MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Thyroid Problems (2102); Anxiety (2328); Palpitations (2467)
Date of Event	05/01/2015
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6279000
• Report Number: MW5067460
• Device Sequence Number: 16779551
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/22/2017
• 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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALA; ALLERGY PILL; BUSPIRONE; CLA; DIGESTIVE ENZYMES; FLAX SEED OIL; LEXAPRO; MULTIVITAMIN ; PROPRANOLOL; SYNTHROID
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 32 YR
• Patient Weight: 70