MENTOR MemoryGel Breast Implant 3544475Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00081317003946), received between Aug 15, 2019 and Apr 9, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT AND WAS NOTED TO HAVE BILATERAL BREAST PTOSIS BY A MEDICAL PROFESSIONAL. SHE DESIRED REMOVAL OF HER IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2026. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24830965 ↗
• InjuryApr 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT AND WAS NOTED TO HAVE BILATERAL BREAST PTOSIS BY A MEDICAL PROFESSIONAL. SHE DESIRED REMOVAL OF HER IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2026. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24830964 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24521207 ↗
• InjuryNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESIS THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE ULTRASOUND RESULTS SHOWED A BENIGN CYST IN THE LEFT BREAST AND BILATERAL AXILLARY LYMPHADENOPATHY DUE TO SILICONE-LADE LYMPH NODES. LASTLY, THE PATIENT DEVELOPED BILATERAL DOUBLE BUBBLE DEFORMITY AND BILATERAL BREAST ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-10673 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s); Deformity/ Disfigurement; Granuloma; Wrinkling

  MAUDE report 23612864 ↗
• InjurySep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE AND CAPSULAR CONTRACTURE (BAKER GRADE 4) 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: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099258 ↗
• InjuryMay 21, 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 PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 475CC AND EXPERIENCED IMPLANT SITE FLUID COLLECTION ON THE LEFT SIDE AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060016 ↗
• InjuryApr 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 BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, MRI RESULTS INDICATED MINIMAL FLUID IN RIGHT BREAST AND SMALL TO MODERATE FLUID IN THE LEFT BREAST. RESULTS ALSO INDICATED MILD LEFT AXILLARY LYMPHADENOPATHY WITH NUMEROUS BORDERLINE ENLARGED LYMPH NODES. ON (B)(6) 2025, PATIENT UNDERWENT A ULTRASOUND-GUIDED LEFT BREAST FLUID COLLECTION ASPIRATION PROCEDURE. APPROXIMATELY 40CC OF SEROUS FLUID WAS DRAINED FROM THE SPACE AROUND THE LEFT BREAST IMPLANT. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 21895226 ↗
• InjuryApr 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 BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 475CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, MRI RESULTS INDICATED MINIMAL FLUID IN RIGHT BREAST AND SMALL TO MODERATE FLUID IN THE LEFT BREAST. RESULTS ALSO INDICATED MILD LEFT AXILLARY LYMPHADENOPATHY WITH NUMEROUS BORDERLINE ENLARGED LYMPH NODES. ON (B)(6) 2025, PATIENT UNDERWENT A ULTRASOUND-GUIDED LEFT BREAST FLUID COLLECTION ASPIRATION PROCEDURE. APPROXIMATELY 40CC OF SEROUS FLUID WAS DRAINED FROM THE SPACE AROUND THE LEFT BREAST IMPLANT. 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 BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 21895214 ↗
• InjuryApr 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 475CC AND EXPERIENCED 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21742272 ↗
• InjuryMay 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE TWO 470CC MENTOR IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19385801 ↗
• InjuryMay 21, 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 UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON MAY 7, 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB585 LOT: 9987091 SN: (B)(6) AND (RIGHT) 585CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB585 LOT: 9987091 SN:(B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19361587 ↗
• InjuryApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING MAGNETIC RESONANCE IMAGING. SUBSEQUENTLY, A LYMPH NODE BIOPSY WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH GRANULOMAS OF THE BREASTS. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-04266 FOR THE CONTRALATERAL EVENT.

  Patient problems: Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074526 ↗
• InjuryApr 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING MAGNETIC RESONANCE IMAGING. SUBSEQUENTLY, A LYMPH NODE BIOPSY WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH GRANULOMAS OF THE BREASTS. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 645337-2024-04265 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Mass; Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074521 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3), AND A GRANULOMA AND A RUPTURE AND ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT IMPLANT SITE FLUID COLLECTION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17818679 ↗
• InjurySep 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3), AND A GRANULOMA AND A RUPTURE AND ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT IMPLANT SITE FLUID COLLECTION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818591 ↗
• InjuryMar 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED LEFT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. THE PATIENT HAD AN MRI, AND IT ALSO FOUND THAT THE RIGHT BREAST IMPLANT WAS EMPTY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6)2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16542135 ↗
• InjuryMar 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 475CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED LEFT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. THE PATIENT HAD AN MRI, AND IT ALSO FOUND THAT THE RIGHT BREAST IMPLANT WAS EMPTY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16542133 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THAT A 52-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT AND A 475CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED AN ANAPLASTIC LARGE CELL LYMPHOMA DIAGNOSIS POST PROCEDURE. THE PATIENT PRESENTED WITH A LEFT GROIN MASS. A BIOPSY WAS PERFORMED ON (B)(6) 2022 AND THE FINAL DIAGNOSIS WAS ANAPLASTIC LARGE CELL LYMPHOMA. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2023-00337 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Capsular Contracture

  MAUDE report 16134880 ↗
• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A RIGHT-SIDED 450CC MENTOR MEMORYGEL BREAST IMPLANT AND A LEFT-SIDED 475CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF THE RIGHT BREAST PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASOUND. THE PATIENT REPORTED EXPERIENCING PAIN, SWELLING, AND A CHANGE IN THE SHAPE OF HER RIGHT BREAST. THE PATIENT WAS ALSO DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15723 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16077894 ↗
• InjurySep 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 28-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC (LEFT), 475CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15339311 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH TWO 475CC MENTOR MEMORYGEL , SILICONE BREAST IMPLANT, HAS EXPERIENCED UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING UNEXPLAINED BODY ACHE, FEVERS ONCE EVERY MONTH UP TO THREE WEEKS, AND LAST NO MORE THAN 24 HOURS. NO RESPONSE RECEIVED AFTER MULTIPLE ATTEMPTS TO GET ADDITIONAL INFORMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

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

  MAUDE report 15294468 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH TWO 475CC MENTOR MEMORYGEL , SILICONE BREAST IMPLANT, HAS EXPERIENCED UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING UNEXPLAINED BODY ACHE, FEVERS ONCE EVERY MONTH UP TO THREE WEEKS, AND LAST NO MORE THAN 24 HOURS. NO RESPONSE RECEIVED AFTER MULTIPLE ATTEMPTS TO GET ADDITIONAL INFORMATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

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

  MAUDE report 15294438 ↗
• InjuryDec 22, 2021Material 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 (B)(6) HISPANIC/LATINO FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT-SIDED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 13063536 ↗
• InjuryMar 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 HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 475CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL LOCAL REACTION OF THE BREASTS POSTOPERATIVELY. THE PATIENT REPORTED COMPLICATIONS OF BILATERAL FLUID BUILD UP AND PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Local Reaction; Seroma; Skin Inflammation/ Irritation

  MAUDE report 11532778 ↗
• InjuryMar 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 HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 475CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL LOCAL REACTION OF THE BREASTS POSTOPERATIVELY. THE PATIENT REPORTED COMPLICATIONS OF BILATERAL FLUID BUILD UP AND PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Local Reaction; Seroma; Skin Inflammation/ Irritation

  MAUDE report 11532777 ↗