MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS MINI ARC R BLADDER SLING

Model Number 720191-01

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994); Urinary Tract Infection (2120); Urticaria (2278); Malaise (2359); Depression (2361); Fungal Infection (2419); Weight Changes (2607); Test Result (2695); No Code Available (3191)

Event Date 06/28/2011

Event Type  Injury  

Event Description

Mesh erosion from american medical system's device called miniarc precise sling.Four major surgeries for erosion, bleeding, uti, severe pain, hives, depression, it has ruined my life.

Event Description

On (b)(6) 2011 mini arc sling placed by dr (b)(6) for stress urinary incontinence.On (b)(6) 2012, started having uti's, yeast infections, stomach pain, low back pain, hip pain, groin pain, pain with intercourse, severe hives started.On (b)(6) 2012, ovaries and tubed removed - surgical menopause started.On (b)(6) 2013 severe low back pain, couldn't use the bathroom, ct scan ordered by dr (b)(6).Report said i had "kidney stones".Dr (b)(6) sent me to urologist dr (b)(6) - he does cystoscopy in (b)(6) offices and says that i have bladder stones, ulcer in bladder and mesh erosion.He did surgery that evening, he removed stones, cauterized "lesion" in bladder and "clipped" all the sling he saw.Go back for follow up, still in pain, but he blows me off and says i need to have a rheumatoid work up.Fast forward 9 months, still in pain, hives are terrible, weight loss, fatigue, just sick.I find dr (b)(6), urogynecologist, go for appt.He can "fix" me and get the sling out.On (b)(6) 2014, i go for surgery to have sling and anchors removed, well, that didn't happen.He was able to remove some of the sling and the right anchor.He said the "left side looked ok".Had to go back that same night and have emergency surgery because my bladder was "cut".So , here i am today, still in pain, still sick, still can't sit, still can't ride in a car without laying flat on my back.I am (b)(6).I was very active, a real go getter, that all changed when i had the mini arc sling placed 3 years ago.It has ruined my life, my husband's life and my 2 kids' lives.I was never told that fda issued a warning on this.Was the doctor supposed to let me know? was the hospital supposed to let me know? or the fda? i had no idea til about 2 weeks ago.Everyone has blown me off, and not believed me.It's sad, so very sad.I just wonder how they would feel if they had a piece of mesh growing out of their face.

• Brand Name: MINI ARC R BLADDER SLING
• Type of Device: MINI ARC R BLADDER SLING
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS
• MDR Report Key: 4136066
• MDR Text Key: 5394442
• Report Number: MW5038422
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720191-01
• Device Catalogue Number: 720191-01
• Device Lot Number: 739239036
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 61