MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSVAGINAL TAPE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Patient Problems Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 03/01/2021

Event Type  Injury  

Event Description

I had a mesh tension free vaginal tape for sui (stress urinary incontinence) in 2016.In 2020 i had a hysterectomy and in 2021 the tvt (tension-free vaginal tape) mesh started to erode through my vaginal wall causing pain, abnormal discharge, lack of urinary control, and pain with intercourse affecting my quality of life.I am currently trying to find a surgeon to remove some or all of it as conservative tx (treatment) including vaginal estrogen suturing and abstinence has failed.

• Brand Name: TRANSVAGINAL TAPE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 18959939
• MDR Text Key: 338493181
• Report Number: MW5153045
• Device Sequence Number: 1
• Product Code: OTP
• 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: 03/19/2024

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White