• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD / DAVOL INC., SUB. C. R. BARD, INC. BARD SOFT MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD / DAVOL INC., SUB. C. R. BARD, INC. BARD SOFT MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number DOCTOR DID NOT GIVE ME THIS INFO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Fatigue (1849); Inflammation (1932); Pain (1994); Tachycardia (2095); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Palpitations (2467); Ambulation Difficulties (2544)
Event Date 04/04/2019
Event Type  Injury  
Event Description

Allergic mesh reaction destroying my qol. Two devices; coloplast altis urethra sling and bard soft mesh for sacrocolpopexy. Coloplast altis sling at one week post op initiated repeated uti, pain and gait disturbance, where none existed before. Removal of mesh required travel to another state at one month post op for surgery and stopped uti but some urine retention and discomfort remain. Still testing for damage and possible pudendal nerve entrapment. Successful removal of the anchors required travel for a second removal surgery at 13 months post op to a specialist in (b)(6) clinic in (b)(6) from another state. Although both anchors were found and removed, the anchors are not always found and few surgeons will attempt it. This surgery requires thigh dissection. By the way, my surgeon did not discuss the sling surgery with me. He knew i had no urinary incontinence. I did not know i was scheduled for urinary sling surgery. Previously he canceled my surgery because i had questions, so i couldn't ask about the surgery unless i took the risk of having it cancel again. The sacrocolpopexy mesh has created extremely disabling pain, disability and appears to have created new inflammation or increased inflammation body wide. The pain centers at the sacrum where the mesh is attached to a ligament to secure the vaginal vault from descending. The pain radiates along the pelvic bones and to the attached muscles. Everything inside and outside of my pelvis hurts including complications with my otherwise very healthy intestines. I was diagnosed with sibo recently. Walking is difficult. Fatigue, pain and recovery from activity has me sitting in a recliner on a heating massage pad 10-15 hours a day. I have my own tens unit to help with pain. I was very active before the mesh was installed in my pelvis. Mesh has increased inflammation throughout my body which is likely classified as autoimmune disease and different than simply local inflammation at the location of the mesh. I have a chronic blood cancer called polycythemia vera, a myeloproliferative neoplasm. It is characterized by some inflammation. The mesh has increased the symptoms beyond a manageable amount. Increased or different medications and even surgery are being considered to relieve symptoms. I am holding off significant changes until the mesh is hopefully removed. Other people have seen autoimmune type of mesh reactions stop if mesh is removed. I had minor svt but now with mesh i have often increased heart rate and pounding heart rate. I am short of breath. I am waiting to schedule an appointment to have the mesh removed by leading expert dr (b)(6) in (b)(6). Many women have repeated unsuccessful surgeries. It will mean another out of state travel, the fifth, and hotel stay for me and my husband during the risk of covid. I may never recover completely from these mesh complications and it is possible i could get worse. Mris, x-ray, us tests to look for pain causes found nothing. Now scheduled to look for inflammation markers for autoimmune. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD SOFT MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BARD / DAVOL INC., SUB. C. R. BARD, INC.
MDR Report Key10573679
MDR Text Key208370378
Report NumberMW5096812
Device Sequence Number1
Product Code FTL
Combination Product (Y/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 09/20/2020
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDOCTOR DID NOT GIVE ME THIS INFO
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/22/2020 Patient Sequence Number: 1
-
-