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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE GORE TEX; MESH
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W.L. GORE GORE TEX; MESH Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Abdominal Pain (1685); Failure of Implant (1924); Hernia (2240); Discomfort (2330); Discomfort (2330)
Event Date 07/25/2015
Event Type  Injury  
Event Description
First i was rushed to radiology with severe stomach pain.Then they did scan on my stomach, came back and told me i needed emergency surgery for a hernia so next morning they did my hernia surgery.The doctor used gore tex mesh, so after surgery i got even sicker.I got no better for 3 to 4 days, then they transferred me to another hospital, to fix the damage first doctor did to me.Another emergency surgery.So finally that surgery went well, then about two months later the gore tex mesh failed me.I had to have the gore tex picked out of my intestines piece by piece and the doctor's reason is he did my mesh with biological mesh, and i'm still under care.You all mean to tell me they think i'm letting get away with all this (profanity) they put me through.Three surgeries and gore tex is not being held accountable.I went through (profanity) and almost died two times, somebody's got to pay me for pain and suffering.I won't stop till this case has some kind of settlement.Yes they all owe me.
 
Event Description
Additional information received on 03/28/2018 on voluntary report mw5074647: first of all i reported to you all on more than one occasion.I have had mesh picked out of me.I almost died after first gore mesh surgery.Now i have biologic mesh.Went to my hernia doctor about a month ago and was told now another hernia appeared.But it is small right now and i may have to have a third surgery.But i blame you all for letting this poison get passed on to us.How could you all in jesus's name had let this happen to millions of people, why did you all do this to us.Millions are suffering because you all approved this mesh to be put in our body.Some people have caught gain green, some are in pain 24/7.And you all don't give a "profanity".It was not you so you can say forget us.That was so evil of you all to release deadly mesh.That's killing us slowly.How could you all let this ride, why aren't you standing up for millions of mesh victims.Really fda needs to be sued for letting this poison mesh get put in our body.You did it all for the money.Lord you all have really put us in our graves, how do you all sleep at night.Because i can't from mesh pain, constipation infection bowel obstructions.Stomach cramps and i am walking around with a big tidy on my stomach that sticks out like a sore thumb.Man fda you ruined my life by letting hernia mesh be put inside millions and you knew the side effects but us patients, we did not know.Many of you all need to put on (b)(6) news because you are killing lots of people for approving mesh.You all are responsible fully for approving this death wish mesh.I will never forgive fda for this.You all are the ones, fda because you all let this get approved and some suffering and some dying and others have died.Thanks fda for your approval of poison mesh.You all should feel horrible for approving this grave mesh.How do you all let this "profanity" get out of control like this.I'm going after you all because you all approved this.Mesh lawyers even being paid off by mesh factory not to take mesh clients, fda who are you protecting? is the product compounded: yes.
 
Event Description
Add'l info received on 02/23/2018, for report # mw5074647.My first hernia implant fail me; i already reported that one of you all; now i'm reporting the biologic mesh in me that may also be failing me.I went to dr last month, hernia dr had cat scan.He says another hernia coming through.Small right now, but "profanity" who "profanity" let these mfr put this poison in us that want hold.I'm so out done.Something better be done right away.If i may have to take a third surgery if it get any bigger, it bulging.Stick out like a big tidy or tumor in my stomach.Who let the mfr use this poison on people they all should pay because we are suffering.Put yourself in our shoes and the mfr paying.Lawyer off not to take hernia cases man, that's some terrible evil doing.I'm suffering put yourself in my shoes one day and see how you feel about you.You may have to have third hernia surgery.God help all who got this mesh in them because people are dying from this mess.Are you all the one who approved this mesh.Fda who are you all protecting.Whose side are you on.Your people are out here suffering from the medical devices, hernia mesh patches.They have destroyed lives.Do it matter the dr have put this "profanity" in us and the "profanity" keep failing us.Something got to be done or i'm going on the news in (b)(6).I'm going to tell all this to the world.My worry now is biologic mesh may be failing me.Seen dr in (b)(6) 2018, had cat scan and results shocking another hernia has appeared, scarry.Now what, so sad for me, first gore tech fail me, now my complaint is the biologic mesh.Biologic is used in me at this time but another hernia has appeared, don't know how long it will last.
 
Event Description
First i was rushed to radiology with severe stomach pain.Then they did scan on my stomach, came back and told me i needed emergency surgery for a hernia so next morning they did my hernia surgery.The doctor used gore tex mesh, so after surgery i got even sicker.I got no better for 3 to 4 days, then they transferred me to another hospital, to fix the damage first doctor did to me.Another emergency surgery.So finally that surgery went well, then about two months later the gore tex mesh failed me.I had to have the gore tex picked out of my intestines piece by piece and the doctor's reason is he did my mesh with biological mesh, and i'm still under care.You all mean to tell me they think i'm letting get away with all this (profanity) they put me through.Three surgeries and gore tex is not being held accountable.I went through (profanity) and almost died two times, somebody's got to pay me for pain and suffering.I won't stop till this case has some kind of settlement.Yes they all owe me.
 
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Brand Name
GORE TEX
Type of Device
MESH
Manufacturer (Section D)
W.L. GORE
MDR Report Key7202994
MDR Text Key97712869
Report NumberMW5074647
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age50 YR
Patient Weight77
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