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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS
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MENTOR SALINE BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Autoimmune Disorder (1732); Disability (2371); Fungal Infection (2419)
Event Date 03/13/2017
Event Type  Injury  
Event Description
About 23 years ago i was implanted with (b)(4) saline breast implants.I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years.I have seen many doctors with the conclusion being they don't know what is causing me to be ill.On (b)(6) i traveled out of state to have my implants removed by a surgeon highly qualified to do the proper en bloc/capsules removed procedure.I requested pathology be done.The report states candida albicans in both breasts between the implants and capsules.His concern is that this has traveled to my blood.He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor.This request has not been addressed as i am on medicaid.I am concerned i will not get the proper treatment to get well.Candida albicans are very antibiotic resistant and the proper diagnosis by cultures of the blood and antibiotic therapy has to be done the proper way.
 
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Brand Name
SALINE BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6471345
MDR Text Key72247458
Report NumberMW5068966
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/05/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: AMICA HOMEOPATHY. ; PRIOR TO SURGERY...CURRENTLY TAKING DIFLUCAN.; RX MEDS: I HAVE STOPPED ALL MEDICATIONS TWO WEEKS,
Patient Outcome(s) Life Threatening; Required Intervention; Disability;
Patient Age50 YR
Patient Weight54
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