Coloplast Virtue Make Sling Coming Out!

I was implanted with a Coloplast Virtue male sling the 14th of July 2009. It has been one of the most miserable experiences of my life. It not only worsened my incontinence but has caused intolerable pain 24/7. I fail to understand how such a tortuous device can be legally implanted into a human body. I would prefer water boarding compared the pain and discomfort from this device. At least with water boarding, there are times of no torture when the water stops.

My Coloplast Virtue sling will be cut out of my body at The Cleveland Clinic on the 17th of December 2009. Parting company with this contraption will be the best Christmas present in the world for me.

I know of others facing the same outcome with this device. If you are suffering in silence, I would like to hear from you. My email is: [email protected]

Happy Thanksgiving to all,

John

Hello David,

Thanks for writing. My urologist offered nerve blocks but I declined. I am using Vicodin to sleep at night but I do not want to become dependent on narcotic pain medications.

To add insult to my injury, I never was informed or consented to a Coloplast Virtue sling. My urologist described the AdVance sling in great detail including its 85% success rate for the last three years. He also explained how it was minimally invasive and non-obtrusive. He described it as a little U shaped piece of mesh that looped under the neck of the bladder to take stress of the sphincter valve. He told me that this sling was rapidly becoming the new Gold Standard, replacing the Artificial Sphincter Valve as the precious choice for male incontinence.

I believe the AdVance male sling has significant advantages. It does not have a hard feeling platform, inside the scrotum, compressing, irritating and possibly permanently damaging scrotal nerves. Additionally, it does not have the lower arms, that are wrapped around my lower pelvic bones (rami), which were tightly tensioned to force the hard feeling platform, in my scrotum, upward against my scrotum nerves and other scrotal tissue.

I have been reading in the FDA MAUDE Adverse Event Reports where many of these lower arms are breaking, during the implant procedure, due to the amount the amount of tension being applied to compress the tortuous scrotum platform against the nerves and tissue in the scrotum. Other reports, to the FDA are due to extreme scrotal pain. For me, the pain from this mostly untested device, has been a living hell. I would not do this to an animal.

I plan to continue to encourage the FDA to stop the Clinical Trials to prevent further unnecessary pain and suffering. I have noticed that Coloplast told the FDA that their Coloplast Virtue male sling was "substantially equivalent" to American Medical System's AdVance male sling when they applied for and received their 510 (k) pre-market approval.

The Coloplast Virtue male sling has a scrotal platform and tightly tensioned lower arms that do not exist with the AdVance design. It is this "hard feeling" platform and lower tensioned mesh arms, wrapped around my lower pelvic bones that are causing continuous intolerable pain.

I would suggest to anyone considering a male sling to educate themselves well first and ask a lot of questions. Then make certain your doctor implants the sling of your choice and is not swayed by a device manufacture relationship.

Best wishes,

John