MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

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.

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6279000
• MDR Text Key: 65940896
• Report Number: MW5067460
• Device Sequence Number: 1
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALA; ALLERGY PILL; BUSPIRONE; CLA; DIGESTIVE ENZYMES; FLAX SEED OIL; LEXAPRO; MULTIVITAMIN ; PROPRANOLOL; SYNTHROID
• Patient Outcome(s): Disability
• Patient Age: 32 YR
• Patient Weight: 70