MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTOML

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Ambulation Difficulties (2544); Foreign Body In Patient (2687); Fibrosis (3167); Neuralgia (4413); Unspecified Mental, Emotional or Behavioural Problem (4430); Renal Impairment (4499); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)

Event Date 07/31/2019

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2019 and the mesh was used.It was reported that the patient experienced neuralgia, cprs, and spastic msc.It was reported that the mesh was implanted for stress urinary incontinence and the patient woke up from surgery in severe, debilitation pain.It was reported that the patient required longer hospitalization than expected, multiple er visits, and a revision surgery four and a half weeks later, total removal by a specialist at five months post implant, and numerous and ongoing nerve blocks, ablations, and botox injections to help constant, debilitating pain.It was reported that during second, total mesh removal surgery, remaining mesh arms were discovered eroding into left bladder wall and right adductor muscle.It was reported that two and a half years post implant, the patient went under anesthesia for mesh issues and pain management 18 times.It was reported that the patient was diagnosed with pudendal neuralgia and obturator neuralgia, spastic pelvic floor syndrome, and complex regional pain syndrome.It was reported that the patient experienced multiple other side effects, including allodynia, chronic inflammation, foreign body giant cell reaction, fibrosis, gain 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.The patient 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.It was reported that the implant and multiple mesh removal surgeries also caused a urethrovaginal fistula and destroyed part of the urethra, causing multiple urinary tract infections, a severe kidney infection, and requiring a full urethroplasty and fistula repair surgery, where the urologist had to cut out part of the vaginal tissue to create a new urethra and to patch the hole into the vagina, while the long recovery required a suprapubic catheter implant.It was reported that the patient¿s conditions caused by this mesh negatively affected physical being, mental health, work life, finances, friendships, and relationships.It was reported that sexual relations are only possible during short amounts of time when the surgeries are working well, and the patient requires help with grocery shopping, doing laundry, taking out the trash and cooking meals.It was reported that the patient is waiting for the next surgery.It was reported that the patient has ongoing surgeries every three to four months help manage the worst pain for a little bit, but after two and a half years so far, there was little hope of full recovery.

Manufacturer Narrative

(b)(4).Maude report #: mw5103935.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12797219
• MDR Text Key: 284137848
• Report Number: 2210968-2021-11284
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

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: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3932651
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female