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

It has now been one year and two weeks since a Coloplast Virtrue 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 my 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

Post Edited (male_sling_problems) : 7/31/2010 10:31:33 AM (GMT-6)

So sorry to hear you are still having such acute pain problems. At first it sounded like the pain was gone after you had the Advance sling inplanted.

It's such an irony that I now have both a Coloplast Virtue Sling and and AMS AUS 800 in my body with little pain. Three weeks following the Virtue Sling surgery my pain was all but gone even though my incontinence returned. The same thing with the AUS surgery. I passed the three week mark last week and pain is all but gone from both the sling and the AUS. Although the sling did little to solve my incontinence the pain seemed no different from all the others that I have seen post after their experience from sling surgerys. Now I am just hoping the AUS will solve the incontinence once it is activated in three more weeks.

I wish you the best to get this problem solved.

Hey MSP, Sorry to hear about you trouble. First thing I would do is hire a Lawyer and sue the crap out of them. Second, if you are anywhere near Dallas Tx. or would consider going there, check with Dr. Alen Morey. Not only is he a AUS and IPP "hot shot" but he is also a former Army Doctor that has done many bladder reconstructions. He did my AUS as well as a few other guys here on the board.
Wish you well.
Kw

Hello KW and Tallguy,

Thanks for the comments.

I noticed last night that Coloplast just launched a second "Clinical Trial" for their Virtue sling. I believe they began recruiting on the 27th of July. They state that this clinical trial is focused on "fixation" of the Virtue sling. I am guessing that this could indicate they are having problems with the sling migrating out of position following the initial implant procedure.

This seems somewhat ironic to me since one of the major selling points of their Virtue sling was that their new four-armed design would hold the polypropylene mesh more securely in place.

At least in clinical trials, volunteers are informed of the risk and give their written consent. I wish them good luck!

Best wishes,

John

Hello Mom 2 love,

If you click on my user name (male_sling_problems) you will see my email address. Send an email to me and I will give you my phone number.

Hopefully I can help you find some relief from your pain.

It appears to me that Coloplast's Virtue sling is repeatedly causing extended severe pain that sling recipients were not anticipating.

The Virtue sling that was implanted in my body July 2009 absolutely destroyed my quality of life and almost my life its self due to intolerable pain. I have experienced some reduction in pain since I had the Virtue polypropylene platform surgically removed from my scrotum December 2009 but much pain persist.

My scrotum continues to be extremely sore to touch and the lower "arms" of the Virtue Quadratic sling, that are wrapped around my lower pubic ramis bones feel like I am sitting on two steel cables when I am seated. I hope to have additional surgery in the future to have more of the Coloplast sling mesh cut out of my body.

Unfortunately others are suffering like we are. For example, I received an email from a man in Florida yesterday extremely distraught due to his suffering caused by his Virtue sling implant. He has suffered for four months and is desperate for some relief.

He intends to contact the reconstructive surgeon that removed the Virtue mesh platform from my scrotum in hopes some similar surgery will make his situation more bearable.

Best regards,

John

Hello David,

Thanks for responding. In my way of thinking, if there is anything worse than constant pain it is AVOIDABLE constant pain.

I do not understand why a male sling manufacturer would permit, much less encourage, its sling to be implanted in unsuspecting individuals until they have completed their clinical trials. Two of the main purposes, of these clinical trials are to determine if a device works and if it can be tolerated (including pain) in a human body.

In my situation,with the Coloplast Virtue sling, even after having a portion of the Virtue mesh surgically removed the suffering continues almost two years following the implant surgery. I am now of the opinion that my scrotal nerves have suffered permanent damaged.

I agree with Mom 2 love that the FDA should step in and protect unsuspecting cancer survivors from this avoidable suffering.

Best wishes to all,

John