MAUDE Adverse Event Report: TRANSVAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Erosion (1750); Failure of Implant (1924); Pain (1994); Anxiety (2328); Depression (2361); Neuralgia (4413)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I was diagnosed with pudendal neuralgia approximately one year ago.It is so debilitating and i may have to go on disability.I cannot squat repeatedly or sit for too long without being in immense pain.The first time i felt the pain was from squatting at work and so everyone assumed it was a workers' compensation claim.My company spent tens of thousands of dollars on diagnosing me and treating me--though i am not healed.However, i did not learn until tonight until i read a journal that transvaginal mesh slings cause pudendal neuralgia, pain with intercourse, and pain with sitting.I learned about a year ago, that the mesh used was eroding in my vaginal and would eventually require surgery.I was not warned about the complications of vaginal mesh and neither the manufacturer of the mesh, nor my doctor bothered to contact me once it became known in the medical community for causing disabilities.It has cost my employer tens of thousands of dollars because my very first signs of pudendal neuralgia occurred while doing something at work, leading everybody, including me to think it was a work injury.Just last week, i took my first long drive in years only to learn that after months of physical therapy, the problem still exists because i could hardly stand the pain as i drove.It also now explains the pain i feel when i sit too long or whenever i squat.The mesh has eroded through my vaginal walls--so my partner feels it.Pieces have had to be surgically removed and i currently use estradiol to slow down the erosion.It caused a relationship to end, due to the pain it caused him, which devastated me and left me severely depressed.I was afraid to date for years as a result and so the quality of my life has been compromised.Finally, an old boyfriend came back into my life and i am terrified of sexual intimacy for fear of how this mesh may cause him pain and i'll be left again.The anxiety it has caused over the fear of losing him because of this and the severe fear of surgery making it worse has prevented me from taking the risk of another surgery.(i am currently 55.) furthermore, i only learned several months ago that this incompetent product--this transvaginal mesh, was eroding and protruding through the walls of my vagina.When the first piece of scratchy material was discovered and i went to the original gynecologist for it, my doctor never told me what had gone wrong.He charged me a fortune to have a tiny piece of the mesh removed by cutting it out because it was hurting my boyfriend during intercourse.He also said that i must have surgery to repair the rest and i needed to pay close to (b)(6) upfront, which i simply could not afford.And so, his silence and lack of explanation led me to believe that for many years, he had botched my surgery, when it was primarily this product that did so much damage.Please help me right a wrong.Thank you.I don't know if my new gynecologist can take a photo of it, but i can have her send you a report of her findings."unknown-call dr (b)(6)".Fda safety report id # (b)(4).

• Brand Name: TRANSVAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• MDR Report Key: 15455740
• MDR Text Key: 300246627
• Report Number: MW5112137
• Device Sequence Number: 1
• Product Code: OTN
• 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: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TOO TIRED TO LIST ALL NOW. PLEASE CONTACT ME.
• Patient Outcome(s): Disability; Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White