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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Autoimmune Disorder (1732); Disability (2371); Fungal Infection (2419)
Date of Event 03/13/2017
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6471345
Report NumberMW5068966
Device Sequence Number1593968
Product Code FWM
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year1993
Device Explanted Year2017
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 04/05/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/05/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
OTC MEDS: AMICA HOMEOPATHY. ; PRIOR TO SURGERY...CURRENTLY TAKING DIFLUCAN.; RX MEDS: I HAVE STOPPED ALL MEDICATIONS TWO WEEKS,
Outcome Attributed to Adverse Event Life Threatening; Required Intervention; Disability;
Patient Age50 YR
Patient Weight54
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