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COLOPLAST VIRTUE SLING / Continuous pain and suffering one year later.

bigxbadxjohn3
Posts: 20
Joined: Dec 2009

It has now been one year and two weeks since a Coloplast Virtue sling was implanted in my body without my consent. I had consented to simple and well proven AdVance or AdVance type sling, not a 4-armed contraption (Virtue Quadratic Sling) undergoing clinical trials. I feel like I am a victim of “bait and switch”.

The Virtue sling not only worsened my incontinence from 1-2 to 4-6 pads per day. To make matters worse, the pain has been continuous and intolerable for more than one year following surgery. At approximately five months following the initial implant, I urinary specialist at The Cleveland Clinic removed part of the polypropylene mesh sling, mainly the part which felt like a notched credit card sewn inside my scrotum.

Near the completion of this 3 ½ hour surgery, the doctor implanted an AdVance sling manufactured by American Medical Systems (this is the sling that I had consented to). It is working fabulous. I have not requires a single pad since the AdVance sling was implanted last December.

In spite of this success, I continue to have major pain issues due to the original implant. The surgeon stopped short of removing the Virtue’s polypropylene mesh arms that were wrapped around my lower pelvic bones aka pubic rami. For me, this polypropylene mesh wrapped around (anchored) my lower pelvic bones, causes intolerable pain when seated. It feels like I am sitting on a piece of coarse hemp rope that has the sensation of tearing the internal flesh inside my lower pelvis when I shift my weight attempting to reduce the pain.

In addition to the sitting pain, my scrotum skin remains extremely painful “to the touch”. It somewhat resembles the pain of a bad sunburn but the pain sensations penetrate deeper into my scrotum. I am of the opinion that I have suffered significant and most likely permanent scrotal nerve damage from this Coloplast Virtue sling fiasco.

I am now planning to schedule another appointment with a pelvic reconstruction specialist at The Cleveland Clinic. The purpose of this appointment will be to learn if it is possible to cut or scrape (remove) more of the Virtue polypropylene mesh that is wrapped around my lower pelvic bones. My hope is that by removing these “high spots” from my bones, it will lessen the sensation of sitting on a rope and the perhaps give the surrounding bruised tissue an opportunity to begin healing.

Others may have a better outcome with the Virtue sling but for me it has been a medical disaster. I am somewhat like BP’s Tony Hayward, I would like to get my life back.

Best regards,

John

Trew
Posts: 897
Joined: Jan 2010

BigX, I feel your pain- I'm sure all of us can. I don't understand how doc's can go ahead and just do things like this? Discussing my own incontinence with my uro- he wants nothing to do with slings of any kind. And even then, I am going to have my AUS done at UofM Ann Arbor, but even getting the best doctor you can find doesn't always guarentee a good outcome. But in your case, this is just not right.

I wish you well on this.

Best regards,

Trew

bigxbadxjohn3
Posts: 20
Joined: Dec 2009

Hello Trew,

Thanks for the support.

Ironically, I agreed to participate in a clinical trial ten years ago during my open prostatectomy. The surgery was performed at a major urology-oncology center. I agreed to let them try a new machine to capture lost blood, process the blood and return it to my body making donor blood unnecessary. For some reason, the machine malfunctioned and more that three quart of my blood went down the drain. Following this unexpected event, I was given a zero chance of survival. Lucky for me, I beat the odds.

In spite of my experience with this clinic trial, I NEVER complained. I knew the risk and made an "informed consent" to participate. I have always hoped my contribution advanced the art of caring for those requiring major surgery.

This recent sling ordeal is very different. I was described the AdVance sling in great detail. This is the surgery that I consented to. I had never heard of a Coloplast Virtue sling. You can imagine my surprise to learn that a relatively untested device, of a new design, had been implanted into my body without my consent.

In spite of my horrible experience with the Coloplast Virtue sling, I am very much pro-sling. The AdVance sling is working fantastic for me. I can engage in any activity and not loose a drop of urine. Following ten years of wearing pads, I have not required a pad since the Virtue sling was removes (in part) and the AdVance sling was implanted last December. I am 100% convinced that all of my pain and suffering today results from the initial Virtue implant.

Best wishes,

John

Trew
Posts: 897
Joined: Jan 2010

I never imagined how much incontinency can mess up one's life until I became immersed in it. Like today- again- I wet 3 pairs of underwear and two pair of pants- and that with pads on. I would guess around 10 pads today- very typical day. So any decision on a fix is very very important- and should be well thought out before the surgery and then executed by the doc team to a tee- no surprises.

I personally am afraid of any sling and plan to get the AMS 800 Sphincter- I think I have the most confidence in that device. this has to work- no mistakes. If I find out 2- 3 months after surgery that I am still using 4+ pads a day, I think I will have an emotional meltdown. This is very serious stuff to those of us caught up in it. The real word I would use is: nightmare.

I hope something can be done for your pain levels.

bigxbadxjohn3
Posts: 20
Joined: Dec 2009

Hello Trew,

You might consider making an appointment with a urologist that specializes in incontinence at the Cleveland Clinic. You do not need a referral. The urology-oncology department there is often rated #1 in the USA.

You will not be guaranteed a "fix" but you will have the benefit of being treated by one or more of the most qualified doctors in the world.

My last December surgery, which involved removing the Virtue sling and implanting the AdVance sling was like a life saver for me. I was struggling to "go on" with the increased incontestably and intolerable pain the followed the Coloplast Virtue sling implant last July.

In spite of the injury to my body caused by the Virtue fiasco, the surgeon at the Cleveland Clinic was able to successfully implant a AdVance sling. As I mentioned earlier, I am now 100% dry for the first time in more than ten years.

The point I am trying to make, when considering surgery for incontinence, I can not understate the importance of dealing with highly experienced experts and, with their guidance, choose your plan of action (device) very carefully.

Best wishes,

John

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

I'd consider an appointment with a lawyer who specializes in malpractice suits.

bigxbadxjohn3
Posts: 20
Joined: Dec 2009

Hello Kongo,

Thanks for the consideration. At this time I am concentrating my energy on a return to pain free health.

Best wishes,

John

Trew
Posts: 897
Joined: Jan 2010

BigX, I appreciate the recommendation. Having been through this you know what is involved. I have decided to use Dr. Latini at UofMichigan in Ann Arbor to get me dry. You didn't need to have a urethroplasty done before the sling, did you? Looks like I will and Dr Latini is good at those and once she has her hands on that part of my body I plan to stay with her since she will know about the repair to my urethra. Ah, my dear urethra! How well I am becoming acquainted with it myself these days.

Maybe I can get some pictures for framing?

bigxbadxjohn3
Posts: 20
Joined: Dec 2009

Hello Trew,

My two sling surgeries did not require a urethoplasty. Only a cyscoptomy was required before each surgery.

Best wishes at Ann Arbor. It is a great hospital too!

John

ejn's picture
ejn
Posts: 64
Joined: Jun 2010

I would make sure that I did not let too much time pass and lose the right to litigate. You are going through enough already then to deal with a mistake like that. The issue seems to be that it was not a mistake but a planned experiment on your body without consent. But hey...it's your body and your well being that needs to be considered and of course your decision.

Trew
Posts: 897
Joined: Jan 2010

Scar tissue keeps closing down my urethra- self cath isn't going to solve the problem so the urethroplasty is called for to rebuild that section of the urethra. I would like to find someone who has had this surgery already but I do understand it is bit rare and a bit complicated. My uro in Kalamazoo is the one sending me off to UM for this eval and procedure. It is his opinion one is needed and he was not going to attempt any AUS installation until the stricture problem is addressed.

All goes with the road less traveled, I guess.

Medical stuff is now my new hobby. I'm really getting into this and I'm enjoying expanding both my vocabulary and experience and meeting lots of new people. Ture, usually I 'm the only one in the group with my clothes off......but.........

GatorDad's picture
GatorDad
Posts: 6
Joined: Aug 2010

Sorry to hear of your problems with the Virtue Sling.

On the other side of that coin, I had the Coloplast Virtue "installed" in Dec '09 and I'm extremely happy with the results. I suspect the efficacy of this device is much like most things - it depends on your doctor.

I made it clear to my Uro that I would be happier with an 80% solution, rather than him going for a 100% solution and messing me up worse (urinary retention). He did the 80% solution perfectly. A few days post-op I was down to 1 pad a day (from 4/6). It's now August and I'm down to zero pads. I still have the Cunningham clamp I use for public outings (just in case), but overall, I couldn't be happier with the Virtue Sling.

cheers & beers...
Chris

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