November 21, 2009 - 10:13am
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: firstname.lastname@example.org