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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
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MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Headache (1880); Memory Loss/Impairment (1958); Miscarriage (1962); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Palpitations (2467)
Event Date 07/01/2007
Event Type  Injury  
Event Description
(b)(4). Approx. 5 years after receiving mentor saline siltex textured implants in (b)(6) of 1999, i started to display many symptoms of autoimmune disorders among other strange symptoms. Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimoto's, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others). I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. I ultimately explanted in (b)(6) of 2016.
 
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Brand NameMENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6890804
MDR Text Key87230992
Report NumberMW5072411
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
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