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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

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MENTOR BREAST IMPLANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Thyroid Problems (2102); Anxiety (2328); Palpitations (2467)
Event Date 05/01/2015
Event Type  Injury  
Event Description
Approx 6 months after having breast implants, i was diagnosed with hashimoto's thyroid disease, which is auto-immune. I have experienced several problems with my thyroid, heart, severe headaches, etc. I was 100% healthy before the implants. I have no family history of auto-immune disease. I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. I believe this is all due to my saline mentor implants.
 
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Brand NameBREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6279000
MDR Text Key65940896
Report NumberMW5067460
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 01/22/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 01/22/2017 Patient Sequence Number: 1
Treatment
ALA; ALLERGY PILL; BUSPIRONE; CLA; DIGESTIVE ENZYMES; FLAX SEED OIL; LEXAPRO; MULTIVITAMIN ; PROPRANOLOL; SYNTHROID
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