MAUDE Adverse Event Report: BARD DAVOL INC. BARD SOFT MESH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Itching Sensation (1943); Pain (1994); Burning Sensation (2146)

Event Date 05/07/2016

Event Type  Injury  

Event Description

I was implanted w/bard soft mesh, a 100 percent polypropylene hernia mesh repair.Within 2 days, pain was unbearable, despite 3-4 pain killers, incl.A pain-pump iv.The pain was slow to subside over weeks, started to feel better, then got worse again alongside tenderness of incision scar.Simultaneously, after healing began from the open surgery, i found i was becoming impotent.Extreme burning pain beginning with any kind of sexual or sensual stimulation and then feeling blocked or backed up and deep pain during ejaculation.Ins.Co.Refused to do anything, saying i must have reinjured myself, but upon reexamination by the surgeon, he found there was absolutely no new hernia.Ins.Co.Would not return my call after telling them this.Doctor didn't think it could be the mesh, but i told them the mfr.Of polypropylene said they stated the material is not for long term internal use.(at least one mesh maker knew this, even sending emails saying to not tell the mfr of polypropylene material what they are using it for.).It should have never been approved by fda.I am childless and informed polypropylene destroys the vas deferens.It seems to cause lots of problems.I wondered about my deep fatigue, the burning, itching scar area, etc before finding out.One man died, when his mesh, rejected by his body, came loose, wrapped around his colon and killed him.I've read of many other complications, so i take lots of supplements to offset the fatigue and other side affects temporarily, at my expense, while paid little, just so i don't die right away and can keep working.One surgeon advised that i need to take it out, but surgery to do so costs (b)(6).Lawyers might help if fda issues a recall on the mesh, bard soft mesh.Until then, i can't seem to find legal help.I don't want to die because of this mesh.The fda allowed mesh to be made of material the manufacturer plainly said should not be used for long term, internal repairs.So, the fda should issue an immediate recall.I cannot afford the surgery, and the mesh is still inside me.I'm told i need to have it removed as soon as possible.

• Brand Name: BARD SOFT MESH
• Type of Device: BARD SOFT MESH
• Manufacturer (Section D): BARD DAVOL INC.
• MDR Report Key: 6958145
• MDR Text Key: 89729838
• Report Number: MW5072816
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 72