMAL BREAST LYMPH NODES USING MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING. ADDITIONALLY, SHE HAD A HEMANGIOPERICYTOMA THAT WAS SURGICALLY REMOVED AND RADIATED IN 2022. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08460 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 17343605 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 215CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15854925 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 215CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15854873 ↗
• InjuryApr 2, 2020Adverse 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 AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 215CC ON THE RIGHT SIDE AND WITH MENTOR MEMORYSHAPE BREAST IMPLANT 245CC ON THE LEFT SIDE AND SUFFERED FROM ¿ PAIN, FIRMNESS AND MULTIPLE SYMPTOMS ON THE RIGHT SIDE.¿ THE PATIENT EXPERIENCED SEROMA AND CAPSULAR CONTRACTURE BAKER GRADE II ON THE RIGHT SIDE CONFIRMED ON A MAMMOGRAM ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 9918384 ↗
• InjuryOct 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST SURGERY WITH 225CC MENTOR MEMORYSHAPE BREAST IMPLANT. NOW THIS PATIENT PRESENTED WITH RIGHT BREAST IMPLANT RUPTURE CONFIRMED BY ULTRASOUND. THE PATIENT COMPLAINED OF SHARP RIGHT BREAST PAIN IN THE UPPER RIGHT QUADRANT OF THE BREAST. UPON REPLACEMENT SURGERY ON (B)(6) 2019, THE RIGHT IMPLANT WAS FOUND TO BE INTACT. HOWEVER, TWO DISTINCT CREASES WERE FOUND. THE DEVICE WAS REPLACED WITH A 215CC MENTOR MEMORYSHAPE BREAST IMPLANT. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9207848 ↗