Coloplast Virtue sling / continuous pain and discomfort

I was implanted with a Coloplast Virtue sling. without my consent, approximately 2 ½ years ago. I had consented to a well-proven AdVance type sling, not a four-armed contraption that had recently began clinical trials.

The Virtue sling implant not only resulted in intolerable pain but also made my light incontinence MUCH worse. Due to continuous severe pain issues and increased pad usage, a reconstructive surgeon removed a portion of the Virtue sling mesh five months following the initial implant; then implanted an AdVance sling before I left the operating room.

Although I still suffer severe pain issues from the remnants of the Virtue sling mesh, which remains in my body, the AdVance sling ended my incontinence after using 1-2 pads per day for approximately nine years.

Regarding current pain, when I sit, it feels like I am sitting on two steel cables. I cannot tolerate sitting on steel folding chairs, bleachers or any unpadded seats. I believe this pain is caused by the Virtue mesh that was wrapped and remains wrapped around my lower ramis bones. I believe the mesh was wrapped around my ramis bones to secure the lower two arms of the Virtue sling.

I am of the opinion the wrapped mesh has hardened and now results in “high spots” on my lower pelvic bones. This pain, which feels like deep bruises, also extends down the backsides of both legs, especially when stooping to put on shoes and socks.

I tried to schedule surgery with three separate orthopedic surgeons to remove this wrapped mesh but they all considered the surgery too risky so it appears I am stuck with a lifetime of pain.

Additionally, my scrotal skin remains too sore to touch without hollering or jerking. I attribute this pain to scrotal and associated nerve damage caused by the Virtue sling fiasco.

I also suffer pain in the creases of both legs, which is greatly aggravated by clothing touching my skin in this area. It often feels like bee stings. There were significant incisions in the creases on both sides, five months apart, so once again, I believe this pain is due to trauma to the nerves.

I have posted updates to my ordeal, not to discourage sling surgery, but to stress the importance of due diligence when choosing a sling and surgeon.

Sling surgery is a life changing decision. It is so important to ask a lot of questions and “get it right” the first time around.

Best wishes,

John

Hello Purgatory,

I did schedule an appointment with the Pain Management Center at the Cleveland Clinic. Beyond documenting my suffering, there was little they could due because I did not want to risk becoming addicted to narcotic medicines.

For those that are not familiar with the differences between the AdVance sling which I believe was launched in 2006 with approximately 20,000 implants to date and the Virtue sling which was launched June 2009 with ongoing clinical trials, the following links may help:

http://www.google.com/imgres?imgurl=http://urology.med.nyu.edu/files/urology/u6/male-sling-AMS_sm_web_03-09-09.jpg&imgrefurl=http://urology.med.nyu.edu/node/908&h=333&w=500&sz=38&tbnid=3cDURd8bjphZBM:&tbnh=80&tbnw=120&prev=/search%3Fq%3Dmale%2Bsling%26tbm%3Disch%26tbo%3Du&zoom=1&q=male+sling&docid=IpvLhVlBHIKt3M&hl=en&sa=X&ei=W779TtCiAcWwiQKL9NnBDg&sqi=2&ved=0CFwQ9QEwAw&dur=233

http://www.google.com/imgres?imgurl=http://www.straighttalk.net/wp-content/uploads/virtue_male_sling.jpg&imgrefurl=http://straighttalk.net/%3Fpage_id%3D189&h=360&w=375&sz=17&tbnid=wpwg4Cn5OIXyAM:&tbnh=90&tbnw=94&prev=/search%3Fq%3Dmale%2Bsling%26tbm%3Disch%26tbo%3Du&zoom=1&q=male+sling&docid=1EZvM1SBD6HhVM&hl=en&sa=X&ei=zb79TqT4LMnniAL7xvGADQ&sqi=2&ved=0CFkQ9QEwAg&dur=919

Looking at the second link, for the Virtue sling, one can clearly see where the mesh material is wrapped around the lower ramis bones. It is my opinion that this wrapped mesh resulted in raised areas on the bottom side of my pelvis which causes pain whenever seated. It also feels like this mesh has migrated rearward which adds to the discomfort.

By viewing the two links, one can see there are major differences between these two designs. The AdVance is basically a piece of surgical tape or ribbon which elevates the bladder and urethra. It is obvious the Virtue sling design is much more invasive and remains in clinical trials to learn if it is effective, safe and can be tolerated in a human body. My results were three thumbs down.

Please know, my reasons for posting on Healingwell is to be factual and informative striving to help those searching for solutions for their incontinence.

Keep in mind, others experiences with the AdVance sling and Virtue sling may have been (or will be) entirely different than mine so I encourage them to share their experiences on this wonderful site.

Best wishes for the coming new year,

John

Hello Purgatory,

To view an animation of a Virtue sling implant you can view the first 30 seconds of this link:

http://www.orlive.com/coloplast/videos/virtue-male-incontinence-sling

As you can see, this device and implantation is much more invasive than the AdVance type sling procedure that I consented to.

Regards,

John

Hello Jassman1,

To make matters worse (more painful) if possible, each of the four arms of the Virtue sling are tensioned to approximately 5 pounds pull.

For me, this compressed tissue and nerves causing mind numbing pain. The arms are tensioned so tight during implant they often separate from the main body of the sling.

For example, here is number 36 of 37 FDA Maude reports for Virtue sling adverse events:

COLOPLAST A/S VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM SURGICAL MESH
Model Number 5002011400
Event Date 09/27/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description

(b)(4). Arms broke after minimal tension applied. Another sling was used, and the arm broke on it as well. Product discarded & not available to return for evaluation. Surgery was aborted.


It would be interesting to know the total amount of suffering that this device has caused.

Best wishes,

John

Hello Jazzman1,

It is my understanding that the surgeons removed the center portion or "platform" of the Virtue sling, That is the part that the four arms are attached to. It felt like a credit card had been implanted in my scrotum with a "V" notch on the rear side. It is my assumption that the "V" notch was a result of two of the tensioned arms distorting the mesh platform.

Removing this portion of the mesh was a brutal procedure. I was in the operating room for approximately 3 1/2 hours. I would be my guess that the majority of time was spent delicately cutting the Virtue mesh from the ingrowth of my pelvic tissue. The remaining time would have been used to implant my AdVance sling.

The pain and recovery time from this procedure was MUCH worse that my open prostatectomy approximately ten years earlier. Much of the Virtue mesh remains in my body causing pain.

I have noticed repeatedly where Coloplast promotional material refers to this "platform" and associated tensioning of the four arms as "gentle compression". If this is gentle compression, I am the Dalia Lama.

You can click on this link to see the "platform" that caused me so much misery:

http://www.surgicalproductsmag.com/scripts/sfrellist.asp?RPTid=COMPLIST&CALLFROM=SFPGM&ACCT=0002534&RELtype=PR&CommonCount=0

Best wishes,

John

Post Edited (male_sling_problems) : 12/31/2011 9:41:40 AM (GMT-7)