MAUDE Adverse Event Report: BARD AVAULTA MESH

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Inflammation (1932); Neuropathy (1983); Pain (1994); Tissue Damage (2104); Abnormal Vaginal Discharge (2123); Vaginal Mucosa Damage (2124); Weakness (2145); Cramp(s) (2193); Discomfort (2330); Depression (2361); Abdominal Cramps (2543); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 01/25/2015

Event Type  Injury  

Event Description

In 2007, my gyn referred me to dr (b)(6), for pop.She advised mesh implant.(b)(6) of 2007, she performed the procedure and released me instead of keeping me overnight because my son was with me and he was feeling sick.(b)(6) passed away 4 days later.He was my constant companion as he was ill since birth.I was thinking the recovery from surgery was complicated by the mourning of my son.I continued to bleed and experience cramping with extreme pain.I sought out dr (b)(6) again even though she had told me she was leaving her practice.She found the sources of my discomfort, an 'anchor' had worked its way out through the wall of my vagina.She then removed it and showed it to me.Then saying 'there is about 15 more in there and i would never want to have this mesh removed.' at that time, i wondered why she made that remark.She left the practice and as my problems increased, i had to seek out other doctors.The dangers of removal where then explained to me paralysing me with fear, leaving me with the feeling of doom.Pain with sitting, standing, concentrating, weakness, depression, and no hope for being able to do the things i used to, including sexual intimacy with my husband.My wearing pads is a daily thing as i have leakage vaginally and rectally.I use a cane most days just to get around the house.But most days, i am just homebound with nerve pain and inflammation.The pain in my pelvic area and abdomen moves constantly.I am now (b)(6) and feel overwhelmed that i have no more hope for a longer life.In the past 3 days, i've discovered w/ web sites for women and men who are victims of this bad, murderous mesh.Why isn't the government claiming down on this issue? dare i compare it to a holocaust, there will be no rescue for 60,000+ until it's too late.Two weeks ago, i saw a doctor who will only remove the body of the mesh, not the anchors or legs.He discovered that there are 3 meshes not just 1, meaning 3 major surgeries which recently have been described as too dangerous.That means finding a doctor to removal all the mesh at once, the mesh corrodes and moves into other organs.I'm feeling extreme rectal pain making me fear that it is just getting worse and worse.

• Brand Name: AVAULTA MESH
• Type of Device: AVAULTA MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 4466330
• MDR Text Key: 5321222
• Report Number: MW5040461
• Device Sequence Number: 3
• Product Code: OTP
• 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: 01/25/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 66