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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON / JOHNSON & JOHNSON GYNECARE JOHNSON & JOHNSON TVT MESH IMPLANT

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ETHICON / JOHNSON & JOHNSON GYNECARE JOHNSON & JOHNSON TVT MESH IMPLANT Back to Search Results
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Reset Problem (3019)
Patient Problems Emotional Changes (1831); Incontinence (1928); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Burning Sensation (2146); Cramp(s) (2193); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Sleep Dysfunction (2517); No Code Available (3191)
Event Date 02/09/2015
Event Type  Injury  
Event Description
Since gynecare bladder implant mesh of (b)(6) 2015 i went through 4 surgeries - 5 included with gynecare of 2015.One surgery in 2016 the other so far just recent of 2017 to try and correct and fix the mix incontinence included with chronic pressure discomfort pain along with uti besides 7 follow treatment care to help controlled uti pelvic bladder discomfort with mix incontinence which i'm still and will continue to be on daily antibiotic for life, been on daily antibiotic since 20156 to this present after gynecare mesh this surgeon kept me on gynecare bladder mesh implant - manufacture is to blame for my injuries of (b)(6) 2015 - since then, i have been experiencing multiple complications, manufacture failed to warn about the health risk - failed to warn about any side effects-no pamphlet or brochure was given to learn about mesh implant.Since 2015 after mesh implant about 2 to 3 months later i experienced complication after complication and made my health worse, if this urologist would have known about any of these serious risks would not have implanted this gynecare mesh.This gynecare i experienced chronic severe cramping discomfort bladder - pelvic pressure pain like labor shooting pain that keeps me awake at night, have been on uti antibiotic daily since 2015.This urologist kept me on, been on ibuprofen and tylenol after 2015 for discomfort pelvic and bladder pain, have been going through multiple surgery since 2015 and follow up appointment and ongoing surgery for stress mix incontinence, been put on dementia meds to help with memory loss, dr believes it does have to do with different meds i was put on for pain - anxiety - and sleep insomnia from lack of sleep, as well as ongoing follow surgery and ongoing dr visit with a further distance appointment that was triggering my memory due to ongoing bladder implants.As i was getting more depressed - and with more anxiety it was interfering with my family life style since this mesh gynecare implant when i started to experience complication more complication dr had told me i would need an artificial splinter as it would take me much further distance to try and fix or correct.It would take several surgeries and then again he says no promise of a fix and it would be too risky, as i just found this out as well only after surgery when complication occurred as these scars cause me sharp pain life time no fix, life time ongoing surgery and follow up with interstim implant to help my leakage mix incontinence.As im stuck with this gynecare mesh inside of me that's interfering with my pelvic - bladder - now my bowel using undergarment daily - pads, out of my own pocket expenses whenever a bladder leakage happens.Traveling, gas expenses, motel stay, ongoing surgeries.Follow up appointments, 3 to 4 times a year out of town at a further distance, loss family fun time once i use to enjoy, loss sexual involvement with spouse, as it put pressure on my husband into our marriage, and our family life style, this gynecare implant mesh causes more harm than good, causes bleeding - over flow incontinence - life time sharp chronic pelvic - bladder discomfort, cramping labor pain - life time ongoing follow up appointments.Implant surgeries - life time scarring inside and out.Life time undergarment - pads - life time stress - loss track of interest in family time and - loss sexual involvement with spouse.That put pressure in our marriage, that cause some memory impairment of what i went and still going through to get proper care i need.Life time daily antibiotic for uti since 2015 since after mesh implant.On ibuprofen and tylenol put together for discomfort pain since 2016 to present.Prescription meds.Was put on donepezil tab 5 mg for memory loss of 2017, and now dr increase donepezil at 10 mg daily to dissolve for memory.Ps tell the manufacture company to take these implants off the market, it does more harm than good.
 
Event Description
Add'l info received from reporter on 08/21/2017 for report # mw5070041: amitriptyline - notice memory impairment.Dr had to wean me of 2017 affecting memory.Cymbalta - memory zap - dizzy spells more depression been on this for years.Hydrocodone - shortness of breath, chest pain, anxiety was given in 1-day surgery after or implanted tvt mesh on (b)(6)2015 later chronic about one and a half to 3 months later, i started feeling sharp pain, discomfort, labor pelvic, labor daily, burning pain.Did tell the doctor had ongoing uti infection that now i take antibiotics daily since 2015.He put me on along with vaginal cream with daily ibuprofen with tylenol that is prescribed by my doctor.Ovestrion; "why do you want to know my condition when none of these help my condition that has to do with the mesh." since 2015, i have been going to doctors at a further distance, for discomfort bladder and pelvic pain, and ongoing surgeries with f/u appts with daily antibiotic for uti, with daily pain meds since 2015 due to mesh.Device implants that caused me out of pocket, expensive, motel stay, gas expenses, copays, wear and tear from seeing a doctor at a further distance that also put my marriage on the line, loss friendship companion.Loss once i use to enjoy, loss sexual involvement with spouse, it put stress in our marriage, loss family life enjoyment, put more stress depression in our marriage.I depend on spouse to take me to my appointments, to do errands, to cook, to help around the house when i don't feel well, due to discomfort-chronic severe pelvic pain.Ps: i made complaint after complaints to you folks and most of these should be in your chart.I just don't have a good hand writing, and the strength to keep repeating and writing letters to explain my situation.I'm sure most of you will ignore this letter, and nothing will be done about it.These bad drugs should be taken off the market, and these other implant products should be taken off the market like the one that was implanted that caused harm, and they should pay a penalty and have them pay for our pain, suffering and that caused me out of pocket expenses.These mfr should pay a big fine-penalty for selling these products.I was harm by these products.Someone should be reliable and responsible for my bladder, pelvic injury that destroy my life since these implants with more life time surgeries and ongoing f/u care.Phase 1: (b)(6) 2015; phase 2: (b)(6) 2015; (b)(6) 2016 battery placement.Due to over steaming my left foot was curling, numb, pain, bump swelling on top of foot shocking pain, couldn't control device.(b)(6) 2017 battery replacements due to shortage in battery was running low and need another implant surgery.Did call dr and medtronic, they had to send me another device.I did not fix my left side of foot, toes got affected by the device.Scarring tissues causing chronic pain, complications, bleeding, self catheterization, incontinence, bloated couldn't urinate, "eik", pelvic discomfort, uti - using daily antibiotic since mesh implanted in 2015, burning - using multiple pads, using daily tylenol - ibuprofen, ongoing surgery to further distance.Ongoing f/u to further distance.Feeling sharp labor, discomfort.Loss life enjoyment with spouse and family.Feeling depress, distress, loss self esteem, caused out of pocket expenses.Loss sexual activity with spouse."ps: why am i telling you folks all this, is this going to help me for my pain, suffering and appts." device over steam gave shocking pain, could not control.Device was not working properly.X-ray on left foot (b)(6)2017.Catscan on spine due to wearing the device implant of buttocks (b)(6)2017.Implanted device was over steaming, did not function or work properly.Couldn't control to set it properly, numbers were going up and high on its own that was giving me shocking pain on left toes and foot that i was getting shocking and burning pain on left foot.Implant pacemaker caused numbness, swelling to my right foot, was left with a bump caused toe to curl on left.
 
Event Description
Additional information received from reporter on 11/17/2017: patient states that this is a continuation of an ongoing situation.She will have to bear no weight on her left foot for 6 weeks post surgery, after which she will get a surgical foot brace.Due to batteries not lasting as long as expected, she has also been scheduled to go for follow up visits every 6 months.
 
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Brand Name
GYNECARE JOHNSON & JOHNSON TVT MESH IMPLANT
Type of Device
GYNECARE JOHNSON & JOHNSON TVT MESH IMPLANT
Manufacturer (Section D)
ETHICON / JOHNSON & JOHNSON
MDR Report Key6593638
MDR Text Key76261416
Report NumberMW5070041
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 11/17/2017
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Disability;
Patient Age53 YR
Patient Weight65
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