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

Device Problem Hole In Material (1293)

Patient Problems Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Neck Pain (2433); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Weight Changes (2607); Foreign Body In Patient (2687); No Code Available (3191)

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
• MDR Text Key: 77545543
• Report Number: MW5070359
• Device Sequence Number: 1
• Product Code: FTR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

• 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