MAUDE Adverse Event Report: ETHICON GYNECARE TVT SECUR; CYNECARE TVT SECUR

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934); Material Integrity Problem (2978)

Patient Problems Erosion (1750); Emotional Changes (1831); Neuropathy (1983); Pain (1994); Skin Inflammation (2443); Lethargy (2560); Foreign Body In Patient (2687)

Event Date 04/30/2014

Event Type  No Answer Provided  

Event Description

I was implanted with tvt secur in 2008, had exacerbation of asthma immediately, and developed symptoms of asia, by 2011.Developed excruciating pelvic and rectal pain suddenly, was diagnosed with pudendal neuropathy secondary to mesh complications.Developed severe depression, was suicidal when doctors were failing to diagnose internal mesh erosion, found blue fragments (hundreds of tiny fibers) coming out in my urine, felt like i had a bladder infection but tests indicated no infection, the fibers caused inflammation of skin around genitalia.Nine doctors later, eight months of pain that only oxycodone and morphine would touch, of laying still most days to reduce mechanical irritation of the mesh implant, and having all over pain, lethargy and being on suicide watch i had tvt secur mesh removed.However for months afterwards still had fibers in urine until they dwindled, and i stopped monitoring, now i am experiencing extreme depression and ptsd when realizing the fda is not going to include sui sling implants as class 3 devices, i am losing sleep worrying about the other women who may get implanted with this material that is not insert and falls apart inside our bodies and causes autoimmune issues when allowed to be a chronic problem.

• Brand Name: GYNECARE TVT SECUR
• Type of Device: CYNECARE TVT SECUR
• Manufacturer (Section D): ETHICON
• MDR Report Key: 3806934
• MDR Text Key: 18931307
• Report Number: MW5036039
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 79