MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ ETHICON, INC. TVTO 810081L MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Lot Number 3398117

Device Problem Output Problem (3005)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2010

Event Type  Injury  

Event Description

On (b)(6) 2010 i was implanted with tvto 810081l mesh from johnson and johnson.Upon awakening from surgery excruciating pain.Since that point i have had 17 surgical procedures/surgeries that includes five removals of mesh.I've had multiple infections.In 2014 i was diagnosed with complex regional pain syndrome and pudendal nerve damage.In 2015 i was diagnosed with obturator nerve damage because they actually had to cut the mesh off of my obturator foramen with a bone cutter.I've had major reconstructive surgery or infections gone home with catheters.My pain is every single day, it's an entity that lives inside my body even though they think they may have got all the mesh out.There are days where it feels like i'm sitting on broken glass, today's where it's filled with razors slicing through me.I can't forget the bugs with the razor sharp teeth that run up and down my legs and in the back of my butt.Days i feel like i want to cut off my feet because my crps flares.The worst pain of all is the pelvic pain, it's like there's someone cranking my pubic bone in an old rusty vice and it's just cutting me at the same time as crushing it.Are used to say that the mess was probably all gone.They can't say that anymore because they found a piece floating outside of my urethra that they had to remove.This has ruined my life but has destroyed my family.This started because my bladder was protruding out of my vagina, and i was told that placing a sling inside me would lift up my bladder and it would fix the problem.I also had light incontinence which now i wear depends and pads inside all throughout every single day while dealing with pain that is heartless to me it's host.I have been waiting for my day in court for very long time.If i had known back then everything that i have learned myself since then - product being made of poly propylene plastic the same plastic that makes lacrosse stick nets, that it degrades contracts i never would've made that decision to agree to this implant initially.The mesh actually twisted my colon.I actually believe it or not was lucky enough to have an mri done of my pudendal nerve where it was caught in the scan that there was proof of the pudendal nerve damage.I've was writing a journal for over 10 years.I have so many surgical pictures of the mess, i have x-rays photos of what my body look like after having to try to do yet another mass removal.I've kept it all hoping that someday it could be used to help all the other women out there.If someone really does want to talk to me, i would love to try to help.There are too many tests, surgeries, i have tried so many medication's and found to be allergic to so many.I've tried stimulator is implanted that failed because they caused more pain on top of that i was dealing with already.Surgical reports that are actually scary to read at least for me it was.Https://www.Nj.Com/healthfit/2017/04/massive_jj_pelvic_mesh_lawsuit_gets_autumn_court_d.Html.I have other number not sure if it's a model or serial number.Some have made a huge difference with swelling and infections.Fda safety report id # (b)(4).

• Brand Name: TVTO 810081L MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): JOHNSON AND JOHNSON/ ETHICON, INC.
• MDR Report Key: 12804268
• MDR Text Key: 280822422
• Report Number: MW5105281
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3398117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Patient Sequence Number: 1
• Treatment: BUFFERED FISH OIL ; CALCIUM ; CALL SPECTRUM MINERALS ; ELDERBERRY ; FOLATE ; MAGNESIUM ; MAGNESIUM ; MULTI VITAMINS ; PROBIOTICS; SO MANY VITAMIN D HIGH-DOSE 10,000 IU ; TURMERIC ; VITAMIN A ; VITAMIN C ; ZINC
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White