MAUDE Adverse Event Report: MENTOR IMPLANTS; BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Pain (1994); Thyroid Problems (2102); Tinnitus (2103)

Event Type  Injury  

Event Description

I had silicone breast implant and for years had every test there is to find out what was wrong with me.Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimoto's along with just guesses of what could be wrong.I explanted 3 weeks ago and all my pain is gone.I still have severe ringing in my ear that hasn't left.Something needs to happen you have dropped the ball on this.So many women are sick and get better after explant.Research needs to be done.

• Brand Name: IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6721511
• MDR Text Key: 80474109
• Report Number: MW5071059
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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: 07/16/2017
• 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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 81