MENTOR MemoryShape Breast Implant 3341255Recalls & reported problems
Mentor Texas L.P. · Medium Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 375cc |Textured|Contour|Silicone| · Class 3 · Implant
All models of MENTOR MemoryShape Breast Implant (65)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor MemoryShape silicone gel-filled breast implant is a textured implant used for breast augmentation. The 75 reports mostly describe the implant shell rupturing, fluid collecting around the implant, and the scar tissue tightening around it, along with pain and changes in breast shape; many patients underwent removal or replacement surgery. All 75 report injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00081317005339), received between Mar 19, 2019 and Oct 17, 2025 — classified as 75 injuries.
The most frequently reported specific device problem is “Material Rupture” (20 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem51
- Material Rupture20
- Migration5
- Appropriate Device Problem Term/Code Not Available4
- Migration or Expulsion of Device1
Patient problems
- Capsular Contracture22
- Deformity/ Disfigurement21
- Pain12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- No Code Available10
- Breast Discomfort/Pain6
- Seroma6
- Autoimmune Disorder4
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, MAMMOGRAM IMAGING RESULTS IDENTIFIED STABLE FIBROADENOMAS IN THE LEFT AND RIGHT BREAST. BOTH WERE BIOPSIED AND DETERMINED TO BE BENIGN. DURING A SUBSEQUENT ULTRASOUND, A RUPTURED RIGHT IMPLANT WAS IDENTIFIED IN ADDITION TO A STABLE LEFT BREAST OVAL NODULE DETERMINED TO BE BENIGN. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Breast Mass
MAUDE report 23329903 ↗InjuryOct 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, MAMMOGRAM IMAGING RESULTS IDENTIFIED STABLE FIBROADENOMAS IN THE LEFT AND RIGHT BREAST. BOTH WERE BIOPSIED AND DETERMINED TO BE BENIGN. DURING A SUBSEQUENT ULTRASOUND, A RUPTURED RIGHT IMPLANT WAS IDENTIFIED IN ADDITION TO A STABLE LEFT BREAST OVAL NODULE DETERMINED TO BE BENIGN. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Breast Mass
MAUDE report 23329899 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2015. ADVERSE EVENT # 2. LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6), DOI: (B)(6) 2015). DURING THE 10 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST RIPPLING (WRINKLING) REQUIRED BREAST IMPLANTS REMOVAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling
MAUDE report 22923955 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2015. ADVERSE EVENT # 1. (RIGHT SIDE/LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6) DOI: (B)(6) 2015). DURING THE 10 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST RIPPLING (WRINKLING) REQUIRED BREAST IMPLANTS REMOVAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling
MAUDE report 22923917 ↗InjuryAug 7, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED NECK PAIN AND BACK PAIN. THE PATIENT WAS ALSO DIAGNOSED, VIA IMAGING, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, THE PATIENT ALSO DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV), AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 22735222 ↗InjuryAug 7, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED NECK PAIN AND BACK PAIN. THE PATIENT WAS ALSO DIAGNOSED, VIA IMAGING, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, THE PATIENT ALSO DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV), AND BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 22735220 ↗InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED IMPLANT SITE FLUID COLLECTION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN ULTRASOUND AND MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22571679 ↗InjuryJul 16, 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 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH RIGHT BREAST IMPLANT RUPTURE. THE PATIENT ALSO DEVELOPED BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO NON-MENTOR IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22522903 ↗InjuryJun 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22204518 ↗InjuryFeb 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 375CC AND EXPERIENCED RUPTURE ON THE LEFT 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: Deformity/ Disfigurement
MAUDE report 21315894 ↗InjuryOct 23, 2024Adverse 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
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 20517663 ↗InjurySep 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20140989 ↗InjurySep 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20140988 ↗InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH MED WATCH-5155030, MW5155031, A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR MEMORYSHAPE 495CC, SILICONE PROSTHESIS EXPERIENCED UNEXPLAINED SYSTEMATIC SYMPTOMS POSTOPERATIVE, INCLUDING FATIGUE, HAIR LOSS, MUSCLE WEAKNESS, TINNITUS, BURNING SENSATION, DIZZINESS, ANXIETY, ARTHRALGIA], DEPRESSION, IRREGULAR PULSE, COGNITIVE CHANGES, WEIGHT CHANGES, WRINKLING, UNSPECIFIED RESPIRATORY PROBLEM, EYE / VISION PROBLEM, PREMATURE MENOPAUSE, BREAST DISCOMFORT/PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS ONE OF THE TWO REPORTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19841401 ↗InjuryApr 25, 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 WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 375CC GEL BREAST PROSTHESIS NOTICED THAT HER LEFT BREAST FELT SORE AND THAT IT WAS GETTING BIGGER WITH FLUID. THE PATIENT WENT TO SEE HER SURGEON AND 250 ML OF FLUID WAS DRAINED AND SENT FOR TESTING. AN HCP LATER DIAGNOSED POSSIBLE CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) FOR THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture; Fluid Discharge
MAUDE report 19185163 ↗InjuryMar 21, 2024Adverse 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 375CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED A SEROMA IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Capsular Contracture; Seroma
MAUDE report 18956393 ↗InjuryAug 9, 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
IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 17491656 ↗InjuryJul 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. 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: Deformity/ Disfigurement
MAUDE report 17269603 ↗InjuryJul 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. 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 DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 17269592 ↗InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PTOSIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06192 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 17004564 ↗InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH 375CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PTOSIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06193 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 17004563 ↗InjuryApr 20, 2023Adverse 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 SURGERY WITH A 420CC (RIGHT) AND A 375CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PAIN AND IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. THE PATIENT REPORTED THAT AN MRI AND MAMMOGRAM SHOWED FLUID AROUND THE IMPLANTS. 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 DEVICE.
Patient problems: Breast Discomfort/Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 16782100 ↗InjuryFeb 10, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 33-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED RIGHT SIDE INTRACAPSULAR RUPTURE POSTOPERATIVELY; DIAGNOSED VIA MRI. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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 16352835 ↗InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH ASYMMETRY OF THE RIGHT BREAST AND SHE WAS DISSATISFACTION WITH PROCEDURE OUTCOME. AS A RESULT, THE PATIENT UNDERWENT A UNDISCLOSED BILATERAL SURGICAL PROCEDURE TO CORRECT THE ISSUE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15628 FOR THE CONTRALATERAL EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 16070536 ↗InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH ASYMMETRY OF THE RIGHT BREAST AND SHE WAS DISSATISFACTION WITH PROCEDURE OUTCOME. AS A RESULT, THE PATIENT UNDERWENT A UNDISCLOSED BILATERAL SURGICAL PROCEDURE TO CORRECT THE ISSUE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15627 FOR THE CONTRALATERAL EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16070534 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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