MENTOR MemoryGel Breast Implant 3543751Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00081317000891), received between Jan 7, 2019 and Mar 13, 2026 — classified as 88 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (44 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 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE UNKNOWN IN LEFT BREAST, BAKER GRADE II IN RIGHT BREAST). THERE WAS SOME MALPOSITION IN THE RIGHT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MOTIVA GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24591613 ↗
• InjuryMar 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE UNKNOWN IN LEFT BREAST, BAKER GRADE II IN RIGHT BREAST). THERE WAS SOME MALPOSITION IN THE RIGHT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MOTIVA GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24584149 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23762897 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) , 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23762886 ↗
• InjuryMay 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITHS 375CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE, RIGHT SIDED BREAST PAIN, AND RIGHT SIDED GRANULOMA POST PROCEDURE. THE RUPTURES WERE DIAGNOSED THROUGH MAMMOGRAPHY AND MAGNETIC RESONANCE IMAGIN. AS A RESULT, EXPLANT AND REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE RIGHT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2025-04439. ON (B)(6) 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22078597 ↗
• InjuryApr 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAMMOGRAPHY. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Granuloma

  MAUDE report 21914532 ↗
• InjuryMar 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND RIGHT-SIDE CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3503751BC; SERIAL NUMBER (B)(6), ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3503751BC; SERIAL NUMBER (B)(6), ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21608397 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, AND RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3503751BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3503751BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 21608396 ↗
• InjuryMar 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21602274 ↗
• InjuryJan 2, 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 SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING AN IN-PERSON VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024. SEVERAL 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: Capsular Contracture

  MAUDE report 21056148 ↗
• InjuryOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375 CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT EXPERIENCED FEELING SORENESS. 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 20524635 ↗
• InjuryOct 21, 2024Adverse 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 WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED ANISOMASTIA ON THE LEFT SIDE ALONG WITH MIGRATION AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20500252 ↗
• InjuryOct 8, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20398165 ↗
• InjuryOct 8, 2024Adverse 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 375CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20398008 ↗
• InjuryFeb 26, 2024Adverse 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 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WANTED HER TEXTURED BREAST IMPLANTS REMOVED AS SHE BELIEVES TEXTURED IMPLANTS ARE ASSOCIATED WITH LYMPHOMA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02352 FOR THE CONTRALATERAL EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18779667 ↗
• InjuryFeb 26, 2024Adverse 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 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WANTED HER TEXTURED BREAST IMPLANTS REMOVED AS SHE BELIEVES TEXTURED IMPLANTS ARE ASSOCIATED WITH LYMPHOMA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02353 FOR THE CONTRALATERAL EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18779663 ↗
• InjuryFeb 21, 2024Adverse 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 MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING MAGNETIC RESONANCE AND MAMMOGRAM IMAGING. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS ALSO NOTED TO HAVE BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. DURING THE SURGERY, THE REMOVED IMPLANTS WERE FOUND TO BE INTACT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02108 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18753012 ↗
• InjuryFeb 21, 2024Adverse 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 MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING MAGNETIC RESONANCE AND MAMMOGRAM IMAGING. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS ALSO NOTED TO HAVE BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS ON FEBRUARY 06, 2024. DURING THE SURGERY, THE REMOVED IMPLANTS WERE FOUND TO BE INTACT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-02109 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18752989 ↗
• InjuryFeb 14, 2024Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED PTOSIS AND ANIMATION DEFORMITY IN HER RIGHT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED IMPLANT DISPLACEMENT AND A RUPTURE OF HER RIGHT PROSTHESIS, WHICH WERE CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. THE DATE OF IMPLANTATION WAS PROVIDED AS AN ESTIMATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18706503 ↗
• InjuryFeb 6, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18652473 ↗
• InjuryFeb 6, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Rupture; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18652471 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 375CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18441316 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED LATE ONSET SEROMA IN THE RIGHT BREAST. SEROMA FLUID WAS COLLECTED AND SENT TO PATHOLOGY/CYTOLOGY FOR TESTING. THE FINAL CYTOLOGY REPORT IS NEGATIVE FOR MALIGNANT CELLS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 18154638 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED LATE ONSET SEROMA IN THE RIGHT BREAST. SEROMA FLUID WAS COLLECTED AND SENT TO PATHOLOGY/CYTOLOGY FOR TESTING. THE FINAL CYTOLOGY REPORT IS NEGATIVE FOR MALIGNANT CELLS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18154636 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT USING ULTRASOUND IMAGING AND BILATERAL BAKER GRADE II CAPSULAR CONTRACTURE OF THE BREASTS DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL. ADDITIONALLY, SILICONE HAS LEAKED INTO THE LEFT LYMPH NODES RESULTING IN GRANULOMA FORMATION. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT ON (B)(6), 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06961 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Post Operative Wound Infection

  MAUDE report 17634683 ↗