MAUDE Adverse Event Report: MENTOR MENTOR SILICONE BREAST IMPLANT

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 IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6636341
• MDR Text Key: 77545543
• Report Number: MW5070359
• Device Sequence Number: 2
• 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: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 82