MAUDE Adverse Event Report: MENTOR MENTOR SILICONE BREAST IMPLANT SILICONE BREAST IMPLANTS

Event Date 12/10/2014

Event Type  Injury  

Event Description

I had mentor silicone implants in 2012. I was in a car accident in 2014. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. I had a 3-d mammogram and everything looked fine. I was convinced that the implants had ruptured even though it didn't show up. I had them taken out. Both of the implants had holes. I am convinced that all of my problems stemmed from the holes in them. I was fine for the first two years.

• Brand Name: MENTOR SILICONE BREAST IMPLANT
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6636341
• Report Number: MW5070359
• Device Sequence Number: 1
• Product Code: FTR
• Report Source: Voluntary
• Reporter Occupation: PATIENT
• Type of Report: Initial
• Report Date: 06/10/2017
• 2 DeviceS WERE Involved in the Event: 1 2

1 Patient Was Involved in the Event

• Date FDA Received: 06/10/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 06/10/2017 Patient Sequence Number: 1