MAUDE Adverse Event Report: JOHNSON & JOHNSON GYNECARE TVT ABBREVO; TRANSVAGINAL MESH SLING

Model Number TVTOML-GYNECARE ABBREVO

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Abrasion (1689); Erosion (1750); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Disability (2371)

Event Date 08/05/2015

Event Type  Injury  

Event Description

I had a bladder sling mesh placed on (b)(6) 2014 for urinary incontinence.I started having problems with the mesh.Saw my doctor on (b)(6) 2015.My mesh had eroded through my vaginal wall.I must seek medical attention out of state because no one in my area can remove or repair mesh.The doctor that placed the mesh can't remove or repair it.It has been less than a year since mesh was placed.I was not told about any side affects of the mesh.I was not given any information about the mesh before surgery.I was not aware that the mesh could cause erosion or any other problems.I am now one of many mesh victims that now have to live in pain.It has completely affected mine and my children's life on what we can and can't do until i see a specialist to have the mesh removed.I have constant pelvic pain in my pelvic area, legs and back.I have bleeding only after sex.My significant other of 3 years reports to me he can feel something sharp and scratchy feeling when we have intercourse that is scraping his penis.So, i haven't had an intimate relation with my significant other in months now.It has affected me emotionally.I cry everyday in pain and discomfort.I am a single mother of 2 children and can't do the things i need to do for them because i am in pain.My doctor confirmed on (b)(6) 2015 my mesh of 8 months old placed has eroded through my vaginal wall.I have dribbling urine again.I have a constant stabbing feeling in my vagina every time i sit down.I can't even walk without the mesh constantly rubbing every time i take a step.I worry every day and pray that the mesh doesn't damage any other internal organs.I will be off work 6-8 weeks after mesh removal surgery to recovery and will be out of work and that's praying surgery goes well and no other organs have to be repaired, which i won't know until i see a specialist.My records have been sent to a specialist.I am currently awaiting a phone call with appointment for mesh removal surgery.Please stop approving these companies to use and sell meshes! they are not helping.They are causing major problems for not only myself, but thousands of women across the us.I had a gynecare abbrevo tvt by johnson and johnson/ethicon.

• Brand Name: GYNECARE TVT ABBREVO
• Type of Device: TRANSVAGINAL MESH SLING
• Manufacturer (Section D): JOHNSON & JOHNSON
• MDR Report Key: 5053142
• MDR Text Key: 24924520
• Report Number: MW5055885
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/28/2015

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
• Device Expiration Date: 05/31/2015
• Device Model Number: TVTOML-GYNECARE ABBREVO
• Device Lot Number: 3783211
• Other Device ID Number: 052-LAB0013088
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CONCERTA
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 82