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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON GYNECARE PELVIC MESH PROLIFT SYSTEM MESH IMPLANT

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JOHNSON & JOHNSON GYNECARE PELVIC MESH PROLIFT SYSTEM MESH IMPLANT Back to Search Results
Event Date 10/19/2007
Event Type  Injury  
Event Description

A doctor used a pelvic prolene gynecare mesh system inside my body without my permission, and i had no knowledge of the product being placed inside me until it was there and i could feel it eroding out. This device is so wrong. And horrible. It has literally ruined my life. My babies, i can't even lift them or grab them by their arms and swing them around in circles due to the pelvic pain inside my body. Since i am your guinea pig, your "clinical trial", here's what i have to say about your product. It is eroding out of wherever it is supposed to be, and is stuck inside my vagina. I can feel it with my finger, and my husband can feel it with his penis. It hurts him and it hurts me. It makes the inside of my vagina stink, no matter what i do, douche, soap, water, baths, swimming pools with chlorine, antibiotics, nothing helps! the smell is there and disgusts me everytime i attempt to have sex with my husband. The insides of my legs - crevices - my groin hurts all day long 24/7 and has for 2 years. I can't even wear panties, or blue jeans because it causes too much pain. My hips hurt as well, excruciating pain that extends into my thighs and back of legs. I feel poke, poke, poke, poke, no matter what i am doing. Sitting here typing this, i feel poke!!! it's sharp and hurts. It feels like a porcupine! i can hardly pee when i have to, and then sometimes i pee way too much. I can't hold my pee and have peed on myself in public on many occasions. Why did this product have to ruin my life so early on? if i can have sex, it is interrupted so many times by trips to the toilet, to of course, pee. Or push so hard to try and pee, and nothing happens, but yet you feel as if your bladder is going to burst. I have been held back from my babies, i can no longer have them now, and the one i do have, i have had to not hold this way, or can't rock him this way because his feet or knees or elbows touching my pelvic cause a horrid pain. My oldest constantly says "momma's bladder is hurting her, little brother, let her sit by herself. " what child should have to say that? or be worried with their mommy. I had my children young, and we had our whole lives to live, happy! instead, they have suffered from my depression, anxiety, and mental state due to this mesh inside my vagina. It's not fair. You people need to get this creation off the market. Stop destroying women and their lives! this is pitiful, pathetic. Destroying peoples' lives one piece of mesh implant at a time! that's just great! dates of use: 2007 - 2009. Diagnosis or reason for use: i don't know.

 
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Brand NameGYNECARE PELVIC MESH PROLIFT SYSTEM
Type of DeviceMESH IMPLANT
Manufacturer (Section F)
JOHNSON & JOHNSON
Manufacturer (Section D)
JOHNSON & JOHNSON
Device Event Key1533562
MDR Report Key1471196
Event Key1399701
Report NumberMW5012690
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/10/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 09/10/2009 Patient Sequence Number: 1
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