MAUDE Adverse Event Report: MENTOR MENTOR BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Complaint, Ill-Defined (2331)

Event Date 01/10/2000

Event Type  Injury  

Event Description

I do not know the exact dates off hand.However i had in 2010 began to be diagnosed with many more autoimmune disorders.Rheumatoid arthritis sjogren's barrett's esophagus with hiatal hernia achalasia, hypertensive les graves disease, severe brain god, severe back pain and behind my left breast, and the worst one of all is this yuck that is trapped in my throat that many women from the breast implant illness site seem to have but mine is extreme i cough up lots of mucus and it's debilitating.I believe since i already had autoimmune disorders i should have never had silicone implants.I was diagnosed with ulcerative colitis back in 1986 since i've had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants.I believe as i stated before they have exacerbated my autoimmune challenges.Within the past 8 months i heard about breast implant illness, i do believe i suffer from it.The fatigue is devastating.I don't even know how to put it in words.I am hoping i will get better after explanting.I know many women do whether they have had autoimmune illness before or not! i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back.Important information: i have continued to get sicker and sicker and sicker without answers with this "yuck" that i'm dealing with.I am already disabled and with this in addition it's just too much i am devastated.This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat.Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and it's exhausting.I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i don't realize it was causing me to feel like i was choking even more.Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore.I have gone through all my savings trying to get better! i plan to find out what all i need to take to detox and try to get all this silicone out of my system! it looks like that's what i am coughing up sometimes like i said it's extremely sticky.

• Brand Name: MENTOR BREAST IMPLANTS
• Type of Device: MENTOR BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6604570
• MDR Text Key: 76534302
• Report Number: MW5070118
• Device Sequence Number: 1
• Product Code: FTR
• 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: 05/29/2017
• 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: No Information
• Device Expiration Date: 05/20/1999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 41 YR
• Patient Weight: 45