MAUDE Adverse Event Report: MESH IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Pain (1994); Disability (2371)

Event Date 06/01/1993

Event Type  Injury  

Event Description

I am one of the consumers that had the mesh bladder sling implanted in early 1994.This procedure caused me a lot of pain and completely ended my life as a wife.This is the most painful thing that i have ever had.My sex life as a wife ended at (b)(6) and my husband wondered what was wrong.Well sex was so painful and the next day you would be hurting almost to the point of thinking that something is wrong in your mind.The doctor thinks you are just over acting and there is something wrong in your marriage.Now the time has lapsed and no help for the ones that suffered the most and are still suffering.My mind is completely blown away.How can you put a price on the pain this company caused.I want to have it removed, but i am afraid to.Reason for use: bladder leaking.

• Brand Name: MESH IMPLANT
• Type of Device: MESH IMPLANT
• MDR Report Key: 4883010
• MDR Text Key: 5865736
• Report Number: MW5043355
• Device Sequence Number: 1
• Product Code: OTM
• 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: 06/25/2015

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2015
• Patient Sequence Number: 1
• Treatment: RX MEDS: BLADDER SLING
• Patient Outcome(s): Other; Disability
• Patient Age: 41 YR
• Patient Weight: 70