MAUDE Adverse Event Report: ETHICON, INC. TVT TENSION FREE VAGINAL TAPE, BRAND TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number GYNECARE TVT-810041A

Device Problem Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Dysuria (2684); No Code Available (3191)

Event Date 06/16/2018

Event Type  Injury  

Event Description

I had tvt mesh sling surgery for stress incontinence on (b)(6) 2018.Returned to er on (b)(6) 2018 for bleeding, pain and difficulty with urinating.Sent home with catheter and had to straight cath for several weeks until it calmed down.Ever since i had difficulty urinating.I have difficulty with starting to urinate and when i do, it is just dribbles.I have had multiple visits to md office for uti.Urinary retention, pelvic pain, burning and pressure.The utis started in 2015 and i eventually was referred by my gyn to a uro/gyn surgeon in (b)(6) who did a revision removing some of the mesh.I was told all the mesh was removed.I never had any relief and eventually found another uro/gyn dr in (b)(6) who has given me multiple options.He told me that the previous dr only removed a portion of the mesh.I have lived since 2005 with this pain and the quality of life has been horrible.The tvt mesh has ruined my life.I was not explained the complications at that time and was told what a good product this was.If i had only known, i would never have put this disgusting device in my body.I am appalled it is still being used.It makes me want to cry.

• Brand Name: TVT TENSION FREE VAGINAL TAPE, BRAND TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 7978973
• MDR Text Key: 124360743
• Report Number: MW5080646
• Device Sequence Number: 1
• 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: 10/15/2018

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
• Device Operator: No Information
• Device Expiration Date: 04/30/2008
• Device Model Number: GYNECARE TVT-810041A
• Device Lot Number: 1089760
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 68