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MENTOR MemoryGel Breast Implant 3507640MCRecalls & reported problems

Mentor Texas L.P. · Smooth Round Moderate Classic Profile Gel-Filled Breast Implant, 640cc |Smooth|Round|Silicone| · Class 3 · Implant

All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Breast Implant (211)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Mentor MemoryGel silicone breast implant is used for breast augmentation and reconstruction. The 29 adverse event reports mostly describe the scar tissue around the implant tightening and contracting so the breast becomes hard, painful and misshapen, sometimes with the implant rupturing or shifting position, and several women needed surgery to remove or replace it. No deaths were reported; all 29 reports involved injuries. 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
28
Deaths reported
0
Injuries reported
28
Recalls naming it
0

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317004271), received between Nov 5, 2019 and Feb 17, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (11 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem19
  • Material Rupture11

Patient problems

  • Capsular Contracture14
  • Deformity/ Disfigurement5
  • No Code Available5
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Pain3
  • Post Operative Wound Infection3
  • Breast Discomfort/Pain2
  • Impaired Healing1

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 640CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED BOTH HER BREASTS LOOKED ABNORMAL WITH THE LEFT BREAST BEING FLAT, PAINFUL, AND HAVING KNOTS ALONG THE RIDGE. SHE NOTICED THE ISSUES AFTER LOSING A SIGNIFICANT AMOUNT OF WEIGHT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED, BUT NO DIAGNOSIS WAS PROVIDED. 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 24370541 ↗
  • InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 640CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED BOTH HER BREASTS LOOKED ABNORMAL WITH THE LEFT BREAST BEING FLAT, PAINFUL, AND HAVING KNOTS ALONG THE RIDGE. SHE NOTICED THE ISSUES AFTER LOSING A SIGNIFICANT AMOUNT OF WEIGHT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED, BUT NO DIAGNOSIS WAS PROVIDED. 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

    MAUDE report 24370539 ↗
  • InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR MEMORYGEL , 640CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

    Patient problems: Capsular Contracture

    MAUDE report 20668158 ↗
  • InjuryOct 9, 2024Material Rupture; Material Rupture

    IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MEMORYGEL, 640CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED BREAST PAIN, AND SYMPTOMATIC RUPTURE POSTOPERATIVE. TELEHEALTH + IN OFFICE VISIT DIAGNOSED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2024.

    Patient problems: Breast Discomfort/Pain

    MAUDE report 20409159 ↗
  • InjurySep 5, 2024Material Rupture; Material Rupture

    IT WAS REPORTED THAT A 38-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 640CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. CALCIFICATION WITHIN THE CAPSULE WAS NOTED. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 375CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3503751BC).

    Patient problems: Capsular Contracture

    MAUDE report 20148617 ↗
  • InjuryJun 4, 2024Material Rupture; Material Rupture

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 640CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED DURING EXPLANT. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 19464128 ↗
  • InjuryJun 4, 2024Material Rupture; Material Rupture

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 640CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED DURING EXPLANT. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 19464126 ↗
  • InjuryMay 20, 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 640CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKE GRADE III/IV 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: Capsular Contracture; Pocket Erosion; Post Operative Wound Infection

    MAUDE report 19353995 ↗
  • InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 640CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A WOUND INFECTION AND A SEROMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

    Patient problems: Post Operative Wound Infection; Seroma

    MAUDE report 19225938 ↗
  • InjuryMar 26, 2024Material Rupture; Material Rupture

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 640CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A SIZE EXCHANGE SURGERY TO IMPLANT 385CC (LEFT-SIDED) AND 340CC (RIGHT-SIDED) MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024. DURING THE SURGERY, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-03644 FOR THE CONTRALATERAL EVENT.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 18979067 ↗
  • InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 49-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BACK PAIN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

    Patient problems: Pain

    MAUDE report 17318350 ↗
  • InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 49-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BACK PAIN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

    Patient problems: Pain

    MAUDE report 17318348 ↗
  • InjuryApr 11, 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 AUGMENTATION WITH A 640CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A WOUND INFECTION 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: Post Operative Wound Infection

    MAUDE report 16717002 ↗
  • InjuryJan 23, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 640CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. CAT SCAN SHOWED INTRACAPSULAR RUPTURE AND CALCIFICATION AROUND THE LEFT DEVICE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2023.

    Patient problems: Capsular Contracture

    MAUDE report 16223876 ↗
  • InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENTS DEVICES WERE: (LEFT) 595CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG: 3507595MC, LOT: 9695737, SN: (B)(4) AND (RIGHT) 595CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG: 3507595MC, LOT: 7651931, SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Patient problems: Capsular Contracture

    MAUDE report 15802001 ↗
  • InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 59-YEAR OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENTS DEVICES WERE: (LEFT) 595CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507595MC LOT: 9695737 SN: (B)(4) AND (RIGHT) 595CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507595MC LOT: 7651931 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Patient problems: Capsular Contracture

    MAUDE report 15801955 ↗
  • InjuryMar 24, 2022Material Rupture; Material Rupture

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING IMPAIRED HEALING, ALLERGIES, ITCHY SKIN, FATIGUE, SCARRING, HAIR LOSS, DECREASED VISION, MEMORY LOSS, INFLAMMATION, AND WEIGHT GAIN POST-OPERATIVELY. IT WAS INDICATED THE PATIENT WOULD REQUIRE SURGICAL INTERVENTION TO CORRECT SCARRING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

    MAUDE report 13873671 ↗
  • InjuryMar 24, 2022Material Rupture; Material Rupture

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES AND SYMPTOMS INCLUDING IMPAIRED HEALING, ALLERGIES, ITCHY SKIN, FATIGUE, SCARRING, HAIR LOSS, DECREASED VISION, MEMORY LOSS, INFLAMMATION, AND WEIGHT GAIN POST-OPERATIVELY. IT WAS INDICATED THE PATIENT WOULD REQUIRE SURGICAL INTERVENTION TO CORRECT SCARRING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON FEBRUARY (B)(6) THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

    MAUDE report 13873499 ↗
  • InjurySep 28, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 595CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT AND BAKER GRADE IV ON THE RIGHT POST PROCEDURE. 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 12543642 ↗
  • InjuryAug 24, 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A UNSPECIFIED GEL MENTOR BREAST IMPLANT ON THE LEFT SIDE AND WITH MENTOR MEMORYGEL BREAST IMPLANT 640CC ON THE RIGHT SIDE AND SUFFERED FROM A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

    Patient problems: Capsular Contracture

    MAUDE report 12362270 ↗
  • InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL GRADE IV CAPSULAR CONTRACTURE AND RIGHT-SIDED LOCATION REACTION POSTOPERATIVELY. THE PATIENT HAD A FIVE-WEEKS POST-OP FOLLOW-UP ON 20-AUG-2020, AND THE PATIENT STATED SHE EXPERIENCED RIGHT-SIDED BREAST TENDERNESS AND SWOLLEN BREAST. AT ANOTHER POST-OP FOLLOW-UP ON 15-OCT-2020, THE DIAGNOSIS OF BILATERAL CAPSULAR CONTRACTURE WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #: 3507555MC) ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

    Patient problems: Capsular Contracture; Local Reaction

    MAUDE report 11174232 ↗
  • InjuryJan 14, 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 AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 640CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL GRADE IV CAPSULAR CONTRACTURE AND RIGHT-SIDED LOCATION REACTION POSTOPERATIVELY. THE PATIENT HAD A FIVE-WEEKS POST-OP FOLLOW-UP ON 20-AUG-2020, AND THE PATIENT STATED SHE EXPERIENCED RIGHT-SIDED BREAST TENDERNESS AND SWOLLEN BREAST. AT ANOTHER POST-OP FOLLOW-UP ON (B)(6) 2020, THE DIAGNOSIS OF BILATERAL CAPSULAR CONTRACTURE WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH 555CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #: 3507555MC) ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

    Patient problems: Capsular Contracture

    MAUDE report 11174226 ↗
  • InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 640CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS (BAKER GRADE IV IN RIGHT BREAST, BAKER GRADE UNKNOWN IN LEFT BREAST). BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 640CC GEL BREAST PROSTHESES ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

    Patient problems: Capsular Contracture; No Code Available

    MAUDE report 10418174 ↗
  • InjuryMay 13, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD NATIVE AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 640CC AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE AND BILATERAL RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; No Code Available

    MAUDE report 10051995 ↗
  • InjuryMay 13, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD NATIVE AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 640CC AND EXPERIENCED BREAST PAIN ON THE RIGHT SIDE AND BILATERAL RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

    MAUDE report 10051993 ↗

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