MAUDE Adverse Event Report: BARD AVULTA PLUS POSTERIOR B; TRANSVAGINAL MESH

Catalog Number 486201

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Incontinence (1928); Neuropathy (1983); Pain (1994); Scarring (2061); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Date 10/18/2007

Event Type  Injury  

Event Description

Diagnosed with mgus in (b)(6) 2014 this is related to the immune system, a precancerous condition, started having tingling in both feet, the first symptom.Trans vaginal mesh made by bard was implanted in (b)(6) 2007 by dr (b)(6) at (b)(6) hospital (b)(6).My chief complaint was a cystocele which on examination also had a rectocele and because of the surgery a tot sling was implanted with a mesh kit for cystocele, rectocele.After surgery to correct stress urinary incontinence, incontinence was worse.Three years after the original surgery, i started noticing tingling in both feet which has become progressively worse and very painful, in which i am on high doses of gabapentin that does not take care of the pain.I am now seeing preop and had only thyroid problems.On (b)(6) 2014 i had 95% of the mesh implant removed by dr (b)(6) in (b)(6).He is one of the few that know how to remove the mesh and take the time.I lost a good bit of blood during the surgery and it is taking me a while to recover.As for the mgus i only hope that with the removal my immune system will stop attacking the nerves in my legs and feet and that the damage will be lessened.My husband and i have been unable to have sexual relations since being implanted with this mesh.On examination by dr (b)(6) it was found that my vagina was scarred down and shortened so it would have been impossible to have relation.Also he found on exam at the time of surgery that was a very complicated and very difficult surgery requiring extra time and effort.There was evident vaginal prolapse with a cystocele as well as a rectocele.This is why the mesh was implanted in the original surgery in (b)(6) 2007.There was severe urethral scarring from the mesh kit.Because of where the arms were implanted lateral to the anus, i had butt pain from the moment i woke up in the recovery room, which continues to this day.It was a very bad place to implant the mesh since that is where you sit!.

• Brand Name: AVULTA PLUS POSTERIOR B
• Type of Device: TRANSVAGINAL MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 3893770
• MDR Text Key: 19966601
• Report Number: MW5036778
• Device Sequence Number: 1
• 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: 06/18/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 06/18/2014
• Device Catalogue Number: 486201
• Device Lot Number: CVR10041
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 60 YR
• Patient Weight: 71