MENTOR MemoryGel Breast Implant 3544800Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00081317001164), received between Jun 20, 2019 and Sep 10, 2026 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (18 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 41 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent Primary Breast Augmentation with an 800cc Siltex Mentor Gel Implant experienced bilateral capsular contracture post procedure. The patient underwent capsulotomy in 2019 and the device was reused. This is contraindicated. The patient then later was admitted to the emergency room when the device migrated. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report contains supplemental information for Mentor PSR reference number(b)(4).

  Patient problems: Capsular Contracture

  MAUDE report 50717494 ↗
• InjuryAug 26, 2026Use of Device Problem; Migration

  It was reported that a patient who underwent Primary Breast Augmentation with an 800cc Siltex Mentor Gel Implant experienced capsular contracture and device migration post procedure. The patient underwent capsulotomy in 2019 and the device was reused. This is contraindicated. The patient then later was admitted to the emergency room when the device migrated. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date. This report contains supplemental information for Mentor PSR reference number (b)(4).

  Patient problems: Capsular Contracture

  MAUDE report 50443013 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23659334 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23659328 ↗
• InjuryMay 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 800CC WAS DIAGNOSED WITH ¿SUSPECTED¿ RIGHT-SIDED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). PER THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED A ¿POSSIBLE BREAST INFECTION OR SEROMA OR BIA-ALCL¿ ON THE RIGHT BREAST. THE TREATMENT PLAN INVOLVED REMOVING THE BREAST IMPLANTS, LETTING THE POCKET HEAL FOR THREE MONTHS AND THEN RE-IMPLANTING AT A LATER TIME. IMAGING WAS PERFORMED, WHICH SHOWED FLUID AROUND THE RIGHT BREAST IMPLANT, BUT DUE TO THE AMOUNT OF FLUID AND SWELLING A RUPTURE CANNOT BE EXCLUDED. THE PATIENT MENTIONED THEY ¿WOKE UP IN THE MIDDLE OF THE NIGHT WITH PAIN, REDNESS, SWELLING AND FEVER¿. BREAST IMPLANT REMOVAL SURGERY WAS PERFORMED WHERE SAMPLES OF THE FLUID WERE COLLECTED AND SENT FOR FURTHER TESTING (RESULTS PENDING). SUMMARY OF THE INFORMATION PROVIDED IN THE OPERATIVE NOTE: BREAST IMPLANT REMOVAL SURGERY WAS PERFORMED ON 24-APR-2025. A TOTAL OF 300 CC OF STRAW-COLORED SEROMA FLUID WAS DRAINED FROM THE RIGHT PERIPROSTHETIC SPACE. THE RIGHT BREAST IMPLANT WAS RUPTURED, BUT THE LEFT IMPLANT WAS INTACT. BOTH WERE MENTOR 800 CC HIGH P

  Patient problems: Seroma

  MAUDE report 21986386 ↗
• MalfunctionApr 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 72-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2025. NO PRODUCT QUALITY ISSUES WERE REPORTED FOR THE RIGHT-SIDE DEVICE. ON (B)(6) 2025 , THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, IT CANNOT BE DETERMINED WHICH DEVICE IS THE SUSPECT MEDICAL DEVICE FOR THE REPORTED RUPTURE, SINCE THE TWO RECEIVED PRODUCTS HAVE THE SAME VOLUME ENGRAVED, BOTH DEVICES WERE FOUND DAMAGED PER ANALYSIS FINDINGS. HENCE, BOTH DEVICE RESULT ARE BEING SUBMITTED. HENCE, THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 21875770 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21874176 ↗
• InjuryMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21708297 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED DEVICE EXTRUSION POST PROCEDURE. THE DEVICE WAS WORKING ITS WAY THROUGH THE SKIN. THIS WAS DISCOVERED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pocket Erosion

  MAUDE report 21410834 ↗
• InjuryJul 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19661751 ↗
• InjuryJan 10, 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 REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6), 2023. DURING THE SURGERY, SEROUS FLUID WAS IDENTIFIED ON THE RIGHT BREAST AND THE LEFT BREAST IMPLANT WAS IDENTIFIED TO HAVE RUPTURED. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9938302 SN: (B)(6), AND (RIGHT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775 LOT: 9951806 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 18489635 ↗
• InjuryJan 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. DURING THE SURGERY, SEROUS FLUID WAS IDENTIFIED ON THE RIGHT BREAST AND THE LEFT BREAST IMPLANT WAS IDENTIFIED TO HAVE RUPTURED. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775, LOT: 9938302, SN: (B)(6) AND (RIGHT) 775CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SHPB775, LOT: 9951806, SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 18489633 ↗
• InjuryAug 29, 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 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED GEL BREAST PROSTHESIS ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Swollen Lymph Nodes/Glands

  MAUDE report 17647269 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 800CC AND EXPERIENCED BLISTER ON THE RIGHT SIDE POST-OPERATIVELY. PATIENT WAS SUNBATHING AND THE NEXT DAY HAD A BLISTER ON HER BREAST. THE AREA WAS COVERED BY 2 LAYERS OF CLOTHING. PATIENT HAD TO GO TO URGENT CARE TO HAVE THE BLISTER DRAINED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16920235 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-04768 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16802035 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-04769 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16802015 ↗
• InjuryApr 3, 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 A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2022-12153 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16668667 ↗
• InjuryOct 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 15591594 ↗
• InjurySep 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 15459069 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; RIGHT BAKER GRADE III, AND LEFT BAKER GRADE III/IV 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 15052426 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; RIGHT BAKER GRADE III, AND LEFT BAKER GRADE III/IV 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 15052422 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II-III IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14720704 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE II-III IN BOTH OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14720674 ↗
• InjuryOct 14, 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) YEAR-OLD MIXED-RACE (CAUCASIAN, AFRICAN AMERICAN, INDIAN, HISPANIC/LATINO) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY. THE SYMPTOMS ARE BREAST PAIN, MEMORY LOSS, HEADACHES, TISSUE TENDERNESS, SLEEP DISTURBANCE, BURNING SENSATION, MENTAL DISTRESS, INFLAMMATION, DIFFICULTY CONCENTRATING, NECROSIS AND INFECTION (TWICE), HYPOTHYROIDISM, SKIN RASH, LEFT IMPLANT IS VISIBLY MOVED AND WRINKLED ON SIDE, SCARRING, FATIGUE, HOT BY TOUCH, DISCOMFORT WEARING CLOTHES, AND SENSITIVE SKIN. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2014 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 12637328 ↗
• InjuryOct 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 MIXED-RACE (CAUCASIAN, AFRICAN AMERICAN, INDIAN, HISPANIC/LATINO) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY. THE SYMPTOMS ARE BREAST PAIN, MEMORY LOSS, HEADACHES, TISSUE TENDERNESS, SLEEP DISTURBANCE, BURNING SENSATION, MENTAL DISTRESS, INFLAMMATION, DIFFICULTY CONCENTRATING, NECROSIS AND INFECTION (TWICE), HYPOTHYROIDISM, SKIN RASH, LEFT IMPLANT IS VISIBLY MOVED AND WRINKLED ON SIDE, SCARRING, FATIGUE, HOT BY TOUCH, DISCOMFORT WEARING CLOTHES, AND SENSITIVE SKIN. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2014 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 12637327 ↗