MENTOR MemoryShape Breast Implant 3541158Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00081317005445), received between Apr 12, 2019 and Aug 13, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 245cc MENTOR MemoryShape Breast Implant prosthesis. Post-operatively, the patient received Ultrasound and Magnetic Resonance Imaging for a left breast mass involving the left axilla. Imaging identified a ruptured left implant and a left axillary silicone granuloma. However, pre-operative diagnosis from a medical professional stated as bilateral rupture. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026. The left implant was confirmed ruptured and the right implant was observed without abnormalities. This report is for the right breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242926 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24521518 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD A BIOPSY OF THE LEFT BREAST DUE QUESTIONABLE FINDINGS ON MAMMOGRAM. FINDINGS WERE NEGATIVE, BUT IT WAS SUSPECTED THE INTERVENTION MAY HAVE DAMAGED THE IMPLANT. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT AND THE BEGINNINGS OF WATERFALL DEFORMITIES, BILATERALLY, DURING A PHYSICAL EXAM. MAGNETIC RESONANCE IMAGING CONFIRMED THE RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23374058 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23030724 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED BREAST WRINKLING ON AN UNSPECIFIED BREAST SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SINCE IT WAS NOT SPECIFIED WHICH BREAST HAD THE WRINKLING, BOTH THE LEFT AND RIGHT BREAST IMPLANT INFORMATION WILL BE PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN CLARIFYING INFORMATION IS MADE AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Paresthesia; Wrinkling

  MAUDE report 19515278 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED EXPERIENCING UNSPECIFIED HEALTH PROBLEMS, FEELING SICK, UNSPECIFIED LESION ON THE BRAIN, PROBLEMS WALKING, COGNITIVE PROBLEMS, POOR HEALTH, CAPSULAR CONTRACTURE, THREE TUMORS AROUND HER BREASTS, AND BREAST CANCER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS WERE NOT PERFORMED AS NO PATIENT CONTACT INFORMATION WAS PROVIDED. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-15195 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 18401948 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED EXPERIENCING UNSPECIFIED HEALTH PROBLEMS, FEELING SICK, UNSPECIFIED LESION ON THE BRAIN, PROBLEMS WALKING, COGNITIVE PROBLEMS, POOR HEALTH, CAPSULAR CONTRACTURE, THREE TUMORS AROUND HER BREASTS, AND BREAST CANCER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS WERE NOT PERFORMED AS NO PATIENT CONTACT INFORMATION WAS PROVIDED. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-15194 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 18401935 ↗
• InjuryDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14813 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 18348565 ↗
• InjuryDec 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 PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL RUPTURE OF HER PROSTHESES, WHICH WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14812 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 18348558 ↗
• InjuryOct 30, 2023Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. RUPTURE WAS CONFIRMED VIA MRI. ON (B)(6) 2203, MENTOR BECAME AWARE THAT PATIENT'S SURGERY IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18029948 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE BREAST IMPLANT BOTTOMING OUT, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, RUPTURE, AND FLATTENED IMPLANT ON THE LEFT SIDE POSTOPERATIVELY. DIAGNOSED AFTER PHYSICAL EXAM. IT WAS REPORTED THAT THE PATIENT SUFFERED CHEST INJURY ON THE RIGHT SIDE DURING RIDING HORSES. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH NON-MENTOR SIENTRA DEVICES ON AUGUST 1, 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17586393 ↗
• InjuryAug 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 245CC MENTOR MEMORY SHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE BREAST IMPLANT BOTTOMING OUT, CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, RUPTURE, AND FLATTENED IMPLANT ON THE LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. IT WAS REPORTED THAT THE PATIENT SUFFERED CHEST INJURY ON THE RIGHT SIDE DURING RIDING HORSES. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH NON-MENTOR SIENTRA DEVICES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17586388 ↗
• InjuryNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED LATE ONSET SEROMA AND RUPTURE POST PROCEDURE. PATIENT UNDERWENT A SURGICAL PROCEDURE TO DRAIN AND TEST SEROMA. TEST CAME BACK NEGATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 15731655 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS WITH THE GLOW STUDY UNDER (B)(4). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 245CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15179413 ↗
• InjuryNov 19, 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 UNSPECIFIED BREAST SURGERY WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III 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: Capsular Contracture

  MAUDE report 12844708 ↗
• InjuryNov 19, 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 UNSPECIFIED BREAST SURGERY WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III 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: Capsular Contracture

  MAUDE report 12844702 ↗
• InjuryMay 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. PATIENT REPORTED LOPSIDED BREASTS AND A NOTICEABLE SIZE DIFFERENCE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11758768 ↗
• InjuryMay 2, 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 HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. PATIENT REPORTED LOPSIDED BREASTS AND A NOTICEABLE SIZE DIFFERENCE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11758767 ↗
• InjuryApr 16, 2021Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 245CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED RUPTURE, DEVICE MIGRATION AND BREAST PAIN ON THE LEFT SIDE POSTOPERATIVELY. THE RUPTURE WAS CONFIRMED WITH AN ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 11682161 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 245CC AND EXPERIENCED MALIGNANT NEOPLASM ON THE LEFT SIDE POST-OPERATIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cancer

  MAUDE report 8895668 ↗
• InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 245CC AND EXPERIENCED LATE ONSET SEROMA ON THE LEFT SIDE POST-OPERATIONAL. AS A RESULT, THE PATIENT UNDERWENT SEROSANGUINEOUS FLUID ASPIRATION ON (B)(6)2019. THE ASPIRATED SEROMA TESTED NEGATIVE FOR MALIGNANCY. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 405CC ON (B)(6) 2019.

  Patient problems: No Code Available; Seroma

  MAUDE report 8776806 ↗
• InjuryJun 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 245CC MENTOR MEMORY SHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE AND ACCUMULATION OF PERI IMPLANT FLUID CREATING A SWOLLEN APPEARANCE. THESE FINDINGS WERE DISCOVERED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 245CC MENTOR MEMORY SHAPE IMPLANTS WAS PERFORMED. THE FLUID AROUND THE RIGHT BREAST WAS SENT FOR TESTING WITH RESULTS UNAVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available; Seroma

  MAUDE report 8664870 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH TWO 245CC MENTOR MEMORY SHAPE BREAST IMPLANTS IN (B)(6) 2003, DEVELOPED A BREAST CANCER RECURRENCE IN 2018 IN THEIR UNSPECIFIED BREAST. THE PATIENT HAS NOT UNDERGONE ANY RE-OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cancer

  MAUDE report 8656652 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 245CC BREAST IMPLANT AND EXPERIENCED FATIGUE, HEADACHES, AND PAIN ON THE LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8509347 ↗