MAUDE Adverse Event Report: ETHICON GYNECARE TVT; GYNECARE MESH

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Sepsis (2067); Tissue Damage (2104); Urinary Tract Infection (2120); Depression (2361); Foreign Body In Patient (2687)

Event Type  No Answer Provided  

Event Description

Ethicon gynecare prolift placement in (b)(6) 2006, failed to resolve problems with my prolapse.Gynecare tvt placement in (b)(6) 2007 also failed to resolve problems.More problems.Sexual pain, spasms and contractions, depression, loss of urine and bowels.2009 lost 12 inches of my colon.Sepsis throughout my body.Lost my job in 2012 due to many medical leaves which finally resulted in loss of (b)(6) protection for my employment at (b)(4).Years employed at this company.15 years.Removal of prolift and tvt attempt in 2010 by 2nd opinion doctor.Mesh embedded and only minimal of mesh removed.Physical therapy did not help with tightness and spasms.Appointment with a pelvic pain doctor next plan.Elavil and gabapentin helps with sleep and pain.Pudental nerve block failed to eliminate pain.Plan to attempt add'l physical therapy again.Approved for (b)(4) (b)(6) 2013.Received first (b)(4) payment in (b)(4) 2013.(b)(4) coordinator job with good health benefits and pay lost (b)(6) 2012 causing financial hardship.Drained my 401k.I am flat broke, sick and severely depressed.If i could go back in time and not have the prolift and tvt i would have a better life just dealing with the prolapse.Doctor who put in the slings said my life would change for the good.He was wrong and when i continued to advise him of my problems, he gave me the impression that i was a bother to him.I had chronic utis.With visual blood showings in my urine.Told him many times and he avoided me and pushed me on his physician assistant.I had chronic utis in the past.After prolift and tvt, my utis were very bad and i was placed on a maintenance dose of medications for my infections.I continue to have utis.

• Brand Name: GYNECARE TVT
• Type of Device: GYNECARE MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 3573256
• MDR Text Key: 4141838
• Report Number: MW5033822
• Device Sequence Number: 2
• Product Code: OTP
• 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: 01/08/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 49 YR
• Patient Weight: 91