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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PELVIC MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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PELVIC MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Pain (1994); Injury (2348)
Event Date 09/18/2005
Event Type  Injury  
Event Description
Add'l surgeries; i was implanted with pelvic mesh for a cystocele and rectocele repair as well as a bladder sling.I've had multiple revision surgeries because of pain and other symptoms from mesh extrusion.I'm a masters educated nurse and have lost my job, my health, and my future.I am totally disabled and unable to work since 2011.I went from incredibly healthy to disabled within 6 years with my health rapidly decreasing from implant onwards.I am now facing a life-threatening and expensive surgery to attempt to remove all of the mesh.It has been an absolute nightmare.I'm only (b)(6) and i've lost the last 10-15 years of my life to this mesh.I have autoimmune diseases that i believe were brought on by the chronic inflammation and infection of my mesh.Fda safety report id# (b)(4).
 
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Brand Name
PELVIC MESH
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
MDR Report Key9786049
MDR Text Key182387157
Report NumberMW5093510
Device Sequence Number1
Product Code PAI
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
Report Date 02/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/03/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age50 YR
Patient Weight68
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