MAUDE Adverse Event Report: C. R. BARD AVAULTA PLUS BIOSYNTHETIC SUPPORT; POLYPROPYLENE MESH

Device Problems Use of Device Problem (1670); Material Protrusion/Extrusion (2979)

Patient Problems Abrasion (1689); Cyst(s) (1800); Diarrhea (1811); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Myalgia (2238); Complaint, Ill-Defined (2331); Sweating (2444); Ambulation Difficulties (2544); Weight Changes (2607); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 04/06/2009

Event Type  Injury  

Event Description

I had a cr bard avaulta tvt sling placed in my bladder for prolapse.The dr perforated my bladder with one of the anchors.The sling was also placed so tight that my bladder was not able to work properly.I immediately became dependant on catheters.I had to have a revision to cut the sling.I had a partial removal done which did not help.I started to feel very sick within a few months and every part of my body started to hurt.I lost 40 lbs, my skin started to burn, my muscles started to throb and have horrible weakness, preventing me to be able to walk very far.My bones aches.My bladder spasms constantly.I was then diagnosed with interstitial cystitis in the bladder, had a cyst in the bladder, and fibromyalgia.Another 2 surgeries were done to attempt to remove the tvt sling.The anchors were not able to be removed and the mesh that was removed was covered with dark colored scar tissue.Nine years later, i still have pieces of the mesh being expelled through the vaginal wall.My urinalysis always shows blood in my urine, and shows i have infection.Sex became too painful for me.Mesh in the vaginal wall protruded and cut my ex husband's penis.That mesh was excised in the dr's office days later.My vaginal wall bleeds often.I have constant diarrhea and ibs symptoms.Constant headaches.Severe sweating in my hands and feet.Dark patches started showing up on my face.I have raynauds syndrome.Started dealing with restless legs syndrome.Potts disease showed up.Polyps showed up in my nose, and in the secondary colon.Now the bones in my spine are degenerating.I lost all of my teeth.I have pleurisy.I fight to keep my weight above 100 lbs.They placed an interstim in the bladder to help control pain.I was not "sick" before the tvt surgery, just had some vaginal pain after the birth of my second son in the year 2000, and was trying to address it.I can barely walk, can't work, and can't get help.You need to do something about polypropylene mesh, it is making us toxic, and killing us.Please do something.

• Brand Name: AVAULTA PLUS BIOSYNTHETIC SUPPORT
• Type of Device: POLYPROPYLENE MESH
• Manufacturer (Section D): C. R. BARD
• MDR Report Key: 7518380
• MDR Text Key: 108407984
• Report Number: MW5077262
• Device Sequence Number: 1
• Product Code: OTP
• 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: 05/13/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A DAILY MULTIVITAMIN ; CALCIUM; IBUPROFEN; MAGNESIUM; MEDTRONIC INTERSTIM FOR BLADDER; ZINC
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 31 YR
• Patient Weight: 46