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
• 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

• Date FDA Received: 01/22/2017
• 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 Age: 32 YR
• Patient Weight: 70
• Patient Treatment(s): ALA; ALLERGY PILL; BUSPIRONE; CLA; DIGESTIVE ENZYMES; FLAX SEED OIL; LEXAPRO; MULTIVITAMIN ; PROPRANOLOL; SYNTHROID
• Patient Outcome(s): Disability