MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Pain (1994); Prolapse (2475); Blood Loss (2597)

Event Date 08/13/2014

Event Type  Injury  

Event Description

I was diagnosed with central sensitivity syndrome, including fibromyalgia and chronic fatigue syndrome that i believe is directly related to the device.The device has penetrated the vaginal wall ad causes pain and bleeding.Vaginal prolapse is now at 50%.There is only one dr in (b)(6) qualified to remove the device in its entirety and he is located in (b)(6).I am currently trying to get an appt.Other (b)(6) drs are not comfortable removing the entire device, nor are they qualified.My health has been failing since the device was placed during a hysterectomy on (b)(6) 2007 at (b)(6) clinic).Fda safety report id# (b)(4).

• Brand Name: ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8541164
• MDR Text Key: 142944074
• Report Number: MW5086067
• Device Sequence Number: 1
• Product Code: FTL
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 77