MAUDE Adverse Event Report: JOHNSON AND JOHNSON / AMERICAN MEDICAL SYSTEMS, INC. MINI ARC ELEVATE WITH INTEPRO ETHICON; MESH SURGICAL FOR STRESS URINARY INCONTINENCE FEMALE

Catalog Number 720091-01

Device Problem Material Erosion (1214)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Erosion (1750); Burn(s) (1757); Emotional Changes (1831); Fatigue (1849); Hemorrhage/Bleeding (1888); Incontinence (1928); Swelling (2091); Urinary Retention (2119); Arthralgia (2355)

Event Type  Injury  

Event Description

I had mesh for bladder suspension.The first time i had put in 2006 was an ethicon device from johnson and johnson.I also hemorrhaged immediately following this surgery and had to be taken back to operating room.This surgery failed, as noted by doctor.Later that year i went to (b)(6), where i had a cadaver iv fascia lata sling put in.It was too tight and caused urinary retention and was taken down several months later.In (b)(6) of 2008, i had a mini arc mid ureteral sling and elevate mesh for enterocele and posterior repair.These were ams devices.I experienced erosion of mesh soon after this surgery.I experienced auto immune symptoms.Pain in joints, swelling of joints, pain and burning of skin, urge incontinence plus stress incontinence.Hashimotos, severe fatigue, rheumatoid arthritis and lyme disease.Eventually this mesh eroded through vaginal wall, causing pain and inability to have intercourse with my husband.In 2016, i had full removal at (b)(6) with dr (b)(6).He said i was one of his most complicated cases, with mesh erosions in multiple locations.It was a 4 hour removal, extremely complicated with much pain.It left me with severe incontinence, and an incisional hernia which allowed my bowels to lay on my bladder.Due to insurance restrictions i was unable to go back to (b)(6) for repair, and in (b)(6) 2017 i went to (b)(6) for repairs.These repairs were unsuccessful.I have not been able to successfully treat the incontinence and still suffer with severe incontinence as well as a myriad of auto immune issue.My insurance will not cooperate with a surgery at (b)(6) and there are no doctors in my network capable of doing a surgery.I struggle on a daily basis with my auto immune, fatigue, incontinence, emotional distress.

• Brand Name: MINI ARC ELEVATE WITH INTEPRO ETHICON
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE FEMALE
• Manufacturer (Section D): JOHNSON AND JOHNSON / AMERICAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 7850775
• MDR Text Key: 119646392
• Report Number: MW5079609
• Device Sequence Number: 2
• Product Code: PAH
• 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: 09/01/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 720091-01
• Device Lot Number: 570968002
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 61