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U.S. Department of Health and Human Services


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Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Purulent Discharge (1812); Disability (2371); Pallor (2468); Foreign Body In Patient (2687); Test Result (2695); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Event Description
I had the gynecare prolift kit by j&j implanted (b)(6) 2007 by a team of doctors in (b)(6) to treat pop and rectocele and bladder lift.Was in so much pain for 4 months after the surgery that i knew something was not installed properly, all symptoms had returned only they were worse than before the surgery.All i could do was go to work, come straight home, got to bed, this was my life for 2 years.Dating from 2007 to 2009 was totally out of the question.I was in pain, my vagina and body stunk like melting plastic, i was dripping pus from my rectum, missed a day of work every week on average, lost medical insurance, went to numerous doctors searching for help but no doctor would say or suggest anything was wrong with the implants i had inside my body.My bowels could not move unless i put a gloved finger inside by butt and push up the loose flesh that fell down and closed by rectum off.I then started taking laxatives every day and night which kept me home, close to a bathroom.My poop smelled like a dead rat was inside my body.Had a mammogram, showed an abnormal mass on my left breast, it was not cancerous but how long before it comes back as cancer? seven years have passed since that dreadful gynecare prolift kit was installed.I got (b)(6) healthcare in (b)(6), had a colonoscopy, there.I see the perfect image of a white plastic looking object embedded inside my colon, went back to see my doctor and was expecting him to tell me that i needed to go have this device removed form my colon immediately but that did not happen, he told me it was a reflection from the light on the camera, i said "profanity" no it is the bladder sling or a part of the transvaginal mesh kit or rectocele device that was installed in 2007, this is why i am sick and in pain.The (b)(6) doctor looked like he saw a ghost, immediately said "oh my god, are you okay?" i expected him to say or ask me where i wanted to go to get this thing removed but that did not happen, he did send me for a ct scan but they said they were only told to do the "fly" lower abdominal and pelvic exam.Went back and forth asking for a report that would say the words transvaginal mesh or bladder sling but no one was talking, not a word.What in the "profanity" is going on here? why can't i get the help i need to get this "profanity" out of my body so maybe i can live to help take care of my son who is severely autistic.Is this asking too much? why is the fda sitting back and allowing more and more women to be implanted with this poisonous material? why are we not being contacted and told where we can go for help if we feel we have rejected these devices? is there anyone in the fda arena willing to call me or write me to tell me where i can go for help? i can file a lawsuit that will make the lawyers rich and give me very little money then i will still have to get this removed.(b)(6).
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key4253545
MDR Text Key5012187
Report NumberMW5039057
Device Sequence Number1
Product Code OTP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age47 YR
Patient Weight79