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Deepening Problems for Coloplast Virtue Male Sling

bigxbadxjohn
Posts: 15
Joined: Oct 2009

Since I continue to suffer since the implantation of Coloplast's Virtue male sling, more than four months ago; each week I check FDA's MAUDE Reports for physician reported injurious Adverse Events, requiring intervention, regarding the Coloplast Virtue Male Sling.

This past week, the number of reported Adverse Reports grew from eleven (11) to thirteen (13). I think this is a HUGE number considering the relative small number of Coloplast Virtue male slings implanted to date. My Adverse Event has not yet been added to this list.

I have been talking to the FDA about stopping this madness. I have read Coloplast application to the FDA for their required 510(K) pre-market approval. In their application, they told the FDA that their Virtue male sling was "substantially equivalent" to American Medical System's AdVance male sling.

I fail to understand how an obtrusive, four (4) armed device, constructed of a different mesh design and requiring a more invasive implant procedure, with greater risk of problems during surgery(breakage), followed by greater risk of post-implant complications can be "substantially equivalent" to a proven, two armed, non-obtrusive device which requires a less invasive implant procedure. I firmly believe this needs further investigation by the FDA.

During the last ten years, I have experienced four major surgeries, not including the Coloplast Virtue male sling implant. These surgeries included open prostatectomy, open left rotator cuff repair, open right rotator cuff repair including a major muscle transfer from my back and an open hernia repair. For me, this recent Coloplast sling surgery has caused more misery than all my previous surgeries combined.

I am scheduled for surgery, at The Cleveland Clinic, on the 17th of December, 2009. The plan is to have as much of the Coloplast Virtue sling cut out of my body as possible. My surgeon told me it will be impossible to remove all of the mesh material. He hopes to be successful in removing most of the lower mesh arms and the hard mesh platform that is causing so much pain in my scrotum area.

My doctor is also hopeful that he can remove enough of the mesh material, that is wrapped around my lower pelvic bones (aka rami), to effectively eliminate or lessen the "sitting on a broom handle" pain that I have been enduring when seated.

I am very excited about having this contraption removed from my body. I am considering it an early Christmas present to myself!

I would appreciate hearing from others that are experiencing similar problems with this device. My email is: bigxbadxjohn2@yahoo.com

tpelle
Posts: 184
Joined: Aug 2003

BBJohn: Thanks for your situation review. I'm glad to hear that the repair surgery has been scheduled. Sorry it has to be several weeks away. You had mentioned that your surgeon would evaluate the possibility of installing an AdVance at the same time. Although I'm sure your immediate goal is to rid yourself of Virtue and its consequences, is an AdVance installation still a possibility? Has your surgeon ever had to "fix" AdVance installations? We'll be waiting to hear the outcome of your surgery on the 17th of next month. God Speed. tpelle

bigxbadxjohn
Posts: 15
Joined: Oct 2009

Hello Tpelle,

Thanks for the well wishes. I never thought that I would live long enough to wish for surgery for my own selfish early Christmas present but it is 100% true.

My surgeon at The Cleveland Clinic will be Dr. Kenneth Angermeier. He, along with Dr. Kurt McCammom, Sentara Hospital, Norfolk, Va are among "top docs" for the AdVance sling implant procedure.

I was told by Dr. Angermeier that, prior to the Coloplast Virtue implant, I was the ideal candidate for male sling surgery. I had used 1-2 pads per day, for the last ten years, and had not received pelvic radiation.

I will be evaluated, during the Coloplast Virtue removal surgery, to learn if an AdVance sling can be implanted during this procedure or if healing will need to occur first. If my condition will not permit the implantation of an AdVance sling at this time, I will return to The Cleveland Clinic in the spring for the AdVance procedure.

Since the AdVanced sling design does not have the tensioned lower arms and scrotal platform that keeps the scrotal nerves in a state of extreme irritation, I do not anticipate any long term discomfort with the AdVance sling.

I was told that my Coloplast Virtue fiasco somewhat compromises the "dry" outcome that I am ultimately hoping for but I can only go forward from here. My surgeon is of the opinion that he can end my incontinence with the AdVance sling.

I am willing to answer any questions that arise and will keep CSN informed of the outcome of my upcoming surgery.

Happy Thanksgiving to all,

John

garbeller's picture
garbeller
Posts: 3
Joined: Nov 2014

If your doctor recommends this horrible product be installed in your body, leave his office immidiatly and never go back. He is an uninformed doctor. This product has caused me many, many problems. 

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