MAUDE Adverse Event Report: GYNECARE - ETHICON US LLC / ETHICON, INC. TVTOML MESH ABBREVO TVT 12CM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Catalog Number TVTOML

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682)

Patient Problems Fistula (1862); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Ambulation Difficulties (2544); Tissue Breakdown (2681); Fibrosis (3167); Neuralgia (4413); Kidney Infection (4502); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/07/2019

Event Type  Injury  

Event Description

Neuralgia, cprs, spastic msc; gynecare - ethicon us llc, product tvtoml mesh abbrevo tvt 12cm was implanted for sui on (b)(6) 2019, and i woke up from surgery in severe, debilitating pain.Required longer hospitalization than expected, multiple er visits, a revision surgery 4 1/2 weeks later, total removal by a specialist at 5 months post implant, and numerous and ongoing nerve blocks, ablations, and botox injections to help constant, debilitating pain.During second, total mesh removal surgery, remaining mesh arms were discovered eroding into left bladder wall and right adductor muscle.So far, at 2 1/2 years post implant, i've gone under anesthesia for mesh issues and pain management 18 times.Diagnosed with pudendal neuralgia and obturator neuralgia, spastic pelvic floor syndrome, and complex regional pain syndrome.Experienced multiple other side effects, including allodynia, chronic inflammation, foreign body giant cell reaction, fibrosis, gait in walking, and occasional need for extra support from a cane, walker, or wheelchair.Multiple specialists and pain management doctors have agreed with diagnosis of neuralgia, and believe that the path of mesh implant through the obturator muscle caused the muscles to continually spasm, compressing the pelvic nerves, causing the debilitating pain.I was told by the implanting obgyn surgeon and the first revision urologist surgeon that the mesh was implanted and positioned exactly as it was intended to be according to manufacturer ifu and formal training experience.Implant and multiple mesh removal surgeries also caused a urethrovaginal fistula and destroyed part of my urethra, causing multiple utis and a severe kidney infection, and requiring a full urethroplasty and fistula repair surgery, where my urologist had to cut out part of my vaginal tissue to create a new urethra and to patch the hole into my vagina, while the long recovery required a suprapubic catheter implant.My conditions caused by this mesh negatively affect my physical being, my mental health, my work life, my finances, my friendships, and my relationships.Sexual relations are only possible during short amounts of time when the surgeries are working well, and i require help with even basic things like grocery shopping, doing laundry, taking out the trash, and cooking meals in the time that my surgery is wearing off and i'm waiting for my next one.Ongoing surgeries every 3-4 months help manage the worst pain for a little bit, but after 2 1/2 years so far, there is little hope of full recovery.Fda safety report id# (b)(4).

• Brand Name: TVTOML MESH ABBREVO TVT 12CM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): GYNECARE - ETHICON US LLC / ETHICON, INC.
• MDR Report Key: 12475040
• MDR Text Key: 272482717
• Report Number: MW5103935
• 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
• Type of Report: Initial
• Report Date: 09/12/2022

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 Catalogue Number: TVTOML
• Device Lot Number: 3932651
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 57